Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	Other, Pharmaceutical / Industry	CAN-NCIC-CL2 BRLX-304160, NCT00049075, CL2

Objectives

1. Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine.
2. Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug.
3. Determine the progression-free and treatment-free survival of patients treated with this drug.
4. Determine the toxicity of this drug in these patients.
5. Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug.
6. Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug.
7. Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug.

Entry 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/mm³
  • 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

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

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

Expected Enrollment

A total of 120 patients will be accrued for this study within 2 years.

Outline

This is a multicenter study.

Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy.

Patients are followed at 2 months and then every 4 months for 2 years.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Ralph Meyer, MD, FRCPC, Protocol chair		Ph: 905-387-9495 Email: rmeyer@ctg.queens.ca

Registry Information
Official Title		A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Trial Start Date		2002-08-08
Registered in ClinicalTrials.gov		NCT00049075
Date Submitted to PDQ		2002-09-05
Information Last Verified		2003-12-15

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