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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049075 |
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.
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
Study Chair: | Ralph M. Meyer, MD, FRCPC | Margaret and Charles Juravinski Cancer Centre |
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 Leukemia, Lymphoid Vidarabine Immunoproliferative Disorders Immunologic Factors Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents |
Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic |
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 |