drugset / Trial / NCT00412360
Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
Phase 3
Completed
224 enrolled
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Marrow Donor Program · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
This study is a Phase III, randomized, open-label, multi-center, prospective study of single umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric patients with hematologic malignancies.
Timeline
- Start
- 2006-12
- Primary completion
- 2014-03
- Completion
- 2014-10
Publications
- Background Shulman HM, Sullivan KM, Weiden PL, McDonald GB, Striker GE, Sale GE, Hackman R, Tsoi MS, Storb R, Thomas ED. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients. Am J Med. 1980 Aug;69(2):204-17. doi: 10.1016/0002-9343(80)90380-0.
- Results Wagner JE Jr, Eapen M, Carter S, Wang Y, Schultz KR, Wall DA, Bunin N, Delaney C, Haut P, Margolis D, Peres E, Verneris MR, Walters M, Horowitz MM, Kurtzberg J; Blood and Marrow Transplant Clinical Trials Network. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. 2014 Oct 30;371(18):1685-94. doi: 10.1056/NEJMoa1405584.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | — | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Intravenous |