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

German CLL Study Group

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Chlorambucil; Drug: Fludarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00262795

EU-20557

CLL5

MEDAC-GCLLSG-CLL5

GCLLSG-73

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 65 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

F

Experimental group

Description:

Fludarabine

Treatment:

Drug: Fludarabine

CLB

Active Comparator group

Description:

Chlorambucil

Treatment:

Drug: Chlorambucil