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

January 28, 2014 updated by: Istituto Clinico Humanitas

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

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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent a haploidentical transplantion after non-myeloablative conditioning regimen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
transplanted patients
T-repleted haploidentical transplanted patients in Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicity evaluation
Time Frame: 1 year
Chronic and acute GVHD, infectious complications, graft failure, TRM
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC/OSS-03/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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