This trial is active, not recruiting.

Condition b-cell chronic lymphocytic leukemia (b-cll)
Treatments lenalidomide, chlorambucil
Phase phase 3
Sponsor Celgene Corporation
Start date October 2009
End date March 2018
Trial size 450 participants
Trial identifier NCT00910910, 2008-003079-32, CC-5013-CLL-008


The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
1 - Lenalidomide
lenalidomide Revlimid
For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first. For patients with moderate renal impairment (defined as CrCl ≥ 30 to < 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.
(Active Comparator)
2- Chlorambucil
chlorambucil Leukeran
Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Primary Outcomes

Progression Free Survival (PFS)
time frame: Every 28 days
Safety [type, frequency, and severity of adverse events (AEs)]
time frame: Up to 105 months; every 28 days
Overall Survival
time frame: Up to 105 months
Number of anti-cancer therapies obtained from randomized participants
time frame: Up to 105 months

Secondary Outcomes

Response, including evaluation of minimal residual disease (MRD) by flow cytometry (Hallek, 2008)
time frame: Every 28 days
Duration of response
time frame: Every 28 days
Time to response
time frame: Every 28 days
Health-Related Quality of Life (HRQL) by Functional Assessment of Cancer Therapy -Leukemia (FACT-Leu) and EQ-5D
time frame: Every 8 weeks

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. Must sign an informed consent form. 2. Age ≥ 65 years 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Must have a documented diagnosis of B-cell CLL. 5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2. 6. Must agree to follow pregnancy precautions as required by the protocol. 7. Must agree to receive counseling related to teratogenic and other risks of lenalidomide. 8. Must agree not to donate blood or semen as defined by the protocol Exclusion Criteria: 1. Prior treatment for B-cell CLL. 2. Any medical condition, that would prevent the subject from signing the informed consent form. 3. Active infections requiring systemic antibiotics. 4. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide 5. Pregnant or lactating females. 6. Participation in any clinical study or having taken any investigational therapy within 28 days. 7. Known presence of alcohol and/or drug abuse. 8. Central nervous system (CNS) involvement. 9. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) 10. History of renal failure requiring dialysis. 11. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection. 12. Prior therapy with lenalidomide. 13. Evidence of TLS at screening 14. Presence of specific hematology and/or chemistry abnormalities 15. Uncontrolled hyperthyroidism or hypothyroidism 16. Venous thromboembolism within one year 17. ≥ Grade-2 neuropathy 18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia 19. Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]

Additional Information

Description After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. No specific causality for this imbalance has been identified to date. Investigators were instructed to immediately discontinue all participants from experimental lenalidomide treatment and inform their patients accordingly. Participants on the Chlorambucil arm may continue up to 12 months (13 cycles) with the last participant completing in March 2014. All randomized participants will continue to be followed for overall survival and secondary primary malignancies.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.