drugset / Trial / NCT03885947
VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies
NaSequentialOpen-labelTreatment
Summary
In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).
Timeline
- Start
- 2019-02-21
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cord blood stem cells | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/m2 | — |
| Background | Fludarabine | Small molecule | 150 mg/m2 | — |
| Background | Thiotepa | Other / unclassified | 10 mg/m2 | — |
| Background | Valproic Acid | Small molecule | — | — |