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A Phase I/II Study of Bortezomib with Rituximab, Cyclophosphamide, and Prednisone in Patients with Relapsed/Refractory Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL)
[Protocol 05-103]
- Full Title :
- A PHASE II STUDY OF THE NOVEL PROTEASOME INHIBITOR BORTEZOMIB IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE AND PREDNISONE IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA
- Purpose :
The purpose of this study is to assess the effectiveness of the drug bortezomib in treating patients with relapsed or refractory indolent B-cell lymphoproliferative disorders or mantle cell lymphoma when it is combined with other drugs now being used to treat these diseases (rituximab, cyclophosphamide, and prednisone).
Bortezomib is a new drug that has been approved by the FDA for use in patients with a cancer of the bone marrow called multiple myeloma. This drug is thought to inhibit many proteins (known as proteasomes) that cancer cells need to survive and multiply.
In the phase I portion of this study, researchers will determine the highest dose of bortezomib and cyclophosphamide that can be given to these patients. In the phase II portion, they will determine how active this combination of drugs is in treating the various kinds of lymphoma.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of chronic lymphocytic leukemia/B-cell small lymphocytic lymphoma, any marginal zone lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia, or mantle cell lymphoma.
- Patients must have received at least one but no more than three prior regimens of conventional chemotherapy. At least 4 weeks must have passed since prior treatment and entry into the study (6 weeks for BCNU or mitomycin C). Patients must have recovered from the side effects of all prior therapies.
- Patients must not have received any therapeutic monoclonal antibodies (such as rituximab, tositumomab, ibritumomab, or alemtuzumab) within 3 months of study entry (except for patients enrolled on the phase I portion, who may have received rituximab up to 7 days before). Patients who have been treated with monoclonal antibodies within 3 months may be enrolled if their disease continues to grow while on this therapy, as long as they have not received the treatment within 7 days of entering the study.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. John Gerecitano at 212-639-3748.
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