Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia
NCT ID: NCT00086775
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-07-31
2009-10-31
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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alemtuzumab
rituximab
fludarabine phosphate
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Principal Investigators
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Ann S. LaCasce, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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CDR0000365631
Identifier Type: REGISTRY
Identifier Source: secondary_id
BRLX-STA1-03-058
Identifier Type: -
Identifier Source: secondary_id
OHSU-HEM-03050-P
Identifier Type: -
Identifier Source: secondary_id
DMS-F0334
Identifier Type: -
Identifier Source: secondary_id
BRLX-FLUCAM106
Identifier Type: -
Identifier Source: org_study_id