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

NCT01241786 | Terminated Phase 2 Results DMC

• 1 other identifier: Pro00001361
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia(CLL); Small Lymphocytic Lymphoma

Keywords

chronic lymphocytic leukemia (CLL); Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients

  the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).

  9 Months

Secondary Outcomes (3)

• Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine.

  30 days after treatment completion (up to 10 Months)

• The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine

  9 Months

• The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine

  9 Months

Study Arms (1)

response to Vidaza + Revlimid

EXPERIMENTAL

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)

Drug: Revlimid; Drug: Azacitidine

Interventions

Revlimid 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).

Also known as: Lenalidomide

response to Vidaza + Revlimid

Azacitidine DRUG

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

Also known as: Vidaza

response to Vidaza + Revlimid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Celgene Corporation: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Five patients were screened, consented and started cycle 1 but all patients were removed from study due to non response. The study was closed early due to poor accrual on 8/17/2011 before completing the timeframe required for statistical analysis.

Results Point of Contact

• Title: Dr. Anthony Mato
• Organization: Hackensack University Medical Center

AMato@hackensackumc.org

551-996-2000

Study Officials

• Anthony Mato, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-06

Locations

US (1)