Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which chlorambucil regimen is more effective in treating advanced chronic lymphocytic leukemia.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Chlorambucil; Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell chronic lymphocytic leukemia

• Co-expression of CD5/CD19 or CD5/CD20 positivity, dim sIg, and CD23 positivity

• Previously untreated advanced disease defined as presence of at least 1 of the following:

• Total tumor mass (TTM) score greater than 9

• TTM doubling time less than 12 months

• Bone marrow failure (platelet count less than 100,000/mm^3 and/or hemoglobin less than 10 g/dL)

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin less than 3 times upper limit of normal (ULN)

• Hepatitis B negative

• No active hepatitis C

Renal:

• Creatinine less than 3 times ULN OR

• Creatinine clearance greater than 0.5 times normal

Cardiovascular:

• No severe cardiovascular disease

• No arrhythmia requiring chronic treatment

• No New York Heart Association class III or IV congestive heart failure

• No symptomatic ischemic heart disease

Other:

• No uncontrolled systemic infection

• HIV negative

• No prior or concurrent uncontrolled malignancy

• No prior or concurrent central nervous system or psychiatric disorders requiring hospitalization

• No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior steroid therapy for less than 2 weeks allowed

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified