Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
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|ClinicalTrials.gov Identifier: NCT00535873|
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : September 2, 2013
Last Update Posted : August 21, 2018
- To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.
- To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
|Condition or disease||Intervention/treatment||Phase|
|Leukemia CLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
- Overall Response Rate (ORR) [ Time Frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days) ]ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
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): NCT00535873
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, M.D.||M.D. Anderson Cancer Center|