Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab
|ClinicalTrials.gov Identifier: NCT00609869|
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : September 1, 2014
Last Update Posted : September 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphocytic Leukemia Mantle Cell Lymphoma||Drug: Lenalidomide Drug: Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide (REVLIMID®) in Combination With Rituximab for Patients With CD5+/CD20+ Hematologic Malignancies Who Relapse or Progress After Rituximab|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2015|
Experimental: Lenalidomide and Rituximab
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.
Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.
Other Name: REVLIMID®Drug: Rituximab
Rituximab was administered at 375 mg/m^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.
Other Name: RITUXAN®
- Overall Response Rate (ORR) [ Time Frame: Up to 6 years ]The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.
- Clinical Benefit Rate [ Time Frame: Up to 6 years ]The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.
- Median Time to Treatment Failure (TTF) [ Time Frame: Up to 6 years ]The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609869
|United States, Florida|
|Center for Cancer Care & Research/Watson|
|Lakeland, Florida, United States, 33805|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Javier Pinilla, M.D., PhD.||H. Lee Moffitt Cancer Center and Research Institute|