Phase II Trial of T-Cell Depleted Hematopoietic Stem Cell Transplants (SBA-E-BM) From HLA Compatible Related or Unrelated Donors After a Myeloablative Preparative Regimen of Hyperfractionated TBI, Thiotepa and Cyclophosphamide (TBI/Thio/cy) for Treatment of Patients Less Than or Equal to 18 Years With Lymphohematopoietic Disorders
- Determine the efficacy of hyperfractionated total body irradiation, thiotepa, and
cyclophosphamide followed by T-cell-depleted allogeneic bone marrow transplantation in
children with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous
leukemia, non-Hodgkin's lymphoma, or myelodysplastic syndromes.
- Correlate the progenitor cell dose and dose of clonable T cells with the incidence and
quality of engraftment, extent of chimerism, incidence and severity of acute and
chronic graft-versus-host disease, characteristics of hematopoietic and immunologic
reconstitution, and overall and disease-free survival at 2 years in patients treated
with this regimen.
OUTLINE: Patients undergo total body irradiation three times daily on days -9 to -7 and
twice on day -6. Patients receive thiotepa IV over 4 hours on days -5 and -4 and
cyclophosphamide IV over 30 minutes on days -3 and -2. Patients who cannot receive
cyclophosphamide, due to prior hemorrhagic cystitis or exposure to high-dose
cyclophosphamide or ifosfamide, receive fludarabine IV over 30 minutes on days -5 to -1.
Patients planning to receive family member HLA-mismatched or unrelated bone marrow
transplantation receive horse anti-thymocyte globulin IV once daily on days -5 and -4.
Patients undergo allogeneic T-cell-depleted bone marrow transplantation on day 0. Patients
receive filgrastim (G-CSF) IV every 12 hours beginning on day 7 and continuing until blood
Patients are followed every 2-4 weeks for the first 100 days post-transplantation, every 6
weeks for 6 months, every 3 months for 1 year, and then every 3-6 months until 2 years
PROJECTED ACCRUAL: A total of 50 patients (25 with HLA 6/6 antigen-matched related donors
and 25 with HLA 5/6 antigen-matched related donors or HLA 5/6 or 6/6 antigen-matched
unrelated donors) will be accrued for this study within 3 years.
Primary Purpose: Treatment
Minimal transplantation related mortality
Nancy A. Kernan, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|