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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4640 | Venetoclax Wiki | 0.37 |
| drug2044 | IO-202 Dose Escalation Wiki | 0.32 |
| drug2045 | IO-202 Dose Expansion Wiki | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1269 | Data registry Wiki | 0.32 |
| drug4050 | Spectrila® Wiki | 0.32 |
| drug2055 | Ibrutinib Wiki | 0.32 |
| drug2250 | Ixazomib Wiki | 0.22 |
| drug4675 | Virtual Reality Wiki | 0.22 |
| drug2036 | IMU-838 Wiki | 0.22 |
| drug109 | ADCT-301 Wiki | 0.22 |
| drug3484 | Quality-of-Life Assessment Wiki | 0.12 |
| drug2995 | Oseltamivir Wiki | 0.12 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007945 | Leukemia, Lymphoid NIH | 0.71 |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell NIH | 0.55 |
| D015470 | Leukemia, Myeloid, Acute NIH | 0.55 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH | 0.47 |
| D007951 | Leukemia, Myeloid, NIH | 0.45 |
| D008223 | Lymphoma, NIH | 0.40 |
| D010007 | Osteochondritis NIH | 0.32 |
| D054437 | Myelodysplastic-Myeloproliferative Diseases NIH | 0.32 |
| D008258 | Waldenstrom Macroglobulinemia NIH | 0.32 |
| D015479 | Leukemia, Myelomonocytic, Acute NIH | 0.32 |
| D015477 | Leukemia, Myelomonocytic, Chronic NIH | 0.32 |
| D015461 | Leukemia, Prolymphocytic, T-Cell NIH | 0.32 |
| D015463 | Leukemia, Prolymphocytic NIH | 0.32 |
| D011289 | Preleukemia NIH | 0.22 |
| D020522 | Lymphoma, Mantle-Cell NIH | 0.22 |
| D009196 | Myeloproliferative Disorders NIH | 0.18 |
| D009190 | Myelodysplastic Syndromes NIH | 0.18 |
| D009369 | Neoplasms, NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001909 | Leukemia HPO | 0.75 |
| HP:0005526 | Lymphoid leukemia HPO | 0.71 |
| HP:0005550 | Chronic lymphatic leukemia HPO | 0.55 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004808 | Acute myeloid leukemia HPO | 0.55 |
| HP:0012324 | Myeloid leukemia HPO | 0.45 |
| HP:0002665 | Lymphoma HPO | 0.40 |
| HP:0012325 | Chronic myelomonocytic leukemia HPO | 0.32 |
| HP:0004820 | Acute myelomonocytic leukemia HPO | 0.32 |
| HP:0005508 | Monoclonal immunoglobulin M proteinemia HPO | 0.32 |
| HP:0002863 | Myelodysplasia HPO | 0.18 |
| HP:0005547 | Myeloproliferative disorder HPO | 0.18 |
| HP:0002664 | Neoplasm HPO | 0.05 |
Navigate: Correlations HPO
There are 10 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 31A 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 monthsTo 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 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 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 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