Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Celgene104 enrolled

Overview

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

lenalidomideDRUG

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows: * Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years at the time of signing the informed consent form * Must be able to adhere to the study visit schedule and other protocol requirements * Must have a documented diagnosis of B-cell CLL * Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen * Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Active infections requiring systemic antibiotics * Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment * Alemtuzumab therapy within 120 days of initiating lenalidomide treatment * Prior therapy with lenalidomide * History of grade 4 rash due to prior thalidomide treatment * Planned autologous or allogeneic bone marrow transplantation * Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. * Uncontrolled hyperthyroidism or hypothyroidism * Venous thromboembolism within 12 months * ≥ Grade 2 neuropathy * Uncontrolled autoimmune hemolytic anemia or thrombocytopenia * Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\] * Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy

Locations (52)

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events

Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.

Time frame: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.

Secondary Outcomes

Overall Response Rate (ORR)

ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils \>1.5 x 10\^9/L, platelets \>100 x 10\^9/L, hemoglobin (hgb) \>11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils \>1.5 x 10\^9/ or ≥50% increase, platelets \>100 x 10\^9/L or ≥50% increase, hgb 11 g/dL.

Time frame: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

Kaplan-Meier Estimate of Duration of Response

Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.

Data from ClinicalTrials.gov

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UCSD Moores Cancer Center

La Jolla, California, United States

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, United States

Stanford University School of Medicine

Stanford, California, United States

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Cancer and Blood Disease Center

Lecanto, Florida, United States

Northwestern University Medical Center Division of Hematology Oncology

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

...and 42 more locations