Overview

This trial is active, not recruiting.

Condition relapsed or refractory chronic lymphocytic leukemia
Treatment lenalidomide
Phase phase 2
Sponsor Celgene Corporation
Start date October 2009
End date September 2017
Trial size 104 participants
Trial identifier NCT00963105, CC-5013-CLL-009

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
lenalidomide
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
(Active Comparator)
Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
lenalidomide
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
(Active Comparator)
Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
lenalidomide
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

Primary Outcomes

Measure
Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide]
time frame: up to 55 months

Secondary Outcomes

Measure
Response rate (RR); International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL
time frame: up to 55 months
Duration of response (DOR)
time frame: up to 55 months
Time to response (TTR)
time frame: up to 55 months
Time to progression (TTP)
time frame: up to 55 months
Event-Free survival (EFS)
time frame: up to 55 months
Progression Free survival (PFS)
time frame: up to 55 months
Overall Survival (OS)
time frame: up to 55 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.