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NCT04578600 · ClinicalTrials.gov registry record · Phase 1
CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma
A Phase 1 study, sponsored by Joseph Tuscano.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04578600: Completed Phase 1 study, sponsored by Joseph Tuscano.
NCT04578600 is a Phase 1 study that has completed, run by Joseph Tuscano. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04578600, a Phase 1 study, has completed, sponsored by Joseph Tuscano.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase I/Ib trial investigates the side effects of CC-486 and how well it works in combination with lenalidomide and obinutuzumab in treating patients with CD20 positive B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Chemotherapy drugs, such as CC-486, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide is a drug that alters the immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Obinutuzumab is a type of antibody therapy that targets and attaches to the CD20 proteins found on follicular lymphoma cells as well as some healthy blood cells. Once attached to the CD20 protein the obinutuzumab is thought to work in different ways, including by helping the immune system destroy the cancer cells and by destroying the cancer cells directly. Giving CC-486 with lenalidomide and obinutuzumab may improve response rates, quality, and duration, and minimize adverse events in patients with B-cell lymphoma.
Primary Outcome
Safety summaries will include tabulations in the form of tables and listings. The frequency (number and percentage) of treatment-emergent AEs will be reported. The frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions will be reported. Additional AE summaries will include AE frequency by AE severity and by relationship to study drug. Toxicity data by type and severity will be summarized by frequency tables. Per-treated analysis will be performed to includ
Interventions
- DRUG Lenalidomide
- BIOLOGICAL Obinutuzumab
- DRUG Oral Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2025-02-21 |
| Phase | Phase 1 |
What the finished NCT04578600 record still lists
NCT04578600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.
NCT04578600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04578600 about?
NCT04578600 is a clinical study titled "CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma". This phase I/Ib trial investigates the side effects of CC-486 and how well it works in combination with lenalidomide and obinutuzumab in treating patients with CD20 positive B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Chemotherapy drugs, such as CC-...
What is the current status of trial NCT04578600?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-10-23. Estimated completion is 2025-02-21.
What interventions are being tested in trial NCT04578600?
The interventions under investigation include: Lenalidomide (DRUG), Obinutuzumab (BIOLOGICAL), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04578600?
This trial is sponsored by Joseph Tuscano, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04578600's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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