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NCT06644183 · ClinicalTrials.gov registry record · Phase 1
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study of Leukemia and Chronic Lymphocytic Leukemia, sponsored by Jennifer R. Brown, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT06644183: Recruiting Phase 1 study of Leukemia and Chronic Lymphocytic Leukemia, sponsored by Jennifer R. Brown, MD, PhD.
NCT06644183 is a Phase 1 study of Leukemia and Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Jennifer R. Brown, MD, PhD. The registered enrollment target is 64 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06644183, a Phase 1 study of Leukemia and Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Jennifer R. Brown, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). The names of the study drugs involved in this study are: * Roginolisib (a novel type of PI3-kinase delta inhibitor) * Venetoclax (a type of B-cell lymphoma 2 inhibitor) * Rituximab (a type of monoclonal antibody)
Primary Outcome
uMRD rate is defined as the proportion of participants with uMRD after treatment with either roginolisib plus venetoclax + rituximab, or venetoclax+ rituximab, as measured in bone marrow at a level of 10-4 by the clonoSEQ assay.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Roginolisib
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2025-03-19 |
| Est. Completion | 2032-10-01 |
| Phase | Phase 1 |
What NCT06644183 shows while recruiting
NCT06644183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06644183 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06644183 about?
NCT06644183 is a clinical study titled "Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)". This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). The names of the study drugs involved in this study are: * Roginolisib (a nov...
What is the current status of trial NCT06644183?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2025-03-19. Estimated completion is 2032-10-01.
What conditions does trial NCT06644183 study?
This clinical trial studies the following conditions: Leukemia, Chronic Lymphocytic Leukemia, Relapsed Cancer, Refractory Leukemia, Relapsed Leukemia.
What interventions are being tested in trial NCT06644183?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), Roginolisib (DRUG).
Who is sponsoring clinical trial NCT06644183?
This trial is sponsored by Jennifer R. Brown, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06644183 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06644183's enrollment target sits among peer trials
64 95th of 233 higher than 139 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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