Phase II Protocol for CLL With Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide (FCR)
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|ClinicalTrials.gov Identifier: NCT01723839|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2012
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia (CLL)||Drug: Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide||Phase 2|
The primary objective is to evaluate the complete response rate following 4 cycles of FCR-Lite plus lenalidomide in previously untreated patients with CLL.
The first secondary objective is to evaluate the toxicity of patients with previously untreated CLL treated with FCR-Lite plus lenalidomide, followed by lenalidomide. The second is to evaluate the overall response rate and overall survival of patients with previously untreated CLL treated with FCR-Lite plus lenalidomide followed by lenalidomide. The third is to determine whether adding lenalidomide as a consolidation/maintenance therapy will eliminate bone marrow minimal residual disease in CR patients and whether patients who have a PR after 6 cycles of FCR-Lite plus lenalidomide will respond to 12 months of lenalidomide. The final secondary objective is to determine whether the expression of ZAP-70, CD38, and chromosomes correlate with response rate, duration of response, and survival for previously untreated patients with CLL.
2-stage phase 2 study-design. 19 subjects are treated in stage-1 with FCR-Lite plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs the study will accrue an additional 35 subjects (see statistical section). A secondary objective of this study will be to determine if MRD positive patients will become MRD negative with lenalidomide consolidation/maintenance and whether PR patients will convert to CRs Lenalidomide will begin 2 months after the last dose of FCR-Lite in all subjects with CR. It may begin as soon as 1 month after FCR-Lite plus lenalidomide in subjects with PR. Lenalidomide is given in 28 d cycles increasing the dose from 5 mg/d to 10 mg/d in cycle 2 and to 15mg in cycles 3-6 if well- tolerated (no grade-3 or -4 toxicity). Patients with creatinine clearance ≥30ml/min and <60ml/min will start at 2.5mg daily increasing to 5 and 10mg in subsequent cycles . Reduction to the prior dose is allowed for grade-3/-4 toxicity. MRD will be studied by flow cytometry from bone marrow and peripheral blood samples following 4 and 6 cycles of FCR-Lite and after 6 and 12 months of lenalidomide in CR patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated CLL With Four or Six Cycles of Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide Followed by Lenalidomide Consolidation/ Maintenance|
|Actual Study Start Date :||February 22, 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
FCR with Lenalidomide
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Drug: Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide
19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
Other Name: FCR + Lenalidomide
- Complete Response [ Time Frame: 28 day cycle ]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. Ninety-five percent confidence intervals for the true CR will be calculated
- Overall Response Rate [ Time Frame: 4-6 28 day cycles ]Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated. Responses will be evaluated after 4 and 6 cycles of FCR plus lenalidomide and after 6 and 12 cycles of lenalidomide consolidation/maintenance. The overall survival (OS) is defined as the time interval between the treatment starting date and the documented date of death. For a surviving patient, OS is censored at the last follow-up date when the patient is documented to be alive. Progression-free survival (PFS) is defined as the time interval between the treatment starting date and the documented date of disease progression or death, whichever occurs first. For an alive and progression free patient, PFS is censored at the last follow-up date when patient is documented to be progression free.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723839
|United States, New Jersey|
|John Theurer Cancer Center at HackensackUMC|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Andre Goy, MD||John Theurer Cancer Center at HackensackUMC|