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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049075 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)
Persistent lymphocytosis of greater than 5,000/mm^3
Monoclonal B-cell population
No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No history of other malignancies except for the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids except inhaled or topical corticosteroids
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| 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 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Cancer Care Ontario - Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| 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 | |
| Grand River Regional Cancer Centre | |
| Kitchner, Ontario, Canada, N2G 1G3 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Humber River Regional Hospital - Weston | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Algoma Reginal Cancer Program at Sault Area Hospital | |
| Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| 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 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4MI | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hopital de L'Enfant Jesus | |
| Quebec City, Quebec, Canada, G1J 1Z4 | |
| Hopital du Saint-Sacrement, Quebec | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| France | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Study Chair: | Ralph M. Meyer, MD, FRCPC | Margaret and Charles Juravinski Cancer Centre |
More Information
| Study ID Numbers: | CDR0000257836, CAN-NCIC-CL2, BRLX-304160 |
| Study First Received: | November 12, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00049075 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Vidarabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs |
Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |