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A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study Of The Efficacy & Safety Of Lenalidomide (Revlimid®) Vs. Chlorambucil As First-Line Therapy For Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia

Phase 3
65 Years
Open (Enrolling)
B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study Of The Efficacy & Safety Of Lenalidomide (Revlimid®) Vs. Chlorambucil As First-Line Therapy For Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia

CC-5013-CLL-008 is a Phase 3, multi-center, randomized, open-label, parallel-group study
that will compare the efficacy and safety of oral lenalidomide to that of oral chlorambucil
in elderly patients with previously untreated B-cell CLL. Eligible patients must not have
received any treatment for their B-cell CLL, must be symptomatic, and must be ≥ 65 years of

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Every 28 days

Safety Issue:


Principal Investigator

Oliver Kong, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

February 2018

Related Keywords:

  • B-Cell Chronic Lymphocytic Leukemia (B-CLL)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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