VZCLLPI0146: Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Terminated
CT.gov ID
NCT01241786
Collaborator
Celgene Corporation (Industry)
5
1
1
13
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

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 Names:
  • Lenalidomide
  • Drug: Azacitidine
    Azacitidine 75 mg/m2 IV or SC D 1-5
    Other Names:
  • Vidaza
  • Outcome Measures

    Primary Outcome Measures

    1. the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients [9 Months]

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

    Secondary Outcome Measures

    1. Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine. [30 days after treatment completion (up to 10 Months)]

    2. The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine [9 Months]

    3. The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine [9 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Exclusion Criteria: - Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would places the subject at unacceptable risk or confound the interpretation of data from the study Patients must be lenalidomide / azacitidine naïve prior to study enrollment Patients must not be HIV, Hepatitis B or Hepatitis C positive, except for Patients who are seropositive because of hepatitis B virus vaccine are eligible Patients must not have received chemotherapy, immunotherapy or any experimental study drug for CLL or SLL at least 4 weeks prior to study enrollment and initiation of treatment Patients with history of B-CLL and the development of prolymphocytic leukemia or Richter's transformation Known or suspected hypersensitivity to azacitidine, mannitol, thalidomide or Lenalidomide Pregnant or breast feeding females are not eligible or lactating females must agree not to breast feed while taking Lenalidomide Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome Subjects may be enrolled upon correction of electrolyte abnormalities Patients with advanced malignant hepatic tumors; Concurrent use of other anti-cancer agents or treatments, or Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health
    • Celgene Corporation

    Investigators

    • Principal Investigator: Anthony Mato, MD, Hackensack Meridian Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT01241786
    Other Study ID Numbers:
    • Pro00001361
    First Posted:
    Nov 16, 2010
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jun 1, 2022

    Study Results

    Participant Flow

    Recruitment Details A total of five subject participated in the trial.
    Pre-assignment Detail A total of five patients were screened and consented for study and scheduled to start cycle 1
    Arm/Group Title Revlimid (Lenalidomide)and Vidaza (Azacitidine)
    Arm/Group Description Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL.
    Period Title: Overall Study
    STARTED 5
    COMPLETED 0
    NOT COMPLETED 5

    Baseline Characteristics

    Arm/Group Title Revlamid + Vidaza
    Arm/Group Description The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question.
    Overall Participants 5
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    1
    20%
    >=65 years
    4
    80%
    Sex: Female, Male (Count of Participants)
    Female
    2
    40%
    Male
    3
    60%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    20%
    Not Hispanic or Latino
    4
    80%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    4
    80%
    More than one race
    0
    0%
    Unknown or Not Reported
    1
    20%

    Outcome Measures

    1. Primary Outcome
    Title the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients
    Description the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).
    Time Frame 9 Months

    Outcome Measure Data

    Analysis Population Description
    Zero patients achieved a response to the combination
    Arm/Group Title Study Terminated
    Arm/Group Description Study terminated - closed early
    Measure Participants 5
    Number [participants]
    0
    0%
    2. Secondary Outcome
    Title Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine.
    Description
    Time Frame 30 days after treatment completion (up to 10 Months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Revlamid + Vidaza
    Arm/Group Description The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question.
    Measure Participants 5
    Number [participants]
    1
    20%
    3. Secondary Outcome
    Title The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine
    Description
    Time Frame 9 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Revlamid + Vidaza
    Arm/Group Description The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question.
    Measure Participants 4
    Median (Full Range) [Months]
    1
    4. Secondary Outcome
    Title The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine
    Description
    Time Frame 9 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Revlamid + Vidaza
    Arm/Group Description The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question.
    Measure Participants 5
    Number [participants]
    5
    100%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Revlimid + Vidaza
    Arm/Group 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). Other Names: Lenalidomide Drug: Azacitidine Azacitidine 75 mg/m2 IV or SC D 1-5 Other Names: Vidaza
    All Cause Mortality
    Revlimid + Vidaza
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Revlimid + Vidaza
    Affected / at Risk (%) # Events
    Total 2/5 (40%)
    Investigations
    Disease Progression 1/5 (20%) 1
    Musculoskeletal and connective tissue disorders
    Pelvic Pain 1/5 (20%) 1
    Nervous system disorders
    Syncope 1/5 (20%) 1
    Other (Not Including Serious) Adverse Events
    Revlimid + Vidaza
    Affected / at Risk (%) # Events
    Total 0/5 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Anthony Mato
    Organization Hackensack University Medical Center
    Phone 551-996-2000
    Email AMato@hackensackumc.org
    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT01241786
    Other Study ID Numbers:
    • Pro00001361
    First Posted:
    Nov 16, 2010
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jun 1, 2022