Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases
Summary
RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.
Timeline
- Start
- 2005-07-28
- Primary completion
- 2019-07-29
- Completion
- 2019-11-22
Publications
- Results Verneris MR, Brunstein CG, Barker J, MacMillan ML, DeFor T, McKenna DH, Burke MJ, Blazar BR, Miller JS, McGlave PB, Weisdorf DJ, Wagner JE. Relapse risk after umbilical cord blood transplantation: enhanced graft-versus-leukemia effect in recipients of 2 units. Blood. 2009 Nov 5;114(19):4293-9. doi: 10.1182/blood-2009-05-220525. Epub 2009 Aug 25.
- MacMillan ML, Weisdorf DJ, Brunstein CG, Cao Q, DeFor TE, Verneris MR, Blazar BR, Wagner JE. Acute graft-versus-host disease after unrelated donor umbilical cord blood transplantation: analysis of risk factors. Blood. 2009 Mar 12;113(11):2410-5. doi: 10.1182/blood-2008-07-163238. Epub 2008 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Cyclosporine | Peptide | 2.5 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 3 g | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |