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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003746 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cladribine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia |
Estimated Enrollment: | 120 |
Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident.
Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Switzerland | |
Inselspital Bern | |
Bern, Switzerland, CH-3010 |
Study Chair: | Reinhard Zenhaeusern, MD | University Hospital Inselspital, Berne |
Study ID Numbers: | CDR0000066865, SWS-SAKK-32/98, EU-98074 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003746 History of Changes |
Health Authority: | United States: Federal Government |
untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia |
Cladribine Lymphatic Diseases Leukemia Leukemia, Hairy Cell Prolymphocytic Leukemia Immunoproliferative Disorders |
Leukemia, Prolymphocytic Immunologic Factors Hairy Cell Leukemia Lymphoproliferative Disorders Immunosuppressive Agents |
Cladribine Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Leukemia Lymphatic Diseases Leukemia, Hairy Cell Neoplasms Therapeutic Uses Lymphoproliferative Disorders |