Study Examining the Combination of Lenalidomide and Azacitidine for Relapsed/Refractory CLL and SLL
|ClinicalTrials.gov Identifier: NCT01241786|
Recruitment Status : Terminated (anticipated results not seen and population not seen)
First Posted : November 16, 2010
Last Update Posted : November 8, 2012
To determine the response to the combination of azacitidine + lenalidomide in patients with relapsed/refractory CLL and SLL
Hypothesize - lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)||Drug: Revlimid Drug: Azacitidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single Arm Study Examining the Combination of Lenalidomide and Azacitidine (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
- Drug: Revlimid
Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and < 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21).Other Name: Lenalidomide
- Drug: Azacitidine
Azacitidine 75 mg/m2 IV or SC D 1-5Other Name: Vidaza
- The primary objective of this study is to estimate the rate of response, using International Working Group response criteria, to the combination of azacitidine + lenalidomide in patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).
- 1. Assess for treatment related toxicity following administration of lenalidomide/ azacitidine.
- 2. Estimate the progression free survival and overall survival of patients treated with the combination of lenalidomide and azacitidine
- 3. Bank tumor samples for planned correlative analyses to identify epigenetically silenced, clinically relevant genes in CLL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241786
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Anthony Mato, MD||Hackensack University Medical Center|