Trial Information

A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma

OBJECTIVES:

- 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
intravenously (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.