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

Celgene

Status and phase: Completed; Phase 2

Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia

Treatments: Drug: lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963105

CC-5013-CLL-009

2009-009836-54 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups

Lenalidomide 5 mg

Experimental group

Description:

Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Treatment:

Drug: lenalidomide

Lenalidomide 10 mg

Experimental group

Description:

Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Treatment:

Drug: lenalidomide

Lenalidomide 15 mg

Experimental group

Description:

Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Treatment:

Drug: lenalidomide