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

Hematologic Malignancy Clinical Trial

Official title:

Retrospective-prospective Observational Study for Data Collection of Patients Who Underwent an Haploidentical Transplantation After Non-myeloablative Conditioning Regimen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02049424
• Other study ID #: ONC/OSS-03/2011
• Status: Terminated
• Phase: N/A
• First received: June 28, 2013
• Last updated: January 28, 2014
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hematologic Malignancy

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity evaluation	Chronic and acute GVHD, infectious complications, graft failure, TRM	1 year	Yes