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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019370 |
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving rituximab and fludarabine works in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: rituximab Drug: fludarabine phosphate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Rituximab and Fludarabine Treatment of Chronic Lymphocytic Leukemia (CLL/SLL): DNA Microarray Gene Expression Analysis |
| Estimated Enrollment: | 105 |
| Study Start Date: | April 1998 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive rituximab IV over 2-8 hours on day 1 and fludarabine IV over 30 minutes on days 1-5 (days 2-6 of cycle 1 only). Treatment repeats every 28 days for up to 4-6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 and 6 months and then at 1 and 2 years.
PROJECTED ACCRUAL: Approximately 105 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Intermediate-risk disease
Stage I or II: Active disease, as evidenced by at least 1 of the following criteria:
High-risk disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Prior steroid therapy to control autoimmune hemolytic anemia or immune thrombocytopenia is allowed provided:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Clinical Trials Office - NCI - Center for Cancer Research 888-624-1937 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Patient Recruitment 1-888-NCI-1937 | |
| Study Chair: | Wyndham H. Wilson, MD, PhD | National Cancer Institute (NCI) |
More Information
| Responsible Party: | NCI - Center for Cancer Research ( Wyndham Hopkins Wilson ) |
| Study ID Numbers: | CDR0000065863, NCI-97-C-0178 |
| Study First Received: | July 11, 2001 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00019370 History of Changes |
| Health Authority: | Unspecified |
|
stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia |
contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
|
Antimetabolites Anti-Infective Agents Vidarabine Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Lymphoma Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Leukemia, B-Cell |