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CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)


OBJECTIVES:

Primary

- Determine the best cytostatic response rate (including complete response, partial
response, or stable disease) in patients with relapsed or refractory chronic
lymphocytic leukemia treated with lenalidomide (CC-5013).

Secondary

- Determine the cytostatic response rate in patients who progress on CC-5013 and are then
treated with CC-5013 and rituximab.

- Determine the safety of these regimens in these patients.

- Determine time to progression in patients treated with these regimens.

OUTLINE: This is an open-label, non-randomized, pilot study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond
CR.

Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab
IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry

- Relapsed or refractory disease

- Measurable disease, defined by 1 of the following criteria:

- Absolute lymphocyte count ≥ 5,000/mm^3

- Measurable lymphadenopathy or organomegaly

- Received ≥ 1 prior therapy for CLL

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 30,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases
are present)

Renal

- Creatinine ≤ 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method (including barrier) contraception
during and for 3 months after study participation

- No known hypersensitivity to thalidomide

- No erythema nodosum characterized by a desquamating rash after prior thalidomide or
similar drug administration

- No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins

- No serious medical condition or laboratory abnormality that would preclude study
participation

- No psychiatric illness that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior lenalidomide (CC-5013)

- No concurrent thalidomide

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since prior therapy for CLL

- At least 28 days since prior experimental drug or therapy

- No other concurrent anticancer therapies

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Kelvin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000391767

NCT ID:

NCT00096044

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263