drugset / Trial / NCT00582816

Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

NCT00582816

NaSingle-groupOpen-labelTreatment

Summary

This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.

Timeline

Start
2008-08
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclosporine Peptide
Background Equine ATG Unknown
Background Fludarabine Small molecule
Background Melphalan Small molecule
Background Methylprednisolone Other / unclassified
Background Rituximab Monoclonal antibody
Background Thiotepa Other / unclassified

Indications