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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049075

  Hide Study Locations
Locations
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre
Kitchner, Ontario, Canada, N2G 1G3
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Algoma Reginal Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, Canada, P6B 1Y5
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Humber River Regional Hospital - Weston
Weston, Ontario, Canada, M9N 1N8
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital de L'Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
France
Centre Jean Bernard
Le Mans, France, 72000
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Fludarabine phosphate
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014