Completed

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

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What is being tested

Data Collection

Who is being recruted

Chronic Disease
+11

+ Hematologic Diseases
+ Immune System Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2003
See protocol details

Summary

Principal SponsorBayer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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 
NCT00086775
Principal SponsorBayer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Disease Attributes
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, United StatesSee the location
Suspended
Jackson Oncology Associates, PLLCJackson, United States
Suspended
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, United States
Suspended
Western Pennsylvania Cancer InstitutePittsburgh, United States

Completed5 Study Centers
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