NCT01015742

Unrelated Double Umbilical Cord Blood Units Transplantation

Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphoblastic, Acute
• Leukemia, Myeloid, Chronic

Interventions

Type	Name	Description
DRUG	Stem cell Transplantation	Busulfan: 3.2 mg/kg IV daily on days -7 to -4 Cyclophosphamide : 60 mg/m² daily on days -3 to -2 Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2 Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90 Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2009-11-18
• Last updated: 2012-06-04

Locations

1 site across 1 country: Iran