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Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Laboratory Biomarker Analysis
Lenalidomide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria

    • Must have high-risk B-CLL as defined by ≥ one of the following:

      • High-risk cytogenetics (either 17p deletion and/or 11q deletion)
      • Unmutated immunoglobulin heavy chain gene rearrangement
    • Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
  • No prior treatment for the management of B-CLL
  • Patients must have B-CLL requiring therapy as defined by the IWCLL criteria

  • Must have measurable disease meeting one of the following criteria:

    • Absolute lymphocyte count > 5,000/μL
    • Measurable lymphadenopathy or organomegaly

  • No tumor lysis syndrome (TLS) by Cairo-Bishop definition

    • Patients with correction of electrolyte abnormalities allowed
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)

  • Uric acid normal

    • Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
  • Able to adhere to the study visit schedule and other protocol requirements
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
  • No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • No known hypersensitivity to thalidomide or lenalidomide
  • No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
  • No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years
  • No cardiac arrest within the past 6 months
  • No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
  • No other concurrent anti-cancer agents or treatments
  • More than 28 days since any prior experimental drug or therapy
  • Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
  • No prior lenalidomide

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

Maximal clinical response (complete and partial response)
Summarized by a sample proportion along with the exact 95% confidence interval. The time-to-progression will be graphically analyzed using standard Kaplan-Meier estimation.

Full Information

First Posted
January 5, 2011
Last Updated
June 3, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01271283
Brief Title
Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia
Official Title
Lenalidomide for the Treatment of CLL Patients With High-Risk Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the time to progression in patients with high-risk chronic lymphocytic leukemia (CLL) treated with lenalidomide. SECONDARY OBJECTIVES: I. To determine the clinical response (complete and partial response) in treatment-naïve patients with high-risk CLL treated with single-agent lenalidomide. II. To determine the incidence of immune-mediated flare reaction. III. To determine the toxicity profile of single-agent lenalidomide in previously untreated patients with high-risk CLL. IV. To conduct correlative studies in bone marrow, peripheral blood, and/or lymph nodes of patients treated with lenalidomide. OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies. After completion of study therapy, patients are followed up every 3 months for a maximum of 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.
Intervention Type
Other
Intervention Name(s)
Diagnostic Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, CC5013, CDC 501, Revlimid
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Maximal clinical response (complete and partial response)
Description
Summarized by a sample proportion along with the exact 95% confidence interval. The time-to-progression will be graphically analyzed using standard Kaplan-Meier estimation.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria Must have high-risk B-CLL as defined by ≥ one of the following: High-risk cytogenetics (either 17p deletion and/or 11q deletion) Unmutated immunoglobulin heavy chain gene rearrangement Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial No prior treatment for the management of B-CLL Patients must have B-CLL requiring therapy as defined by the IWCLL criteria Must have measurable disease meeting one of the following criteria: Absolute lymphocyte count > 5,000/μL Measurable lymphadenopathy or organomegaly No tumor lysis syndrome (TLS) by Cairo-Bishop definition Patients with correction of electrolyte abnormalities allowed ECOG performance status 0-2 ANC ≥ 1,500/mm³ Platelet count ≥ 75,000/mm³ Creatinine clearance ≥ 30 mL/min Total bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present) Uric acid normal Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures Not pregnant or nursing Negative pregnancy test Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide Able to adhere to the study visit schedule and other protocol requirements No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study No known hypersensitivity to thalidomide or lenalidomide No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years No cardiac arrest within the past 6 months No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody No other concurrent anti-cancer agents or treatments More than 28 days since any prior experimental drug or therapy Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required No prior lenalidomide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Chanan-Khan
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

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