Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS) — CyFluATG  

Myelodysplastic Syndrome Clinical Trial

Official title: Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome

Status Recruiting

Clinical Trial Summary

To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).

Clinical Trial Description

Conditioning therapy

• Cytoxan 50 mg/kg/d on d-3 to -2

• Fludarabine 30 mg/m2 on d-6 to -2

• Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)

• Methylpd 2 mg/kg/d on d-4 to -1

Mobilization and harvest

• G-CSF 10 mcg/kg/d s.c. on d-3 to 0

• Harvest of PBMCs on d 0 to +1

Donor G PBMC infusion

• Infuse G-PBMCs on d 0 to d+1.

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

Preemptive dose-escalating DLIs

• Begin at d+120 or at least 2 wks after IST discontinuation.

• Failure to achieve full donor chimerism No evidence of GVHD

• CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg) ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT01255319
• 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: N/A
• Start date: November 2010
• Completion date: November 2014