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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053027 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with cladribine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine works in treating patients with newly-diagnosed mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: cladribine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL) |
Study Start Date: | February 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable toxicity during the first course, the study is discontinued; otherwise, the study is opened for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of 5/14/04.)
Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study within 21 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or assessable disease defined as at least one of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study ID Numbers: | CDR0000269055, NCCTG-N0189 |
Study First Received: | January 27, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00053027 History of Changes |
Health Authority: | United States: Federal Government |
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Cladribine Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Mantle-Cell Mantle Cell Lymphoma Immunosuppressive Agents |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma 2-chloro-3'-deoxyadenosine |
Cladribine Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Rituximab Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |