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NCT04722601 · ClinicalTrials.gov registry record · Phase 1
A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma
A Phase 1 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04722601: Clinical Trial Phase 1 study, sponsored by University of Chicago.
NCT04722601 is a Phase 1 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722601, a Phase 1 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study focuses on finding a safe and tolerable dose for a three-drug regimen that combines venetoclax (Venclexta Ⓡ), CC-486 (also known as oral azacitidine) and obinutuzumab (Gazyva Ⓡ) to treat cancer participants who have minimally pretreated follicular lymphoma and have experienced disease progression despite trying previous cancer therapies. If a safe and tolerable drug dose can be found in the first phase of the study, doctors leading the study will launch a second phase of the study within an expansion cohort. Participants in this expansion cohort will receive the dose established in the first phase of the study to determine the efficacy of the regimen/ established dose. Participants in the expansion cohort will also receive the same study drugs from the first phase of the study, but in a different order/combination (first pairing the two oral drugs, CC-486 and venetoclax, then adding the third drug, obinutuzumab to treatment). The end goal of this research is to establish a new chemotherapy-sparing treatment option for patients with follicular lymphoma that is just as effective (or better) than current standard of care options.
Primary Outcome
The maximum tolerated dose of venetoclax and CC-486 in patients with minimally pre-treated follicular lymphoma. Doctors leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") according to the NCI Common Terminology Criteria (CTCAE) for Adverse Events Version 5.
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG CC-486
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
Why NCT04722601 stopped before completion
NCT04722601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT04722601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04722601 about?
NCT04722601 is a clinical study titled "A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma". This study focuses on finding a safe and tolerable dose for a three-drug regimen that combines venetoclax (Venclexta Ⓡ), CC-486 (also known as oral azacitidine) and obinutuzumab (Gazyva Ⓡ) to treat cancer participants who have minimally pretreated follicular lymphoma and have experienced disease pro...
What is the current status of trial NCT04722601?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-09-01. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT04722601?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), CC-486 (DRUG).
Who is sponsoring clinical trial NCT04722601?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04722601's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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