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RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation.
PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.
- Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) bone marrow transplantation.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen.
- Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4. Patients receive pentostatin IV continuously on days -3 to -2 and undergo total body irradiation on day -1.
- Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3.
Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.
Masking: Open Label, Primary Purpose: Treatment
cyclosporine, methotrexate, methoxsalen, mycophenolate mofetil, pentostatin, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation
Aurora Presbyterian Hospital
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:21-0400
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation ther...
RATIONALE: Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Someti...
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy or chemotherapy used to kill cancer cells. Infusions of donor w...
OBJECTIVES: I. Determine the safety of cyclosporine and mycophenolate mofetil as a non-ablative conditioning and post-transplantation immunosuppression regimen in patients with primary T-c...
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