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NCT02815397 · ClinicalTrials.gov registry record · Phase 2
DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma
A Phase 2 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02815397: Clinical Trial Phase 2 study, sponsored by Rush University Medical Center.
NCT02815397 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02815397, a Phase 2 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1 week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after last cycle of chemo-immunotherapy. DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given intrathecally each cycle to patients deemed appropriate by treating physician). Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease will go on to salvage therapy off study.
Primary Outcome
Progression-free survival determined by CT scans at 18 months
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Why NCT02815397 stopped before completion
NCT02815397 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT02815397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02815397 about?
NCT02815397 is a clinical study titled "DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma". Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1 week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after last cycle of chemo-immunotherapy. DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given...
What is the current status of trial NCT02815397?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2016-02. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02815397?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT02815397?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02815397's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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