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NCT03045328 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL
A Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by Steven E. Coutre.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT03045328: Completed Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by Steven E. Coutre.
NCT03045328 is a Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia that has completed, run by Steven E. Coutre. The registered enrollment target is 22 participants, below the 48-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03045328, a Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, has completed, sponsored by Steven E. Coutre.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label non-randomized two-center phase 2 study evaluating the safety and efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or refractory CLL/SLL.
Primary Outcome
Complete Response (CR) will be assessed as the number of participants who, based on investigator assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, achieve a complete remission. IWCLL complete remission is defined as follows. * Lymphadenopathy: none \> 1.5 cm * Blood lymphocytes: \< 4,000/µL * Hepatomegaly: none * Splenomegaly: none * Bone marrow: normocellular with \< 30 lymphocytes, no B lymphoid nodules. The outcome is reported as the number of
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Ibrutinib
Study Locations (2)
California
- City of Hope - Duarte
- Stanford University, School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2021-08-05 |
| Phase | Phase 2 |
What the finished NCT03045328 record still lists
NCT03045328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 48-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (54% lower).
The record links to 4 conditions, with Recurrent Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT03045328 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03045328 about?
NCT03045328 is a clinical study titled "Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL". This is an open-label non-randomized two-center phase 2 study evaluating the safety and efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or refractory CLL/SLL.
What is the current status of trial NCT03045328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2017-09-26. Estimated completion is 2021-08-05.
What conditions does trial NCT03045328 study?
This clinical trial studies the following conditions: Recurrent Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT03045328?
The interventions under investigation include: Venetoclax (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03045328?
This trial is sponsored by Steven E. Coutre, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03045328 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03045328's enrollment target sits among peer trials
22 13th of 20 higher than 8 of 20 other Recurrent Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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