Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies
PRIMARY OBJECTIVES: I. To assess the feasibility in terms of toxicity and safety of HT in
combination with Fludarabine (fludarabine phosphate) and Melphalan as a preparative regimen
for allogeneic stem cell transplantation in patients with Hematological Malignancies: acute
lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndromes
SECONDARY OBJECTIVES: I. To evaluate within the confines of this pilot study, incidence of
neutrophil and platelet engraftment, survival on day +180, the overall survival, and disease
free survival in patients with Hematological Malignancies: ALL, AML, and MDS.
II. To evaluate incidence of primary and secondary engraftment failure, incidence of
relapse, incidence of acute and chronic transplant related complications, including
veno-occlusive disease of the liver (VOD), organ toxicity, secondary malignancies, including
treatment-related myelodysplastic syndrome, and acute and chronic graft-versus-host disease
(GVHD), as well as post-transplant chimerism.
OUTLINE: PREPARATIVE REGIMEN*: Patients receive fludarabine phosphate intravenously (IV) on
days -7 to -3 and melphalan IV on day -2. Patients also undergo HT twice daily on days -7 to
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day
0. NOTE: *Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus
for GVHD prophylaxis.
After completion of study treatment, patients are followed up periodically for 2 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of helical tomotherapy (HT) in combination with fludarabine and melphalan followed by allogeneic stem cell transplantation
100 days post treatment
Joseph Rosenthal, MD
City of Hope Medical Center
United States: Federal Government
|City of Hope Medical Center||Duarte, California 91010|