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Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia

Leukemia Clinical Trial

Official title:
Treatment Protocol: Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia Using Conditioning Regimen Without Radiation

Clinical Trial Summary

Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality for patients with leukemia and myelodysplasia. UCB is now considered "Standard Of Care" in cases where a suitable living bone marrow donor is not available. The survival of UCB is similar to Matched Unrelated Marrow Transplant. This study is considered "Research" since UCB is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.

Clinical Trial Description

The preparative regimen will consist of:

- Fludarabine: 25 mg/m2/day IV x 5 doses on Days -13, to -9

- Busulfan 1mg/kg IV every 6 hrs x 16 doses on Days -8 to -5

- Melphalan 45 mg/m2/day IV x 3 doses on days -4 to -2

- ATGAM 30mg/kg/day x 3 doses on Days -3 to -1

- Day 0 will be the day of the UCB Transplant

- The graft-versus-host-disease (GVHD) prophylaxis will be Cyclosporin A to maintain level 200-400 beginning on Day -3, through 200-400. Solumedrol at 1mg/kg/day on Day 1 until D+4, then solumedrol 2mg/kg/day until Day +19 or till absolute neutrophil count (ANC) reaches 500/mm2, then taper by 0.2 mg/kg/week. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02007863
Study type Interventional
Source University of Miami
Contact
Status Completed
Phase N/A
Start date August 2008
Completion date June 2014
View Details
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