Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1269 | Data registry Wiki | 0.58 |
| drug2036 | IMU-838 Wiki | 0.41 |
| drug4640 | Venetoclax Wiki | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007945 | Leukemia, Lymphoid NIH | 0.77 |
| D010007 | Osteochondritis NIH | 0.58 |
| D008258 | Waldenstrom Macroglobulinemia NIH | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005550 | Chronic lymphatic leukemia HPO | 1.00 |
| HP:0005526 | Lymphoid leukemia HPO | 0.77 |
| HP:0005508 | Monoclonal immunoglobulin M proteinemia HPO | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002665 | Lymphoma HPO | 0.55 |
| HP:0001909 | Leukemia HPO | 0.41 |
Navigate: Correlations HPO
There are 3 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.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.
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 yearsThis 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