Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies
This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells
OBJECTIVES:
I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or
without Rituximab in previously treated lymphoid malignancies (rituximab will only be
evaluated in CD20 positive malignancies).
II. To determine the efficacy of the above regimen. III. To determine the ability to proceed
to blood stem peripheral blood collection following the above regimens (the impact of above
regimen on stem cell reserve).
IV. To determine remission duration.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP I: CD20-NEGATIVE LYMPHOMAS
GROUP II: CD20-POSITIVE LYMPHOMAS
After completion of study treatment, patients are followed up at 3-4 weeks and then every 6
months for 5 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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