A Phase I/II Study of Sequential Chemoradiation Followed by Autologous Stem Cell Transplant in Patients with Untreated Advanced Mantle Cell Lymphoma

Protocol
11-095
Full Title
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients with Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial
Phase
I/II
Disease Status
Newly Diagnosed
Purpose

Mantle cell lymphoma (MCL) is a rare and aggressive type of cancer which can be difficult to treat successfully. Standard therapy for MCL includes R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) which can be given in combination with high-dose chemotherapy and an autologous stem cell transplant (ASCT, in which some of a patient’s stem cells are removed before chemotherapy, multiplied outside the body, and returned to the patient to help re-establish the patient’s immune system).

In this study, researchers are evaluating a combination of four treatments in patients newly diagnosed with MCL: R-CHOP, followed by R-HIDAC (rituximab plus cytarabine), then radioimmunotherapy (RIT) with radioactively labeled tositumumab, and finally ASCT.

In the phase I portion of the study, investigators will determine the highest dose of cytarabine which can be given safely in patients with MCL. In the phase II portion, they will evaluate the effectiveness of the four-part treatment regimen. Cytarabine is a drug that has been used for decades to treat leukemia and other hematologic cancers.

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 advanced-staged MCL that has not yet been treated.
  • Patients must be between the ages of 18 and 70.

For more information and to inquire about eligibility for this study, please contact Dr. Andrew Zelenetz at 212-639-2656.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
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