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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 is a Phase 2 study that has completed, run by Hackensack Meridian Health. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01723839
The ClinicalTrials.gov registry entry for NCT01723839 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hackensack Meridian Health, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide is the first listed.
NCT01723839 reports 0 study locations.
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.
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