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NCT02049541 · ClinicalTrials.gov registry record · Phase 1
Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma
A Phase 1 study, sponsored by Kami Maddocks, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02049541: Completed Phase 1 study, sponsored by Kami Maddocks, MD.
NCT02049541 is a Phase 1 study that has completed, run by Kami Maddocks, MD. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02049541, a Phase 1 study, has completed, sponsored by Kami Maddocks, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase I clinical trial studies the side effects and the best dose of phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab may be an effective treatment for B-cell lymphoma.
Primary Outcome
Summarized and tabulated by dose level.
Interventions
- BIOLOGICAL rituximab
- OTHER Correlative studies
- DRUG PI3K inhibitor BKM120
- OTHER Pharmacodynamics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2019-04-09 |
| Phase | Phase 1 |
What the finished NCT02049541 record still lists
NCT02049541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which rituximab is the first listed.
NCT02049541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02049541 about?
NCT02049541 is a clinical study titled "Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma". This phase I clinical trial studies the side effects and the best dose of phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor BKM120 may stop the growth of cancer cells by ...
What is the current status of trial NCT02049541?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-07-21. Estimated completion is 2019-04-09.
What interventions are being tested in trial NCT02049541?
The interventions under investigation include: rituximab (BIOLOGICAL), Correlative studies (OTHER), PI3K inhibitor BKM120 (DRUG), Pharmacodynamics (OTHER).
Who is sponsoring clinical trial NCT02049541?
This trial is sponsored by Kami Maddocks, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02049541's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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