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

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Terminated
CT.gov ID
NCT02049424
Collaborator
(none)
9
Enrollment
1
Location
32.1
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective-prospective Observational Study for Data Collection of Patients Who Underwent an Haploidentical Transplantation After Non-myeloablative Conditioning Regimen
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    transplanted patients

    T-repleted haploidentical transplanted patients in Italy

    Outcome Measures

    Primary Outcome Measures

    1. toxicity evaluation [1 year]

      Chronic and acute GVHD, infectious complications, graft failure, TRM

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Clinico Humanitas Rozzano MI Italy 20089

    Sponsors and Collaborators

    • Istituto Clinico Humanitas

    Investigators

    • Principal Investigator: Luca Castagna, MD, Istituto Clinico Humanitas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Clinico Humanitas
    ClinicalTrials.gov Identifier:
    NCT02049424
    Other Study ID Numbers:
    • ONC/OSS-03/2011
    First Posted:
    Jan 30, 2014
    Last Update Posted:
    Jan 30, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Jan 30, 2014