drugset / Trial / NCT00603954
Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings
Phase 2
Completed
107 enrolled
University of Liege
KU Leuven · collabMaastricht University Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy TLI with ATG.
Timeline
- Start
- 2008-01
- Primary completion
- 2016-07
- Completion
- 2016-07
Publications
- Hannon M, Beguin Y, Ehx G, Servais S, Seidel L, Graux C, Maertens J, Kerre T, Daulne C, de Bock M, Fillet M, Ory A, Willems E, Gothot A, Humblet-Baron S, Baron F. Immune Recovery after Allogeneic Hematopoietic Stem Cell Transplantation Following Flu-TBI versus TLI-ATG Conditioning. Clin Cancer Res. 2015 Jul 15;21(14):3131-9. doi: 10.1158/1078-0432.CCR-14-3374. Epub 2015 Mar 16.
- Baron F, Zachee P, Maertens J, Kerre T, Ory A, Seidel L, Graux C, Lewalle P, Van Gelder M, Theunissen K, Willems E, Emonds MP, De Becker A, Beguin Y. Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society. J Hematol Oncol. 2015 Feb 6;8:4. doi: 10.1186/s13045-014-0098-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | — |