drugset / Trial / NCT03159702
Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm, phase II study to determine the safety of propylene glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning for haploidentical transplantation. In addition, the study evaluates the one-year progression-free survival of patients undergoing this treatment.
Timeline
- Start
- 2017-12-08
- Primary completion
- 2024-11-12
- Completion
- 2025-12-08
Publications
- Background Van Besien K, Devine S, Wickrema A, Jessop E, Amin K, Yassine M, Maynard V, Stock W, Peace D, Ravandi F, Chen YH, Hoffman R, Sossman J. Regimen-related toxicity after fludarabine-melphalan conditioning: a prospective study of 31 patients with hematologic malignancies. Bone Marrow Transplant. 2003 Sep;32(5):471-6. doi: 10.1038/sj.bmt.1704166.
- Background Brammer JE, Khouri I, Gaballa S, Anderlini P, Tomuleasa C, Ahmed S, Ledesma C, Hosing C, Champlin RE, Ciurea SO. Outcomes of Haploidentical Stem Cell Transplantation for Lymphoma with Melphalan-Based Conditioning. Biol Blood Marrow Transplant. 2016 Mar;22(3):493-8. doi: 10.1016/j.bbmt.2015.10.015. Epub 2015 Oct 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |