Spots Global Cancer Trial Database for Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
Official Title: A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Study ID: NCT00049075
Conditions
Interventions
Study Description
Brief 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.
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
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Providence Health Care - Vancouver, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Algoma Reginal Cancer Program at Sault Area Hospital, Sault Sainte Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital - Weston, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Hopital de L'Enfant Jesus, Quebec City, Quebec, Canada
Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Centre Jean Bernard, Le Mans, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Contact Details
Name: Ralph M. Meyer, MD, FRCPC
Affiliation: Margaret and Charles Juravinski Cancer Centre
Role: STUDY_CHAIR
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