drugset / Trial / NCT00864227
Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)
Phase 2
Completed
54 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
NaSingle-groupOpen-labelTreatment
Summary
A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.
Timeline
- Start
- 2008-12
- Primary completion
- 2011-04
- Completion
- 2013-11
Publications
- Results Brunstein CG, Fuchs EJ, Carter SL, Karanes C, Costa LJ, Wu J, Devine SM, Wingard JR, Aljitawi OS, Cutler CS, Jagasia MH, Ballen KK, Eapen M, O'Donnell PV; Blood and Marrow Transplant Clinical Trials Network. Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood. 2011 Jul 14;118(2):282-8. doi: 10.1182/blood-2011-03-344853. Epub 2011 Apr 28.
- Results Eapen M, O'Donnell P, Brunstein CG, Wu J, Barowski K, Mendizabal A, Fuchs EJ. Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Oct;20(10):1485-92. doi: 10.1016/j.bbmt.2014.05.015. Epub 2014 May 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hematopoietic Umbilical Cord Blood Stem Cell Transplantation | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | — | — |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | — |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Intravenous |