drugset / Trial / NCT01625351
A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
Phase 1
Completed
23 enrolled
St. Jude Children's Research Hospital
CURE Childhood Cancer, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Timeline
- Start
- 2012-08-20
- Primary completion
- 2020-02-10
- Completion
- 2020-02-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | — | — |
| Subject | Stem Cells | Cell therapy | — | — |
| Background | Alemtuzumab | Monoclonal antibody | — | — |
| Background | Busulfan | Small molecule | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Melphalan | Small molecule | — | — |