Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2007-07-01
• 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 regimen of chemotherapy is more effective for chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: Leukemia Research Fund
• Collaborator: Medical Research Council
• Treatments: Chlorambucil; Cyclophosphamide; Doxorubicin; Fludarabine; Fludarabine phosphate; Liposomal doxorubicin; Prednisolone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting the following criteria:

• Previously untreated disease

• Peripheral blood morphology, excluding other leukemia and low-grade lymphoma in leukemic phase

• Cell markers: CD5+, CD23+, SmIg (weak), CD79b-, FMC7-

• Persistent lymphocytosis (greater than 10,000/mm^3)

• At least 40% bone marrow infiltration

• Stage 0 or I progressive disease indicated by at least one of the following:

• Persistent rise in lymphocyte count with doubling time less than 12 months

• Downward trend in hemoglobin and/or platelet count

• At least 50% increase in size of liver and/or spleen and/or lymph nodes

• Appearance of lymphadenopathy, hepatomegaly, or splenomegaly

• Constitutional symptoms caused by disease

• Pyrexia

• Night sweats

• Weight loss OR

• Stage II or III

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)*

• SGOT/SGPT no greater than 2 times ULN* NOTE: * Unless due to CLL

Renal:

• Creatinine clearance at least 30 mL/min

Other:

• No other cancer or life-threatening disease

• Not pregnant

• Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No concurrent corticosteroids (e.g., dexamethasone) as antiemetics

Radiotherapy

• Not specified

Surgery

• Not specified