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

NCT ID: NCT02049424

Last Updated: 2014-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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)

Conditions

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Hematologic Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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transplanted patients

T-repleted haploidentical transplanted patients in Italy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Castagna, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, MI, Italy

Site Status

Countries

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Italy

References

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Roberto A, Castagna L, Zanon V, Bramanti S, Crocchiolo R, McLaren JE, Gandolfi S, Tentorio P, Sarina B, Timofeeva I, Santoro A, Carlo-Stella C, Bruno B, Carniti C, Corradini P, Gostick E, Ladell K, Price DA, Roederer M, Mavilio D, Lugli E. Role of naive-derived T memory stem cells in T-cell reconstitution following allogeneic transplantation. Blood. 2015 Apr 30;125(18):2855-64. doi: 10.1182/blood-2014-11-608406. Epub 2015 Mar 5.

Reference Type DERIVED
PMID: 25742699 (View on PubMed)

Roberto A, Castagna L, Gandolfi S, Zanon V, Bramanti S, Sarina B, Crocchiolo R, Todisco E, Carlo-Stella C, Tentorio P, Timofeeva I, Santoro A, Della Bella S, Roederer M, Mavilio D, Lugli E. B-cell reconstitution recapitulates B-cell lymphopoiesis following haploidentical BM transplantation and post-transplant CY. Bone Marrow Transplant. 2015 Feb;50(2):317-9. doi: 10.1038/bmt.2014.266. Epub 2014 Nov 24. No abstract available.

Reference Type DERIVED
PMID: 25419693 (View on PubMed)

Other Identifiers

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ONC/OSS-03/2011

Identifier Type: -

Identifier Source: org_study_id

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