Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2009-12-21
• 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.

PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

• Previously untreated

• Rai stage I, II, III, or IV

• Requiring systemic therapy

• Persistent lymphocytosis of greater than 5,000/mm^3

• Morphologically mature lymphocytes

• Monoclonal B-cell population

• CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping

• No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome

• No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia

• Positive Coomb's test allowed if no clinical hemolysis

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• See Disease Characteristics

Hepatic

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

• AST and/or ALT no greater than 2 times ULN

Renal

• Creatinine no greater than 2 times ULN

Other

• Accessible for treatment and follow-up

• No known HIV infection

• No active bacterial, viral, or fungal infection requiring systemic antibiotics

• No conditions requiring corticosteroid therapy

• No history of other malignancies except for the following:

• Adequately treated nonmelanoma skin cancer

• Curatively treated carcinoma in situ of the cervix

• Other solid tumors curatively treated with no evidence of disease within the past 5 years

• No other major medical illness that would preclude study

• No known hypersensitivity to fludarabine or its components

• Not pregnant or nursing

• Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy including monoclonal antibody therapy

• No concurrent autologous or allogeneic stem cell or bone marrow transplantation

Chemotherapy

• No other concurrent cytotoxic drugs

Endocrine therapy

• No concurrent corticosteroids except inhaled or topical corticosteroids

• No concurrent corticosteroids for nausea prophylaxis

Radiotherapy

• No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area

• No concurrent radiotherapy

Surgery

• Not specified

Other

• At least 4 weeks since prior investigational agents

• No other concurrent investigational agents