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D008223: Lymphoma

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (15)


Name (Synonyms) Correlation
drug4709 Voraxaze Wiki 0.32
drug5023 leucovorin Wiki 0.32
drug1269 Data registry Wiki 0.32
Name (Synonyms) Correlation
drug1788 Glucarpidase Wiki 0.32
drug894 Camidanlumab Tesirine Wiki 0.32
drug3987 Sintilimab Wiki 0.32
drug2250 Ixazomib Wiki 0.22
drug3714 Rituximab Wiki 0.22
drug2036 IMU-838 Wiki 0.22
drug4640 Venetoclax Wiki 0.18
drug2599 Methotrexate Wiki 0.16
drug2055 Ibrutinib Wiki 0.16
drug3484 Quality-of-Life Assessment Wiki 0.12
drug2995 Oseltamivir Wiki 0.12
drug297 Anakinra Wiki 0.10

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D007945 Leukemia, Lymphoid NIH 0.57
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.55
D016393 Lymphoma, B-Cell NIH 0.45
Name (Synonyms) Correlation
D007938 Leukemia, NIH 0.40
D006689 Hodgkin Disease NIH 0.32
D010007 Osteochondritis NIH 0.32
D016403 Lymphoma, Large B-Cell, Diffuse NIH 0.32
D008258 Waldenstrom Macroglobulinemia NIH 0.32
D008228 Lymphoma, Non-Hodgkin NIH 0.32
D020522 Lymphoma, Mantle-Cell NIH 0.22
D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.16
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.01

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0002665 Lymphoma HPO 1.00
HP:0005526 Lymphoid leukemia HPO 0.57
HP:0005550 Chronic lymphatic leukemia HPO 0.55
Name (Synonyms) Correlation
HP:0012191 B-cell lymphoma HPO 0.45
HP:0012539 Non-Hodgkin lymphoma HPO 0.32
HP:0012189 Hodgkin lymphoma HPO 0.32
HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 0.32
HP:0001909 Leukemia HPO 0.30

Clinical Trials

Navigate: Correlations   HPO

There are 10 clinical trials


1 A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Presence of 17p Deletion

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.

NCT02966756
Conditions
  1. Chronic Lymphocytic Leukemia (CLL)
  2. Small Lymphocytic Lymphoma (SLL)
Interventions
  1. Drug: Venetoclax
MeSH:Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma

Primary Outcomes

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.

Secondary Outcomes

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.

Measure: Percent of participants who move on to stem cell transplant

Time: Measured up to 2 years after the last participant has enrolled into the study.
2 LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma

The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL.

NCT03684980
Conditions
  1. Central Nervous System Lymphoma
Interventions
  1. Drug: Voraxaze
  2. Drug: Methotrexate
  3. Drug: Rituximab
  4. Drug: leucovorin
  5. Drug: Glucarpidase
MeSH:Lymphoma
HPO:Lymphoma

Primary Outcomes

Description: All serum samples will be tested via MTX immunoassay (measures MTX levels in addition to byproducts) as well as HPLC or mass spectroscopy which will reveal plasma concentrations of MTX and DAMPA separately.

Measure: number of patients that have significant reduction of serum methotrexate levels

Time: 1 year
3 Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma

The 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.

NCT03888534
Conditions
  1. Precursor Cell Lymphoblastic Leukemia-lymphoma
Interventions
  1. Drug: Ixazomib
MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia Lymphoma

Primary Outcomes

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 29

Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time: Up to 30 months

Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters

Time: Up to 30 months

Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib

Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib

Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Secondary Outcomes

Description: 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 months
4 A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

NCT04052997
Conditions
  1. Relapsed Hodgkin Lymphoma
  2. Refractory Hodgkin Lymphoma
Interventions
  1. Drug: Camidanlumab Tesirine
MeSH:Lymphoma Hodgkin Disease
HPO:Hodgkin lymphoma Lymphoma

Primary Outcomes

Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

Measure: Objective Response Rate (ORR)

Time: Up to 3 years

Secondary Outcomes

Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.

Measure: Duration of Response (DOR)

Time: Up to 3 years

Description: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.

Measure: Complete Response (CR) Rate

Time: Up to 3 years

Description: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.

Measure: Relapse-Free Survival (RFS)

Time: Up to 3 years

Description: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

Measure: Progression-Free Survival (PFS)

Time: Up to 3 years

Description: OS defined as the time from first dose of study drug until death due to any cause.

Measure: Overall Survival (OS)

Time: Up to 3 years

Measure: Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT)

Time: Up to 3 years

Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.

Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)

Time: Day 1 (post-dose) until 30 days after last dose of study drug

Description: An SAE is defined as any adverse event (AE) that: results in death. is life threatening. requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE). results in persistent or significant disability/incapacity. is a congenital anomaly/birth defect. important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE)

Time: Day 1 (post-dose) until 30 days after last dose of study drug

Description: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.

Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results

Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)

Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.

Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements

Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)

Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)

Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results

Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)

Measure: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Measure: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.

Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab Tesirine

Measure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses

Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug

Measure: Number of Participants With At Least One ADA Titer

Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug

Measure: Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine

Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug

Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.

Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.

Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.

Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
5 A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells And to Treat Systemic Inflammation Associated With COVID-19

This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.

NCT04148430
Conditions
  1. B Cell ALL
  2. B-Cell Lymphoma
  3. B-cell Non Hodgkin Lymphoma
Interventions
  1. Drug: Anakinra
MeSH:Lymphoma Lymphoma, B-Cell
HPO:B-cell lymphoma Lymphoma

Primary Outcomes

Description: Determine the rate of severe neurotoxicities, >/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells

Measure: Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities

Time: 4 weeks

Description: proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.

Measure: Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation

Time: 28 days from the start of treatment
6 Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique

The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20). The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma. Translated with www.DeepL.com/Translator (free version)

NCT04386512
Conditions
  1. COVID
  2. Lymphoma
MeSH:Lymphoma
HPO:Lymphoma

Primary Outcomes

Measure: mortality

Time: 2 months

Measure: transfer to ICU

Time: 2 months
7 National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

The 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.

NCT04391946
Conditions
  1. Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
Interventions
  1. Behavioral: Data registry
MeSH:Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Osteochondritis
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma

Primary Outcomes

Description: Hematological pathology Description

Measure: Prognostic factors for healing of COVID-19 infection

Time: Day 0

Secondary Outcomes

Description: 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 diagnosis

Description: Allow national epidemiological monitoring and regularly inform the hematology community.

Measure: national epidemiological monitoring

Time: through study completion, an average of 2 years
8 Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma

France was gradually affected by SARS-Cov-2 from January 2020; it evolved in an epidemic mode in March and April 20. During the 1st phase of the epidemic, more than 250 000 cases of Covid-19 have been confirmed in France resulting in the death of more than 30,000 patients. Mortality from infection varies greatly depending on the age of the affected individuals and their comorbidities including a history of cancer. We conducted a retrospective study in 89 patients with lymphoma and Covid-19 during the first phase of the epidemic and showed a 30-day mortality of 29%. Mortality was higher in patients over 70 years of age and in a situation of relapsed or refractory disease. Lymphoma-induced hypogammaglobulinemia and / or lymphopenia as well as chemotherapy and immunotherapy treatments are known to promote the development of infections in affected individuals. Among these, anti-CD20 monoclonal antibodies, widely prescribed to treat B-cell non-Hodgkin lymphomas (B-NHL) induce a rapid depletion of over 95% of mature CD20 + B cells. This can alter the production of antibodies, and the constitution of memory responses to a new pathogen. Also, B lymphocytes have a key immunomodulatory role in the control of viral infections. The specific immune response to SARS-CoV -2 and its evolution remain under characterization. Regardless of their neutralizing capacity, specific IgM appear 5 days after the onset of symptoms while IgG appear after 14 days. The immune response to SARS-CoV-2 also includes a T lymphocyte component, with an increase, among circulating lymphocytes, of activated CD8 and CD4 T lymphocytes. Data are still lacking on the specific response of CD4 and CD8 T lymphocytes against SARS-CoV-2, but these responses probably play a crucial role in virus clearance as well as in the immunopathology associated with SARS-CoV-2. Therapeutic depletion of B lymphocytes before acute infection may alter the generation of primary and functional responses. Therefore, a growing concern is whether patients with B-NHL who have acquired an infection with SARS-CoV-2 are protected against re-infection in the same way when they have or have not received anti-CD20 monoclonal antibodies. Analyzing the clinical and immunological evolution of Covid-19 in patients with B-NHL is useful to adapt the treatment recommendations in their regard according to the risk of severe form of Covid-19 . This is a multicenter, prospective study to determine whether treatment with monoclonal anti-CD20 antibodies in patients with B-cell NHL modifies the clinical and immunological course of Covid-19.

NCT04641806
Conditions
  1. B-cell Lymphoma
  2. Covid19
MeSH:Lymphoma Lymphoma, Non-Hodgkin
HPO:Lymphoma Non-Hodgkin lymphoma

Primary Outcomes

Description: Quantification of IgG anti-SARS-Cov-2 by ELISA.

Measure: Immunological response to SARS Cov2

Time: 6 months to one year ater Covid-19

Description: length(s) of stay(s) for Covid-19 in hospitalization and intensive care

Measure: Clinical evolution after Covid-19 diagnosis

Time: 6 months after Covid-19
9 A Phase II Study of Anti-PD-1 Antibody (Sintilimab) Plus Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Second-line Salvage Therapy in Patients With Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

This study evaluates the addition of Sintilimab to current 2nd line salvage therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation, patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and progression, death, intolerance and toxicity, withdrawal of informed consent, or other reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT will withdraw from this study and receive proper treatment based on investigator's decision.

NCT04659434
Conditions
  1. Diffuse Large B Cell Lymphoma
  2. Relapsed Diffuse Large B-Cell Lymphoma
  3. Refractory Diffuse Large B-Cell Lymphoma
Interventions
  1. Drug: Sintilimab
MeSH:Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse
HPO:B-cell lymphoma Lymphoma

Primary Outcomes

Description: Complete response rate after treated by Sintilimab and R-GemOx

Measure: Complete response rate

Time: 6 weeks after the last dose of the combination therapy (each cycle is 21 days)

Secondary Outcomes

Description: Overall response rate after treated by Sintilimab and R-GemOx

Measure: Over response rate (ORR)

Time: 6 weeks after the last dose of the combination therapy (each cycle is 21 days)

Description: from date of inclusion to date of progression, relapse, or death from any cause

Measure: Overall Survival (OS)

Time: 2 years

Description: All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0

Measure: Rate of grade 3 or 4 treatment related adverse effect

Time: Time Frame: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody (each cycle is 28 days)
10 A Prospective Study of Patients With B-Cell Hematologic Malignancies on Ibrutinib Therapy Who Are Infected With Coronavirus Disease 2019 (COVID-19)

This 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.

NCT04665115
Conditions
  1. Asymptomatic COVID-19 Infection Laboratory-Confirmed
  2. B-Cell Neoplasm
  3. Chronic Lymphocytic Leukemia
  4. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  5. Mantle Cell Lymphoma
  6. Marginal Zone Lymphoma
  7. Small Lymphocytic Lymphoma
  8. Symptomatic COVID-19 Infection Laboratory-Confirmed
  9. Waldenstrom Macroglobulinemia
Interventions
  1. Drug: Ibrutinib
  2. Other: Quality-of-Life Assessment
MeSH:Infection Communicable Diseases Laboratory Infection Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Waldenstrom Macroglobulinemia
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma Monoclonal immunoglobulin M proteinemia

Primary Outcomes

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 registration

Measure: Proportion of patients who require mechanical ventilation and/or die (Cohort 2)

Time: Up to 28 days after study entry

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: 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 days

Measure: Reasons for hospitalization (Cohort I)

Time: Up to 84 days

Measure: Mortality (Cohort II)

Time: Up to 84 days

Measure: Time to hospital discharge (Cohort II)

Time: Up to 84 days

Description: Will characterize and summarize the need for and duration of oxygen supplementation.

Measure: Intubation and oxygen supplementation (Cohort II)

Time: Up to 84 days

Measure: Incidence of "flare phenomena" (Cohort II)

Time: Up to 84 days

Description: 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 registration

Description: 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 days

Measure: Coagulopathy and thrombosis measures

Time: Up to 28 days

Description: 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 days

Description: 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 days

HPO Nodes


Reports

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.

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