drugset / Trial / NCT03600909
A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia
Phase 2
Terminated
3 enrolled
Memorial Sloan Kettering Cancer Center
Pediatric Brain Tumor Consortium · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this study is to see if the study therapy can decrease the chemotherapy-related side effects while maximizing the effectiveness of disease control. The physicians will also be studying the effect of removing T-cells from the donor"s stem cells before transplant. T-cells are a type of white blood cell that may help cause a serious side effect of transplant called Graft versus Host Disease (GVHD). The way it removes the T-cells from the donor stem cells is actually by selecting only the stem cells (called CD34 cells) by using a device called CliniMACS. This process is called CD34 selection. The CliniMACS® device is currently under the supervision of the FDA .
Timeline
- Start
- 2018-05-15
- Primary completion
- 2021-04-09
- Completion
- 2021-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.4 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 0.6 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 1 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 10 mg/kg | — |
| Background | Fludarabine | Small molecule | 35 mg/m2 | Intravenous |
| Background | G-CSF | Unknown | — | — |
| Background | Thymoglobulin | Protein / enzyme biologic | — | — |