NCT00737685

Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)

Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic Anemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Korean Society of Pediatric Hematology Oncology · Network
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing GVHD and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in UBMT/UPBSCT.

Detailed description

GVHD prophylaxis recommendation tacrolimus (0.03 mg/kg/day i.v. by continuous infusion from day -2 and taper with an oral form until 1 year after BMT/PBSCT) methotrexate (15 mg/m2 i.v. on days 1 and 10 mg/m2 i.v. on days 3, 6, 11)

Conditions

• Anemia, Aplastic

Interventions

Type	Name	Description
DRUG	cyclophosphamide, fludarabine , thymoglobulin	cyclophosphamide (50 mg/kg once daily i.v. on days -9, -8, -7 \& -6) fludarabine (30 mg/m2 once daily i.v. on days -5, -4, -3 \& -2) thymoglobulin (2.5 mg/kg once daily i.v. on days -3, -2 \& -1)

Timeline

• Start date: 2006-01-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2008-08-19
• Last updated: 2012-03-26

Locations

1 site across 1 country: South Korea