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A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia


Phase 2
16 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia


OBJECTIVES:

- Determine the overall response rate (complete and partial) in patients with previously
untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine.

- Determine the molecular complete response rate in patients who achieve a clinical or
immunophenotypic complete response when treated with this drug.

- Determine the progression-free and treatment-free survival of patients treated with
this drug.

- Determine the toxicity of this drug in these patients.

- Determine the baseline incidence of defined genetic abnormalities in patients treated
with this drug.

- Determine the prognostic and predictive significance of defined genetic abnormalities
in patients with respect to response to treatment with this drug.

- Determine the prognostic and predictive significance of immunophenotypic profile of
patients with respect to response to treatment with this drug.

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.

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ralph M. Meyer, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre

Authority:

United States: Federal Government

Study ID:

CL2

NCT ID:

NCT00049075

Start Date:

August 2002

Completion Date:

December 2009

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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