Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00049075|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 28, 2016
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 or disease||Intervention/treatment||Phase|
|Leukemia||Drug: fludarabine phosphate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date :||August 2002|
|Primary Completion Date :||July 2005|
|Study Completion Date :||December 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049075
Hide Study Locations
|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|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|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|
|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|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|St. Joseph's Health Centre - Toronto|
|Toronto, Ontario, Canada, M6R 1B5|
|Humber River Regional Hospital - Weston|
|Weston, Ontario, Canada, M9N 1N8|
|Cancer Care Ontario - Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|Fleurimont, Quebec, Canada, J1H 5N4|
|Hopital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Montreal, Quebec, Canada, H1T 2M4|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L 4MI|
|Montreal, Quebec, Canada, H2W 1S6|
|Hopital de L'Enfant Jesus|
|Quebec City, Quebec, Canada, G1J 1Z4|
|Hopital du Saint-Sacrement, Quebec|
|Quebec City, Quebec, Canada, G1S 4L8|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Study Chair:||Ralph M. Meyer, MD, FRCPC||Margaret and Charles Juravinski Cancer Centre|