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D015451: Leukemia, Lymphocytic, Chronic, B-Cell

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 (8)

Name (Synonyms) Correlation
drug1001 Data registry Wiki 0.58
drug1289 Famotidine 20 MG Wiki 0.41
drug1034 Diagnostic Laboratory Biomarker Analysis Wiki 0.41
Name (Synonyms) Correlation
drug1165 Electronic Health Record Review Wiki 0.41
drug1601 Ibrutinib Wiki 0.33
drug463 Biospecimen Collection Wiki 0.29
drug2717 Quality-of-Life Assessment Wiki 0.22
drug2732 Questionnaire Administration Wiki 0.17

Correlated MeSH Terms (12)

Name (Synonyms) Correlation
D007938 Leukemia, NIH 0.87
D007945 Leukemia, Lymphoid NIH 0.82
D008223 Lymphoma, NIH 0.71
Name (Synonyms) Correlation
D010007 Osteochondritis NIH 0.58
D008258 Waldenstrom Macroglobulinemia NIH 0.58
D009190 Myelodysplastic Syndromes NIH 0.41
D020522 Lymphoma, Mantle-Cell NIH 0.41
D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.41
D009196 Myeloproliferative Disorders NIH 0.33
D009369 Neoplasms, NIH 0.11
D003141 Communicable Diseases NIH 0.04
D007239 Infection NIH 0.03

Correlated HPO Terms (5)

Name (Synonyms) Correlation
HP:0005526 Lymphoid leukemia HPO 0.82
HP:0005550 Chronic lymphatic leukemia HPO 0.82
HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 0.58
Name (Synonyms) Correlation
HP:0002665 Lymphoma HPO 0.52
HP:0001909 Leukemia HPO 0.37

Clinical Trials

Navigate: Correlations   HPO

There are 3 clinical trials

1 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.

  1. Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
  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
2 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.

  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
  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
3 Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer

This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.

  1. Accelerated Phase CML, BCR-ABL1 Positive
  2. Acute Lymphoblastic Leukemia
  3. Acute Myeloid Leukemia
  4. Chronic Lymphocytic Leukemia
  5. Chronic Phase CML, BCR-ABL1 Positive
  6. COVID-19 Infection
  7. Hematopoietic and Lymphoid Cell Neoplasm
  8. Hodgkin Lymphoma
  9. Lymphoblastic Lymphoma
  10. Myelodysplastic Syndrome
  11. Myelofibrosis
  12. Myeloproliferative Neoplasm
  13. Non-Hodgkin
  14. Non-Hodgkin Lymphoma
  1. Procedure: Biospecimen Collection
  2. Other: Diagnostic Laboratory Biomarker Analysis
  3. Other: Electronic Health Record Review
  4. Other: Questionnaire Administration
MeSH:Lymphoma Leukemia Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Myelodysplastic Syndromes Myeloproliferative Disorders
HPO:Chronic lymphatic leukemia Leukemia Lymphoma Myelodysplasia Myeloproliferative disorder Neoplasm

Primary Outcomes

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.

Measure: Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels

Time: Up to 180 days post-hematopoietic stem cell transplant (HCT)

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

Measure: SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels

Time: Up to 180 days post-HCT

Description: Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.

Measure: SARS-CoV-2 neutralizing antibodies

Time: Up to 180 days post-HCT

Secondary Outcomes

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA.

Measure: SARS-CoV-2 IgA concentration

Time: Up to 180 days post-HCT

Other Outcomes

Description: The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S or SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

Measure: SARS-CoV-2 -specific T cell memory profile and associated function

Time: Up to 180 days post-HCT

HPO Nodes


Data processed on January 01, 2021.

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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