Observational Study in Patients Who Underwent an Haploidentical Transplantation With T-repleted Bone Marrow

Terminated

• Conditions: Hematologic Malignancy

• Registration Number: NCT02049424
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow after post-transplantation cyclophosphamide

Detailed Description

Patients who underwent transplantation with T-repleted bone marrow haploidentical transplantation will be analyzed considering toxicity incidence (GVHD, infective complications, graft-failure incidence and TRM)and efficacy variables (Overall Survival, Progression Free Survival and Relapse incidence)

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-06-28
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Study First Posted: 2014-01-30
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• patients affected by hematologic neoplasia who underwent a haploidentical transplantation (2-3 mismatches) from a familiar donor, with non-ex vivo manipulated bone marrow and post-transplantation cyclophosphamide

Exclusion Criteria

• ex vivo manipulated bone marrow transplantation
• use of antilymphocyte serum during conditioning

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
toxicity evaluation	1 year	Chronic and acute GVHD, infectious complications, graft failure, TRM

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy