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    HP:0005550: Chronic lymphatic leukemia

    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 (6)


    Name (Synonyms) Correlation
    drug1269 Data registry Wiki 0.58
    drug2036 IMU-838 Wiki 0.41
    drug4640 Venetoclax Wiki 0.33
    Name (Synonyms) Correlation
    drug2055 Ibrutinib Wiki 0.29
    drug3484 Quality-of-Life Assessment Wiki 0.22
    drug2995 Oseltamivir Wiki 0.22

    Correlated MeSH Terms (9)


    Name (Synonyms) Correlation
    D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 1.00
    D007945 Leukemia, Lymphoid NIH 0.77
    D010007 Osteochondritis NIH 0.58
    Name (Synonyms) Correlation
    D008258 Waldenstrom Macroglobulinemia NIH 0.58
    D007938 Leukemia, NIH 0.55
    D008223 Lymphoma, NIH 0.55
    D020522 Lymphoma, Mantle-Cell NIH 0.41
    D003141 Communicable Diseases NIH 0.04
    D007239 Infection NIH 0.03

    Correlated HPO Terms (4)


    Name (Synonyms) Correlation
    HP:0005526 Lymphoid leukemia HPO 0.77
    HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 0.58
    HP:0002665 Lymphoma HPO 0.55
    Name (Synonyms) Correlation
    HP:0001909 Leukemia HPO 0.41

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 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 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
    3 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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