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NCT03986034 · ClinicalTrials.gov registry record · Phase 2
Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study of Chronic Lymphocytic Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT03986034: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03986034 is a Phase 2 study of Chronic Lymphocytic Leukemia that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 75 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03986034, a Phase 2 study of Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The drug venetoclax treats chronic lymphocytic leukemia (CLL). Researchers want to find better treatments for CLL. To do that, they need to learn how the drug affects CLL cancer cells and the immune system. Objective: To learn about genetic changes that happen during treatment of CLL with venetoclax. Eligibility: Adults ages 18 and older with relapsed or refractory CLL after at least 1 prior therapy Design: Participants will be screened under a separate protocol. In Phase 1, participants will get venetoclax free of charge through the NIH. Venetoclax is started at a low dose. The dose will be increased every week until participants reach their maximum tolerable dose. This usually take about 5 weeks. Participants will visit the NIH at least once per week. Visits will be about 4 hours. They may have to stay in the hospital to be observed. In Phase 2, participants will continue to get the drug through their local cancer doctor and their health insurance. Patients will also visit the NIH every 6 months, or if their disease progresses. At the NIH participants will have regular health assessments. These will include physical exams and a review of the medicines they are taking. They will talk about how they are feeling. The study included the following tests: Blood draws CT scans: Participants will lie in a machine that takes pictures of the body (maximum 3 per year) Bone marrow biopsies: A small amount of marrow will be taken out of the participant s hip bone with a needle. Optional lymph node biopsies: A small piece of the participant s tissue will be taken out with a needle. The study will last at least 2 years.
Primary Outcome
The planned analyses will include descriptive statistics on the proportions of clonal shift probability during the venetoclax ramp-up phase. The clonal shift probabilities will be estimated using the sample proportions and their inferences including confidence intervals and hypotheses testing will be evaluated
Conditions Studied
Interventions
- DRUG During Venetoclax
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2026-07-03 |
| Phase | Phase 2 |
What NCT03986034 shows while recruiting
NCT03986034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which During Venetoclax is the first listed.
NCT03986034 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03986034 about?
NCT03986034 is a clinical study titled "Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)". Background: The drug venetoclax treats chronic lymphocytic leukemia (CLL). Researchers want to find better treatments for CLL. To do that, they need to learn how the drug affects CLL cancer cells and the immune system. Objective: To learn about genetic changes that happen during treatment of CLL ...
What is the current status of trial NCT03986034?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2019-06-26. Estimated completion is 2026-07-03.
What conditions does trial NCT03986034 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT03986034?
The interventions under investigation include: During Venetoclax (DRUG).
Who is sponsoring clinical trial NCT03986034?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03986034 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03986034's enrollment target sits among peer trials
75 77th of 187 higher than 111 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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