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NCT01241734 · ClinicalTrials.gov registry record · Phase 1
Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL
A Phase 1 study, sponsored by Hackensack Meridian Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01241734: Completed Phase 1 study, sponsored by Hackensack Meridian Health.
NCT01241734 is a Phase 1 study that has completed, run by Hackensack Meridian Health. 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
NCT01241734, a Phase 1 study, has completed, sponsored by Hackensack Meridian Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival. Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.
Primary Outcome
Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only
Interventions
- DRUG Revlimid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-09-22 |
| Phase | Phase 1 |
What the finished NCT01241734 record still lists
NCT01241734 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 1 intervention - of which Revlimid is the first listed.
NCT01241734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01241734 about?
NCT01241734 is a clinical study titled "Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL". The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival. Hypothesis is t...
What is the current status of trial NCT01241734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-10. Estimated completion is 2015-09-22.
What interventions are being tested in trial NCT01241734?
The interventions under investigation include: Revlimid (DRUG).
Who is sponsoring clinical trial NCT01241734?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01241734'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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