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

NCT ID: NCT01241786

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

response to Vidaza + Revlimid

response to combination of azacitidine + lenalidomide 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)

Group Type: EXPERIMENTAL

Revlimid

Intervention Type: DRUG

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).

Azacitidine

Intervention Type: DRUG

Azacitidine 75 mg/m2 IV or SC D 1-5

Interventions

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).

Intervention Type: DRUG

Azacitidine

Azacitidine 75 mg/m2 IV or SC D 1-5

Intervention Type: DRUG

Other Intervention Names

Lenalidomide; Vidaza

Eligibility Criteria

Inclusion Criteria

Patients must be age ≥ 18 must have an ECOG PS ≤ 2 must understand and voluntarily sign informed consent adhere to the study protocol requirements and schedule must carry the diagnosis of B-CLL/SLL, SLL/CLL must be defined as relapsed or refractory disease Pts. must have received and failed at least one purine-based treatment regimen (ie. FCR, FR, PCR, Fludarabine) or alemtuzumab-based regimen or bendamustine-based regimen prior to study enrollment Serum bilirubin levels <1.5 times the upper limit of the normal range for the laboratory (ULN) Higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis or Gilbert's disease.Serum (SGOT) [AST])(SGPT) [ALT]) levels <2 x ULN or <5 x ULN if hepatic metastases are present) Subjects must have calculated creatinine clearance ≥ 30ml/min Absolute neutrophil count > 1.0 x 109 / L Platelet count > 50x 109 / L (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast All participants must be registered into the mandatory RevAssist® program Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Mato, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

Pro00001361

Identifier Type: -

Identifier Source: org_study_id