Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-center Trial
This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.
PRIMARY OBJECTIVES:
I. To assess the safety of donor lymphocyte infusion (DLI) as adoptive immunotherapy for
persistent or relapsed malignant diseases in patients after related or unrelated
nonmyeloablative transplantation.
SECONDARY OBJECTIVES:
I. To determine disease response, progression free and overall survival, chimerism, grade of
graft-versus-host disease (GVHD), and infections.
OUTLINE:
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo
restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant
GVHD develops and disease status worsens or after at least 8 weeks if disease status is
unchanged and persistent donor T-cells are documented.
After completion of study treatment, patients are followed up periodically.
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