Trial Information

S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)

Primary objective:

- Determine whether allogeneic peripheral blood stem cell transplantation with
pre-conditioning low dose total body irradiation and fludarabine followed by
cyclosporine and mycophenolate mofetil, when given to elderly patients with acute
myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of
survival 1 year after transplantation) to warrant a phase III investigation.

Secondary objective:

- Determine the frequency and severity of toxic effects of this regimen in these
patients.

Other objectives as funding permits:

- Determine whether chimerism patterns in bone marrow and blood after transplantation are
associated with relapse and/or graft-versus-host disease (GVHD) in these patients.

- Determine whether cytogenic, immunophenotypic, and molecular biologic features detected
in pre- and post-transplantation specimens are related to transplant outcomes and risk
of relapse in these patients.

OUTLINE: This is an open-label study.

- Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2.
Patients also undergo total body irradiation on day 0.

- Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim
transplantation (G-CSF)-mobilized donor PBSC on day 0.

- Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3
to 35 followed by a taper until day 180. Patients also receive oral mycophenolate
mofetil on day 0 to 27 without tapering.

- Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30
minutes for up to 2 infusions.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.