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Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01271283
First received: January 5, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Drug: lenalidomide
Other: diagnostic laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lenalidomide for the Treatment of CLL Patients With High-Risk Disease

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Time Frame: From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal clinical response (complete and partial response) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: December 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Drug: lenalidomide
Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Other: diagnostic laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271283

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Investigators
Principal Investigator: Asher Chanan-Khan Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01271283     History of Changes
Other Study ID Numbers: NCI-2011-02568, NCI-2011-02568, CDR0000692070, RPCI # I 174910, 8254
Study First Received: January 5, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014