Lymphoma Clinical Trial
Official title:
A Phase I/II Study of the Safety and Feasibility of REVM10 or REVM10/ANTISENSE POL 1 Transduced Hematopoietic Stem Cells (HSC) in HIV-1 Related Non-Hodgkin's Lymphoma Patients Already Being Treated With High Dose Chemotherapy and Peripheral Blood Stem Cell Support
RATIONALE: Inserting the gene for RevM10 into a person's peripheral stem cells may improve
the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of RevM10-treated stem cells plus
chemotherapy and peripheral stem cell transplantation in treating patients who have
HIV-related non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the safety of infusion of RevM10 or RevM10/polAS transduced
hematopoietic stem cells (HSC) in addition to high dose chemotherapy and standard peripheral
blood stem cell support in patients with HIV-1 related non-Hodgkin's lymphoma. II. Determine
gene marking of lymphocytes and myeloid cells in peripheral blood, bone marrow, and/or lymph
nodes after infusion of RevM10-HSC or RevM10/polAS-HSC in these patients. III. Determine the
antiretroviral effect of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive mobilization therapy and undergo
leukapheresis according to a standard protocol. High dose chemotherapy is administered on
days -7 to -1, also according to a standard protocol. On day 0, autologous hematopoietic
stem cells transduced with genes RevM10 or RevM10/polAS are infused. Unmodified autologous
peripheral blood stem cells are reinfused on day 1. Patients are followed daily for 2 weeks,
weekly for 2 weeks, monthly for 1 year, then annually thereafter.
PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 14
months.
;
Primary Purpose: Treatment
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