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Sections: Correlations,
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Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug4640 | Venetoclax Wiki | 0.27 |
drug3089 | Part 2 - Placebo Wiki | 0.24 |
drug3090 | Part 2 - TL-895 Wiki | 0.24 |
Name (Synonyms) | Correlation | |
---|---|---|
drug2169 | Internet-based Cognitive Behavioral Therapy Wiki | 0.24 |
drug3104 | Patient Status Engine Wiki | 0.24 |
drug522 | BMS-986253 Wiki | 0.24 |
drug2044 | IO-202 Dose Escalation Wiki | 0.24 |
drug456 | Azithromycin 250 MG Oral Capsule Wiki | 0.24 |
drug2045 | IO-202 Dose Expansion Wiki | 0.24 |
drug1269 | Data registry Wiki | 0.24 |
drug3483 | Quality of life promotion Wiki | 0.24 |
drug3088 | Part 1 - TL-895 Wiki | 0.24 |
drug4250 | TAK-981 Wiki | 0.24 |
drug3482 | Quality of life assessment Wiki | 0.24 |
drug4050 | Spectrila® Wiki | 0.24 |
drug2055 | Ibrutinib Wiki | 0.24 |
drug2250 | Ixazomib Wiki | 0.17 |
drug3435 | Psychoeducation Wiki | 0.17 |
drug4675 | Virtual Reality Wiki | 0.17 |
drug1975 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.17 |
drug2036 | IMU-838 Wiki | 0.17 |
drug109 | ADCT-301 Wiki | 0.17 |
drug3271 | Placebo oral capsule Wiki | 0.14 |
drug3484 | Quality-of-Life Assessment Wiki | 0.09 |
drug2995 | Oseltamivir Wiki | 0.09 |
drug4112 | Standard of care Wiki | 0.04 |
drug3273 | Placebo oral tablet Wiki | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
D007938 | Leukemia, NIH | 0.75 |
D019337 | Hematologic Neoplasms NIH | 0.67 |
D007945 | Leukemia, Lymphoid NIH | 0.53 |
Name (Synonyms) | Correlation | |
---|---|---|
D015451 | Leukemia, Lymphocytic, Chronic, B-Cell NIH | 0.41 |
D015470 | Leukemia, Myeloid, Acute NIH | 0.41 |
D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH | 0.35 |
D007951 | Leukemia, Myeloid, NIH | 0.33 |
D008223 | Lymphoma, NIH | 0.30 |
D010007 | Osteochondritis NIH | 0.24 |
D054437 | Myelodysplastic-Myeloproliferative Diseases NIH | 0.24 |
D008258 | Waldenstrom Macroglobulinemia NIH | 0.24 |
D015479 | Leukemia, Myelomonocytic, Acute NIH | 0.24 |
D015477 | Leukemia, Myelomonocytic, Chronic NIH | 0.24 |
D015461 | Leukemia, Prolymphocytic, T-Cell NIH | 0.24 |
D015463 | Leukemia, Prolymphocytic NIH | 0.24 |
D009369 | Neoplasms, NIH | 0.17 |
D011289 | Preleukemia NIH | 0.17 |
D020522 | Lymphoma, Mantle-Cell NIH | 0.17 |
D009196 | Myeloproliferative Disorders NIH | 0.14 |
D009190 | Myelodysplastic Syndromes NIH | 0.14 |
D007239 | Infection NIH | 0.02 |
D003141 | Communicable Diseases NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0005526 | Lymphoid leukemia HPO | 0.53 |
HP:0005550 | Chronic lymphatic leukemia HPO | 0.41 |
HP:0004808 | Acute myeloid leukemia HPO | 0.41 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0012324 | Myeloid leukemia HPO | 0.33 |
HP:0002665 | Lymphoma HPO | 0.30 |
HP:0012325 | Chronic myelomonocytic leukemia HPO | 0.24 |
HP:0004820 | Acute myelomonocytic leukemia HPO | 0.24 |
HP:0005508 | Monoclonal immunoglobulin M proteinemia HPO | 0.24 |
HP:0002664 | Neoplasm HPO | 0.17 |
HP:0002863 | Myelodysplasia HPO | 0.14 |
HP:0005547 | Myeloproliferative disorder HPO | 0.14 |
Navigate: Correlations HPO
There are 18 clinical trials
This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in the presence of 17p deletion.
Description: ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
Measure: Overall Response Rate (ORR) Time: Measured up to 2 years after the last participant has enrolled in the study.Description: CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified iwCLL NCI-WG criteria.
Measure: Complete Response Rate (CRR) Time: Measured up to 2 years after the last participant has enrolled into the study.Description: DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
Measure: Duration of Overall Response (DOR) Time: Measured up to 2 years after the last participant has enrolled into the study.Description: PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
Measure: Progression Free Survival (PFS) Time: Measured up to 5 years after the last participant has enrolled into the study.Description: EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
Measure: Event Free Survival (EFS) Time: Measured up to 2 years after the last participant has enrolled into the study.Description: TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
Measure: Time to Progression (TTP) Time: Measured up to 5 years after the last participant has enrolled into the study.Description: Time to 50% reduction in ALC is defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC has reduced to 50% of the baseline value
Measure: Time to 50% reduction in absolute lymphocyte count (ALC) Time: Measured up to 2 years after the last participant has enrolled into the study.Description: OS is defined as number of days from the date of first dose to the date of death.
Measure: Overall Survival (OS) Time: Measured up to 5 years after the last participant has enrolled into the study.This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for first-line treatment of ALL patients of all age groups and showed similar efficacy and safety in comparison to Asparaginase medac no blinding or control groups are necessary. As underlying treatment protocol the BRALL 2014 treatment protocol will be used.
Description: Assessment of induction phase response, defined as subjects with asparaginase (ASNase) activity trough levels in serum ≥ 100 U/L in induction phase
Measure: Asparaginase (ASNase) activity trough levels Time: Day 21 until Day 31The primary objective of this study is to determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed/refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 Expansion.
Description: Severity grade will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which will be assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Measure: Phase 1: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Overall Response Rate (ORR) Time: From the first dose until best response is achieved (up to 4 years)Description: Severity grade will be evaluated as per the NCI CTCAE Version 5.0, except for CRS, which will be assessed by ASTCT consensus grading criteria.
Measure: Phase 2: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve CR and PR through the study (approximately 4 years), as determined by the investigator according to the RECIST V1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: ORR Time: From the first dose until best response is achieved (up to 4 years)Description: DOR is the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease for responders (PR or better) and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Duration of Response (DOR) Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to 4 years)Description: DCR is defined as the percentage of participants who achieve stable disease (SD) or better (determined by the investigator according to RECIST v1.1 criteria for solid tumors or Lugano classification for lymphoma) greater than (>) 6 weeks during the study in the response-evaluable population.
Measure: Phase 2: Disease Control Rate (DCR) Time: From the first dose until best response is achieved (up to 4 years)Description: TTR is defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Response (TTR) Time: From the date of first study drug administration to the date of first documented PR or better (up to 4 years)Description: TTP is defined as the time from the date of the first dose administration to the date of first documented progressive disease and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Progression (TTP) Time: From the date of first study drug administration to the date of first documented PD (up to 4 years)Description: PFS is defined as the time from the date of the first dose administration to the date of first documentation of progressive disease or death due to any cause, whichever occurs first and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Progression-free Survival (PFS) Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to 4 years)Description: OS is defined as the time from the date of the first dose administration to the date of death.
Measure: Phase 2: Overall Survival (OS) Time: From the date of first study drug administration to the date of death (up to 4 years)Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.
Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs Time: Up to 9 monthsDescription: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS) Time: Up to 9 monthsDescription: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).
Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating Time: Up to 9 monthsDescription: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.
Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from the first dose of TAK-981 to viral load negativity (below level of detection).
Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours Time: Up to 9 monthsA study to evaluate the safety and efficacy of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows: Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment. Stage 2: Enroll up to an additional 23 participants.
Description: ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) as their best response (per investigator assessment).
Measure: Overall Response Rate (ORR) Time: Up to approximately 2 yearsDescription: PFS is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death.
Measure: Progression-Free Survival (PFS) Time: Up to approximately 2 yearsDescription: DOR defined for participants who achieve a best overall response of CR, CRi, or PR, as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death.
Measure: Duration of Response (DOR) Time: Up to approximately 2 yearsDescription: TPP is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression.
Measure: Time to Progression (TTP) Time: Up to approximately 2 yearsDescription: EFS is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy.
Measure: Event-free Survival (EFS) Time: Up to approximately 2 yearsDescription: DCR defined as the percentage of participants achieving CR, CRi, PR, or stable disease as best overall response.
Measure: Disease Control Rate (DCR) Time: Up to approximately 2 yearsDescription: OS is defined as the time from the date of the participant's first dose of any study drug to death from any cause.
Measure: Overall Survival (OS) Rate Time: Up to approximately 2 yearsDescription: Number of eligible participants reaching autologous or allogeneic transplantation.
Measure: Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation Time: Up to approximately 2 yearsDescription: AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measure: Number of Participants with Adverse Events (AE) Time: Up to approximately 2 yearsThe purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.
Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy Time: Up to Day 29Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measure: Overall Response Rate (ORR) Time: Up to 30 monthsThe goal of this feasibility study is to determine if Virtual Reality (VR) can be adequately used as an alternative to General Anesthesia (GA) for Lumbar Punctures (LP).
Description: This is a feasibility study with the primary outcome defined as success of completion of the Lumbar Puncture with Virtual Reality.
Measure: Success of completion of the LP with VR Time: 4 monthsDescription: This is a numerical scale from 0 to 10, 0 being no pain, 10 being the worst possible pain.
Measure: Pain Visual Analogue Scale (Pain VAS) Time: 4 monthsDescription: The CAM-S is a vertical analog scale for child self-report of state anxiety. Children are asked to rate how nervous or worried they feel "right now" by marking a line on a visual depiction of a thermometer. Lines closet to the bottom of the thermometer indicate less worry, while lines towards the top of the thermometer indicate more worry. The scale ranges from Calm (score of 0) to very very nervous (score of 100)
Measure: Child Anxiety Meter-State (CAM-S) Time: 4 monthsDescription: The Children's fear Scale is a one-item scale that consists of a row of faces with expressions ranging from no fear (score of 0) to extreme fear (score of 4). Children are asked to choose the face that most closely reflects how anxious or fearful they are feeling.
Measure: Children's Fear Scale (CFS) Time: 4 monthsThis study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of participants infected with COVID-19. This is the first in-human study of this investigational product specifically in patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.
Description: The time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.
Measure: Time to Improvement in the 7-point ordinal scale Time: 1 yearDescription: The time to death will be defined as the time from onset from symptoms until death from any cause. Patients who are alive or lost to follow-up at the cut-off date will be censored from this analysis.
Measure: Time to Death Time: 1 yearDescription: The time to intubation will be defined as the time from symptom onset until time of intubation. Any patients already intubated at enrollment will be censored from this analysis.
Measure: Time to Intubation Time: 1 yearDescription: The proportion of patients requiring intensive care unit (ICU) admission will be calculated as the number of patients requiring ICU admission over the course of their hospitalization over the number of evaluable patients.
Measure: Proportion of patients requiring ICU admission Time: 1 yearDescription: Percentage of participants who have died 1 month from the time of start of treatment
Measure: Percentage Rate of Mortality at 1 month Time: 1 monthThis is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.
Description: The percentage of HM patients with COVID-19 who died.
Measure: To evaluate mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.
Measure: To evaluate potential predictive biochemical parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.
Measure: To evaluate potential predictive HM-related parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality
Measure: To evaluate COVID severity as predictive parameter of mortality. Time: At 2 months from study initiationDescription: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)
Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity Time: At 6 months from study initiationDescription: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.
Measure: Definition of complete clinical picture of COVID-19 in HM Time: At 2 months from study initiationDescription: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.
Measure: Evolution of HM Time: At 2 months from study initiationDescription: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).
Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics Time: At 2 months from study initiationTo assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D) and dose schedule as monotherapy.
Description: Incidence of adverse events
Measure: Safety of IO-202 as measured by incidence of adverse events. Time: From first dose of IO-202 to 30 days following last study treatmentDescription: Severity of adverse events
Measure: Safety of IO-202 as measured by severity of adverse events. Time: From first dose of IO-202 to 30 days following last study treatmentDescription: Incidence dose interruptions and dose reductions
Measure: Tolerability of IO-202 as measured by incidence and duration of dose interruptions and dose reductions of study treatment Time: From first dose of IO-202 to 30 days following last study treatmentDescription: Maximum concentration (Cmax) of IO-202
Measure: To characterize the pharmacokinetics (PK) of IO-202 as defined by maximum plasma concentration (Cmax) Time: Through study completion, an average of 1 yearDescription: measure area under the curve (AUC) of IO-202
Measure: To characterize the PK of IO-202 as defined by area under the curve (AUC) Time: Through study completion, an average of 1 yearDescription: Measure anti-drug antibodies in plasma.
Measure: To evaluate the incidence of anti-drug antibodies against IO-202 Time: Through study completion, an average of 1 yearDescription: Measure response rates in patients with anti-drug antibodies.
Measure: To measure rates of response to IO-202 in patients with anti-drug antibodies Time: Through study completion, an average of 1 yearDescription: Statistical correlation levels of target expression on leukemic blasts with response rate
Measure: To correlate target expression with response rates Time: Through study completion, a average of 1 yearDescription: Statistical correlation of target expression on leukemic blasts with adverse event rates
Measure: To correlate target expression with rates of adverse events Time: Through study completion, a average of 1 yearDescription: Measure immunophenotype of leukemic blasts from bone marrow aspirates after study treatment
Measure: To evaluate immunophenotype of leukemic blasts after study treatment. Time: Through study completion, a average of 1 yearThe purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.
Description: Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)
Measure: Time to identify and recruit dyads in months Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Feasibility, as measured by accrual rates of eligible participants
Measure: Accrual rates Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Feasibility, as measured by retention rate
Measure: Retention rate Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Feasibility as measured by completion of data collection across study timepoints
Measure: Data collection completion rate Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Acceptability, as measured by average acceptability scale scores, with overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.
Measure: Average acceptability scale scores Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Usability, as measured by average System Usability Scale scores. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores > 68 considered to be above average usability.
Measure: Average System Usability Scale scores Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores >7 will be considered acceptable. Mean and standard deviation to describe subjects' overall satisfaction with the intervention reported.
Measure: Mean caregiver satisfaction Time: 2 months post-hospital discharge, an average of 2 monthsDescription: End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction.
Measure: End-of-study caregiver satisfaction scores Time: 2 months post-hospital discharge, an average of 2 monthsDescription: Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Measure: Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores Time: Baseline, hospital discharge, 2 months post hospital dischargeDescription: Caregiver HRQOL, evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes.
Measure: Caregiver Healthcare Related Quality Of Life (HRQOL) Time: Baseline, hospital discharge, 2 months post hospital dischargeDescription: Distress as measured by the NCCN distress thermometer. Thermometer scores range from 0 to 10, with higher scores indicating worse distress. Prior to administration of the distress thermometer measure, each caregiver will be asked if they are experiencing distress related to Covid-19 (yes/no). The distress thermometer asking them to rate their distress in the past week including today. The Covid-19 variable will be included as a covariate in the analyses. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Measure: Distress as measured by the the NCCN distress thermometer Time: Baseline, hospital discharge, 2 months post hospital dischargeThe COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012. Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.
Description: Hematological pathology Description
Measure: Prognostic factors for healing of COVID-19 infection Time: Day 0Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosisDescription: Allow national epidemiological monitoring and regularly inform the hematology community.
Measure: national epidemiological monitoring Time: through study completion, an average of 2 yearsThe primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5. Time: 5 days of treatmentDescription: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)
Measure: Clinical evolution Time: up to 3 monthsDescription: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock
Measure: Proportion of patients progressing to a severe form Time: up to 3 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples
Measure: Evaluation of viral load drop Time: at day 10Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)
Measure: Tolerance of study treatment Time: up to 3 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: NK immunological study Time: at day 10 and day 30 after treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: Patient follow-up during 3 months : hematological status and associated therapy
Measure: Impact of the study treatment on the treatment of the hematological disease Time: up to 3 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: T immunological study Time: at day 10 and day 30 after treatmentSince emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to cause a wide range of clinical syndromes, from fever, dyspnoea and cough to respiratory failure and cardiac injury necessitating critical care support. A number of patients have a more indolent clinical course and can be safely managed in the community. Characterising the clinical course of Covid-19 infection in the oncology population and distinguishing this from other acute oncology presentations which can mimic Covid-19 is a key unmet research need. Current standard of care for monitoring patients at high risk of chemotherapy associated neutropenic sepsis involves asking them to contact their cancer centre when they feel unwell or develop a fever. No standard of care for monitoring ambulatory Covid-19 patients has yet been established. We hypothesise that using wearable biosensors to detect patients who exhibit 'red flags' for sepsis or deterioration due to Covid-19 may allow earlier assessment and intervention. There is no current evidence for wearable biosensors in ambulatory patients receiving chemotherapy, and there is no existing research into this proposed use of biosensors in patients with suspected or confirmed Covid-19 infection. In order to justify performing a randomised controlled study comparing standard of care with biosensor driven monitoring it is important to establish the tolerability and validity of these devices. We aim to collect patient reported outcome measures (PROMs) on tolerability and assess the reliability of data transmission to a central data collection server. We will also perform an initial analysis of physiological data and correlation with clinical events
Description: Percentage of patients who choose to stop wearing the devices before they have completed the study
Measure: Device Tolerability (Attrition) Time: Three weeksDescription: Correlation of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature.
Measure: Correlation of physiological data with clinical events Time: Over three weeks of patients wearing devicesDescription: Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again for the next three weeks'. This statement is included in the questionnaires completed after three weeks of wearing the device.
Measure: Device Tolerability (Questionnaire) Time: Questionnaire at three weeksDescription: Device tolerability as assessed by semi-structured interviews.
Measure: Device Tolerability (Semi-structured interviews) Time: One to four weeks after completion of wearing the deviceDescription: Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.
Measure: Reliability of data transmission Time: Over three weeks of patients wearing devicesThis study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.
Description: To determine the recommended dose of TL-895 to be used in Part 2 based on the observed dose limiting toxicity per dose level
Measure: Part 1 - Recommended dose of TL-895 Time: After the day 14 of the 6th subject per dose levelDescription: The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death
Measure: Part 2 - Change in the need for artificial ventilation or death Time: Day 29Description: The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death
Measure: Part 2 - Change in respiratory failure events that require invasive ventilation or death Time: 4 monthsThe COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.
Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Measure: Clinical prognostic factors for infection with COVID-19 Time: Day 0Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
Measure: Biological prognostic factors for infection with COVID-19 Time: Day 0Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosisThis is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.
Description: To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measure: HRQOL in adult patients with hematologic malignancies Time: After 2 years from date of registrationDescription: To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measure: Symptoms in adult patients with hematologic malignancies Time: After 2 years from date of registrationDescription: To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measure: Adherence to therapy in adult patients with hematologic malignancies Time: After 2 years from date of registrationDescription: To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)
Measure: Prevalence of clinically relevant functional limitations and symptoms Time: After 2 years from date of registrationDescription: To investigate factors associated with physical and mental health concerns
Measure: Factors associated with physical and mental health concerns Time: After 2 years from date of registrationDescription: To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
Measure: Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes Time: After 2 years from date of registrationDescription: To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
Measure: Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes Time: After 2 years from date of registrationDescription: To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios
Measure: Clinical strategies adopted by physicians Time: After 2 years from date of registrationThis is research study to find out if a drug called ADCT-301 is safe and to look at how patients respond to the study drug after an allogeneic transplantation. ADCT-301 will be administered on Days 1, 8 and 15 with blood tests following study drug infusion. Patients will have a bone marrow biopsy at the end of cycle 2/before cycle 3 to see how they are responding to the study drug. Patients will be followed for approximately every 12 weeks from the last disease assessment for up to 1 year from completion of therapy. There are risks to this study drug. Some risks include: decrease in certain blood cells, weight loss, loss of appetite, rash and Guillain-Barre syndrome, where the immune system attacks and damages nerves.
Description: Investigator report; efficacy rule
Measure: Morphologic complete response rate of ADCT-301 Time: End of Study, up to 3 yearsDescription: Number of adverse events as measured by self report
Measure: Safety of ADCT-301 Time: up to 12 weeks (84 days) after the last doseThis phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.
Description: Will calculate the proportion of patients who were outpatient at the time of study entry, and evaluate whether or not patients in this cohort required hospitalization associated with their coronavirus disease 2019 (COVID-19) infection.
Measure: Proportion of patients who require hospitalization for their COVID-19 disease or die (Cohort 1) Time: Up to 28 days after study registrationDescription: Will characterize and calculate the proportion of patients who develop a "flare phenomenon" if ibrutinib is stopped. Will calculate corresponding 95% exact binomial confidence intervals for these outcomes. These will be graphically and quantitatively compared, where chi-square or Mantel-Haenszel-Cochran tests will be used to compare the numbers of patients who have the incident event of interest between treatment arms or other groups of interest.
Measure: Rate of "flare phenomena" (Cohort I) Time: Up to 84 daysDescription: We will evaluate and characterize baseline status and changes in 8 primary COVID-19 related symptoms in these outpatient subjects: fever, loss of smell, cough, shortness of breath, fatigue, aching muscles, diarrhea, and decreased appetite. These will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Resolution of symptoms will be defined as no fever, no loss of smell, and severity or frequency of the remaining six symptoms rated as 0 (none/never) or 1 (mild/rarely) on the PRO-CTCAE.
Measure: Patient-reported health and symptom status (Cohort I) Time: Up to 84 daysDescription: We will characterize and summarize overall and by B-cell histologic diagnosis whether or not patients suspend their ibrutinib therapy while in an outpatient setting during the first 28 days on study, and patterns of resumption of ibrutinib. Specifically, we will evaluate this outcome by assessing the number of days patients received ibrutinib in the first 28 days after enrollment on this trial.
Measure: Patterns on ibrutinib therapy during COVID-19 infection (Cohort I) Time: Up to 84 daysDescription: Will characterize and summarize the need for and duration of oxygen supplementation.
Measure: Intubation and oxygen supplementation (Cohort II) Time: Up to 84 daysDescription: The proportions of patients who are documented as having viral clearance at the various time points will be summarized at each time point within each treatment arm. These proportions will be evaluated within as well as across the cohorts. Within each cohort, we will compare these rates at each of the time points using chi-square or Mantel-Haenszel-Cochran tests to assess differences between treatment arms or groups. Further, logistic regression models will be used to assess incidence of viral clearance and how treatment arm and other demographic and clinical factors affect the ability of patients to achieve viral clearance.
Measure: Viral clearance Time: On days 15, 28, 42, and 56 after registrationDescription: The proportion of patients who are able to develop COVID-19 antibodies by days 15 and 28, defined as the number of patients who have a threshold level of detectable COVID-19 antibodies divided by the total number of patients in the specific cohort/arm.
Measure: Development of COVID-19 antibodies Time: Up to 28 daysDescription: Will evaluate the baseline as well as change in plasma cytokines between treatment arms: IL-1beta, IL-1Ralpha, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL- IL-9, IL-10, IFNgamma, IP10, TNFalpha in longitudinal samples.
Measure: Cytokine measures Time: Up to 84 daysDescription: Will evaluate the baseline as well as change in several immune cell subsets, including CD3 T cells, CD4 T-helper cells (and their subsets), CD8 T-suppressor cells (and their subsets), NK cells, B cells, and monocytes.
Measure: Immune subset measures Time: Up to 84 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports