This trial is active, not recruiting.

Condition leukemia
Treatments chlorambucil, fludarabine phosphate
Phase phase 3
Sponsor German CLL Study Group
Start date September 2003
Trial size 205 participants
Trial identifier NCT00262795, CDR0000455042, EU-20557, GCLLSG-73, GCLLSG-CLL5, MEDAC-GCLLSG-CLL5


RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants from 65 years up to 79 years old.

DISEASE CHARACTERISTICS: - Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria: - Binet stage A with B symptoms - Binet stage B or C, meeting 1 of the following criteria: - Rapid disease progression - Enlarged lymph nodes and organs - Severe B symptoms - Previously untreated disease PATIENT CHARACTERISTICS: Performance status - ECOG 0-2 Life expectancy - More than 6 months Hematopoietic - No thrombocytopenia - No autoimmune hemolytic anemia Hepatic - Not specified Renal - Not specified Other - No severe organ dysfunction - No other prior or concurrent neoplasm PRIOR CONCURRENT THERAPY: Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy

Additional Information

Official title Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
Description OBJECTIVES: Primary - Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil. - Compare the duration of remission in patients treated with these regimens. Secondary - Compare the incidence of toxicity, especially infections, in patients treated with these regimens. - Compare the quality of life in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses. - Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months. PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).