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NCT00783367 · ClinicalTrials.gov registry record · Phase 2
Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas
A Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00783367: Completed Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT00783367 is a Phase 2 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00783367, a Phase 2 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Pre-clinical data and recently published clinical data suggest a synergistic effect between lenalidomide and dexamethasone. We hypothesize that a combination of lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being treated with rituximab alone or with a rituximab-containing regimen, we propose initial treatment with both drugs for two 28-day treatment cycles (Part I). After response assessment following two cycles of lenalidomide-dexamethasone, patients will enter Part II of the study. In Part II, patients will receive lenalidomide-dexamethasone and rituximab to evaluate the potential reversal of rituximab resistance as measured by response to rituximab and progression-free survival following rituximab.
Primary Outcome
Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).
Interventions
- DRUG Rituximab
- DRUG Dexamethasone
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-07 |
| Est. Completion | 2020-11-23 |
| Phase | Phase 2 |
What the finished NCT00783367 record still lists
NCT00783367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT00783367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00783367 about?
NCT00783367 is a clinical study titled "Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas". Pre-clinical data and recently published clinical data suggest a synergistic effect between lenalidomide and dexamethasone. We hypothesize that a combination of lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate to lenalidomide and dexamethasone plus rituxim...
What is the current status of trial NCT00783367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-07. Estimated completion is 2020-11-23.
What interventions are being tested in trial NCT00783367?
The interventions under investigation include: Rituximab (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00783367?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00783367's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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