Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation — RICandDLI  

Myelodysplastic Syndrome Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT01252784
• Study type: Observational
• Source: Cooperative Study Group A for Hematology
• Contact: Je-Hwan Lee, Doctor
• Phone: 82-2-3010-3218
• Email: jhlee3@amc.seoul.kr
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2010
• Completion date: October 2014