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A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation for Relapsed Follicular Lymphoma
[Protocol 07-085]
- Full Title :
- A PHASE II STUDY OF GM-CSF (SARGRAMOSTIM) AND RITUXIMAB FOLLOWING AUTOLOGOUS TRANSPLANTATION FOR RELAPSED FOLLICULAR LYMPHOMA
- Purpose :
This study is being done to see if doctors can improve the treatment of follicular lymphoma that either persists despite treatment or has returned shortly after treatment is completed. Treatment usually puts follicular lymphoma into remission, but the cancer usually returns. When this happens, a treatment called "high-dose chemotherapy with autologous stem cell transplantation" (ASCT) can put the cancer into remission again for a long time. However, ASCT is not able to kill all of the lymphoma, and a small amount of cells usually remain. Over time, these cells grow, and the lymphoma can be seen again on imaging tests.
One way to try to make remissions last longer is to give more treatment after ASCT to kill any remaining lymphoma cells. But this approach can cause many side effects. It is easier to give antibodies after ASCT, which generally have fewer side effects than chemotherapy. Antibodies can kill cancer cells by attaching to proteins called antigens on the cells. An antibody called rituximab is specially designed to react with an antigen on some lymphoma cells called CD20.
Rituximab works by attaching to lymphoma cells and to cells known as monocytes. This attachment allows the monocytes to be close to and then kill the lymphoma cells. GM-CSF is a protein made by the body that makes monocytes work better. Doctors think that GM-CSF might make monocytes and rituximab work better to kill lymphoma cells.
The purpose of this research is to see how long remissions will last if patients with follicular lymphoma receive GM-CSF and rituximab together after ASCT.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have grade 1, 2, or 3 follicular lymphoma that persists or has returned despite prior therapy.
- Patients may have had up to three prior regimens of antilymphoma therapy.
- Patients may not have had prior autologous or allogeneic hematopoietic stem cell transplantation.
- Patients must be between the ages of 18 and 70.
For more information and to inquire about eligibility for this study, please contact Dr. Craig Moskowitz at 212-639-2696.
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