NCT01241786

Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL

A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine) in patients with relapsed/refractory CLL and SLL Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

Detailed description

Treatment response of lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

Conditions

• Chronic Lymphocytic Leukemia(CLL)
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
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).
DRUG	Azacitidine	Azacitidine 75 mg/m2 IV or SC D 1-5

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-11-16
• Last updated: 2022-07-20
• Results posted: 2022-07-20

Locations

1 site across 1 country: United States