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Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy


OBJECTIVES:

Primary

- Compare the complete response rate in patients with refractory or relapsed B-cell
chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine
and rituximab.

Secondary

- Compare the overall response rate in patients treated with these regimens.

- Compare 1-year survival of patients treated with these regimens.

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

- Compare duration of response in patients treated with these regimens.

- Compare the adverse event profile of these regimens in these patients.

- Compare the molecular response rate in patients treated with these regimens.

- Compare lymphocyte and lymphocyte subset recovery (CD3, CD3/CD4, CD3/CD8, CD20) in
patients treated with these regimens.

- Compare the time to complete response in patients treated with these regimens.

- Compare the rate of cytomegalovirus reactivation and time to reactivation in patients
treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to prior treatment with fludarabine (yes vs no). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. At least 30 minutes
before fludarabine administration, patients receive alemtuzumab subcutaneously (SC) on
days 1-5.

- Arm II: Patients receive fludarabine as in arm I. At least 30 minutes before
fludarabine administration, patients receive rituximab IV on days 1 and 4 of course 1
and on day 1 only in subsequent courses.

In both arms, treatment repeats every 28 days for 4-6 courses in the absence of disease
progression or unacceptable toxicity. An interim assessment is performed during course 4.
Patients achieving a partial response or stable disease receive 2 additional courses of
therapy (for a total of 6 courses). Patients achieving a complete response (CR) do not
receive further treatment beyond CR.

Patients are followed weekly for 2 months, monthly for 6 months, every 2 months for 6
months, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as:

- Peripheral lymphocyte count > 5,000/mm^3

- Clonal CD5-, CD19-, and CD23-positive lymphocytes

- Refractory to OR relapsed after prior first-line therapy

- No CNS involvement with CLL

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

Renal

- Creatinine ≤ 1.5 times ULN

Immunologic

- No active cytomegalovirus

- No prior fludarabine-associated autoimmune hemolytic anemia or immune
thrombocytopenic purpura

- No active infection requiring treatment with antibiotic, antiviral, or antifungal
agents

- No prior significant allergic reaction to antibody therapies that required therapy to
be discontinued

- HIV negative

Other

- No active secondary malignancy

- No other concurrent severe diseases or mental disorders

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior alemtuzumab and/or rituximab

- No prior bone marrow transplantation

- No concurrent thrombopoietin or pegfilgrastim

Chemotherapy

- More than 3 weeks since prior fludarabine

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 3 months since prior investigational drugs

- No other concurrent cytotoxic therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ann S. LaCasce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000365631

NCT ID:

NCT00086775

Start Date:

July 2003

Completion Date:

Related Keywords:

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

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Jackson Oncology Associates, PLLCJackson, Mississippi  39202