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.
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): NCT01241786
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Anthony Mato, MD||Hackensack Meridian Health|