Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262795

Enrollment

206

Registered

2005-12-07

Start date

2003-09-30

Completion date

2005-10-31

Last updated

2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Brief summary

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.

Detailed 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.

Interventions

DRUGFludarabine

Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles

DRUGChlorambucil

Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 79 Years

Healthy volunteers

Inclusion criteria

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

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026