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NCT01723839 · ClinicalTrials.gov registry record · Phase 2
Phase II Protocol for CLL With Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide
A Phase 2 study, sponsored by Hackensack Meridian Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01723839: Completed Phase 2 study, sponsored by Hackensack Meridian Health.
NCT01723839 is a Phase 2 study that has completed, run by Hackensack Meridian Health. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01723839, a Phase 2 study, has completed, sponsored by Hackensack Meridian Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
In previously-untreated subjects with CLL, fludarabine and rituximab with or without cyclophosphamide (FR or FCR) produces complete responses (CR) of 40-80%. The major complication of FCR has been grade 3/4 neutropenia which was reduced using a lower dose of fludarabine and cyclophosphamide (FCR-Lite) The objective of this study is to evaluate the minimal residual disease (MRD) complete response rate (using the 2008 IWCLL guidelines) after 4 cycles of FCR-Lite plus lenalidomide in subjects with previously untreated CLL. Lenalidomide is active in frontline treatment of CLL as well as in patients with refractory disease. MRD has been demonstrated to be a sensitive surrogate marker for progression-free survival. If patients are MRD negative complete responders (CR) they will stop at 4 cycles of FCR-Lite followed by the lenalidomide consolidation/maintenance arm of the study. If they have a MRD positive CR or partial response (PR) they will continue with 2 additional cycles of FCR-Lite plus lenalidomide followed by lenalidomide consolidation/maintenance. They will be re-tested for MRD after the 6th cycle of FCR-Lite and after 6 and 12 months of lenalidomide monotherapy If they have no response (NR) or progressive disease (PD) following 4 cycles of FCR-Lite plus lenalidomide they will be removed from the study.
Primary Outcome
Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients.
Interventions
- DRUG Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-02-22 |
| Est. Completion | 2021-06-08 |
| Phase | Phase 2 |
What the finished NCT01723839 record still lists
NCT01723839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide is the first listed.
NCT01723839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01723839 about?
NCT01723839 is a clinical study titled "Phase II Protocol for CLL With Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide". In previously-untreated subjects with CLL, fludarabine and rituximab with or without cyclophosphamide (FR or FCR) produces complete responses (CR) of 40-80%. The major complication of FCR has been grade 3/4 neutropenia which was reduced using a lower dose of fludarabine and cyclophosphamide (FCR-Lit...
What is the current status of trial NCT01723839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2012-02-22. Estimated completion is 2021-06-08.
What interventions are being tested in trial NCT01723839?
The interventions under investigation include: Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01723839?
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 NCT01723839's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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