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D008258: Waldenstrom Macroglobulinemia

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

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug3154 Standard of care treatment Wiki 0.71
drug1566 Ibrutinib Wiki 0.58
drug2672 Quality-of-Life Assessment Wiki 0.38
Name (Synonyms) Correlation
drug1262 Favipiravir Wiki 0.21
drug2448 Placebo Wiki 0.05

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D007945 Leukemia, Lymphoid NIH 0.71
D020522 Lymphoma, Mantle-Cell NIH 0.71
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.58
Name (Synonyms) Correlation
D007938 Leukemia, NIH 0.50
D008223 Lymphoma, NIH 0.41
D003141 Communicable Diseases NIH 0.07
D007239 Infection NIH 0.05

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 1.00
HP:0005526 Lymphoid leukemia HPO 0.71
HP:0005550 Chronic lymphatic leukemia HPO 0.71
Name (Synonyms) Correlation
HP:0002665 Lymphoma HPO 0.45
HP:0001909 Leukemia HPO 0.32

Clinical Trials

Navigate: Correlations   HPO

There is one clinical trial.


1 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


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials

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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