A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
Twelve participants and 12 donors will be enrolled on this study. Donors will undergo seven
days of hematopoietic stem cell (HSC) mobilization followed by two apheresis collections.
Each apheresis collection will be processed by the CliniMACS system.
DONORS: A mobilization regimen of granulocyte colony stimulating factor (G-CSF) will be
used to obtain a peripheral blood stem cell (PBSC) product from the donor. Apheresis will
be performed for a minimum of two consecutive days, including one day for each cell product
STUDY PARTICIPANTS: Participants will undergo a two-stage haploidentical cell infusion
following myeloablative conditioning. The first cell infusion will be a CD3-depleted product
and the second infusion will be a CD45RA-depleted product.
- To determine the feasibility of haploidentical HSCT using two infusions engineered by
negative selection on the Miltenyi CliniMACS system- the first by selective depletion
of CD3+ cells, followed by a second depleted of CD45RA+ cells, in children with
relapsed or refractory solid tumors or lymphomas.
- To estimate hematopoietic cell recovery and engraftment rates for the patients.
- To estimate infection rates and complications.
- To estimate the one-year overall survival (OS) and event-free survival (EFS) for the
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of haploidentical HSCT
Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
30 days post transplantation
David R. Shook, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|