NCT01252784

Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Detailed description

Conditioning therapy * Busulfan 3.2 mg/kg/d on d-7 to -6 * Fludarabine 30 mg/m2 on d-7 to -2 * ATG 1.5-3.0 mg/kg/d on d-3 to -1 * Methylpred 2 mg/kg/d on d-4 to -1 Mobilization and harvest * Donor * G-CSF 10 mcg/kg/d s.c. on d-3 to 0 * Harvest of PBMCs on d 0 to +1 Infuse G-PBMCs on d 0 to d+1. * Donor G-PBMC infusion GVHD prophylaxis * Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60. * Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7 Prophylactic dose-escalating DLIs * Begin at d+120 or at least 2 wks after IST discontinuation. * No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Conditions

• Myelodysplastic Syndrome

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2014-10-01
• First posted: 2010-12-03
• Last updated: 2010-12-03

Locations

1 site across 1 country: South Korea