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| Sponsor: | Pharmatech Oncology |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026351 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: rituximab Drug: pentostatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkin's Lymphoma (NHL) Including Chronic Lymphocytic Leukemia (CLL) |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs is administered on days 36, 43, and 50. Patients with progressive disease or a complete response receive no further treatment. Patients with responsive disease, but less than a complete response, receive one additional course of therapy as above.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed low-grade non-Hodgkin's lymphoma
REAL classification:
International Working Group classification:
Small lymphocytic/chronic lymphocytic leukemia (CLL)
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| Cancer and Blood Institute of the Desert | |
| Rancho Mirage, California, United States, 92270 | |
| Redding Medical Center | |
| Redding, California, United States, 96001 | |
| United States, Maryland | |
| Oncology-Hematology Associates, P.A. | |
| Clinton, Maryland, United States, 20735 | |
| United States, New York | |
| Hematology Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13210 | |
| North Shore Hematology/Oncology Associates, P.C. | |
| East Setauket, New York, United States, 11733 | |
| Study Chair: | Judy Poehlman | Pharmatech Oncology |
More Information
| Study ID Numbers: | CDR0000069021, PHARMATECH-N007, PHARMATECH-20001631, SUPERGEN-PHARMATECH-N007 |
| Study First Received: | November 9, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026351 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma prolymphocytic leukemia contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage I marginal zone lymphoma |
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Leukemia, Lymphoid Pentostatin Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Enzyme Inhibitors |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Antirheumatic Agents Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |