Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors (GLOBAL)

NCT00354120 Phase 2/Phase 3 COMPLETED

The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.

Details

Lead sponsor	Gruppo Italiano Trapianto di Midollo Osseo
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	121
Start date	2005-03
Completion	2011-08

Conditions

• Acute Myeloblastic Leukemia
• Lymphoblastic Leukemia
• Myelodysplasia
• Chronic Myeloid Leukemia
• Myelofibrosis
• Lympho-proliferative Diseases

Interventions

• Alentuzumab
• Globulina antilinfocitaria

Primary outcomes

• Overall Survival — 3 years
• Event Free Survival and Disease Free Survival — 3 years
• Safety: — 3 years
• Major infective complications (CMV and EBV related PTLD) — 3 years
• Acute and chronic GvHD — 3 years

Countries

Italy