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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 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 2 participants.
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.
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02815397
The ClinicalTrials.gov registry entry for NCT02815397 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT02815397 reports 0 study locations.
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.
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