drugset / Trial / NCT02988466
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
Timeline
- Start
- 2017-01-24
- Primary completion
- 2023-05-02
- Completion
- 2025-03-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludarabine | Small molecule | — | — |
| Subject | HLA-haploidentical related hematopoietic cells transplant | Cell therapy | — | — |
| Subject | Melphalan | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |