Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00049075
First received: November 12, 2002
Last updated: June 20, 2013
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: fludarabine phosphate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Enrollment: 128
Study Start Date: August 2002
Study Completion Date: December 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049075

  Show 34 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Ralph M. Meyer, MD, FRCPC Margaret and Charles Juravinski Cancer Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00049075     History of Changes
Other Study ID Numbers: CL2, CAN-NCIC-CL2, BRLX-304160, CDR0000257836
Study First Received: November 12, 2002
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014