Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
- To assess non-relapse or progression-related mortality at 1 year in patients over 55
with hematological malignancies undergoing allogeneic hematopoietic stem cell
transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated
with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte
- To assess the incidence of graft-versus-host disease in these patients.
- To assess the incidence of relapse in these patients.
- To assess cellular recovery in these patients.
- To assess myeloid and lymphocyte chimerism in these patients.
- To study the usual clinical and biological aspects of the transplantation in these
- To study the impact of the Charlson score and the suitability for allogeneic
transplantation score on mortality and 1-year survival.
- To assess the quality of life (QLQ-C30) of these patients.
- To study the economic cost of transplantation from conditioning to 1 year
- To study the mobilization and collection of progenitor stem cells in the donors.
- To study the psychological impact of donating stem cells on the donors.
OUTLINE: This is a multicenter study.
- Conditioning: Patients receive fludarabine phosphate IV over 30 minutes on days -5
through -1, busulphan IV over 2 hours every 6 hours on days -4 and -3, and
anti-lymphocyte globulin IV over 4 hours on days -2 and -1.
- Transplantation: Patients undergo allogeneic hematopoietic stem call transplantation on
Patients complete a quality of life survey (QLQ-C30). After completion of study treatment,
patients are followed every month for 6 months and then every 3 months for 6 months.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Allogeneic hematopoietic stem cell transplant-related mortality
Didier Blaise, MD
United States: Federal Government