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Registry Study of T Cell Depleted Allo Non-Myeloablative Stem Cell Transplant

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01904175
Collaborator
(none)
48
Enrollment
1
Location
32
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The investigators and others have shown that less toxic preparative regimens (reduced intensity or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions, significantly broadening the population of patients who may be offered this therapy to those who are older and more infirmed. The field is now focusing on the period post transplant for approaches to immune recovery leading to improved outcomes.

The primary objective of this registry is to catalogue data from patients who undergo standard of care reduced intensity allogeneic transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subjects will have toxicity monitored and reported per the Center for International Blood and Marrow Transplant Research (CIBMTR) program standard and as required by law for bone marrow transplant (BMT) reporting in the USA. Data will be collected from physical exam, laboratory studies, radiographs that are performed for clinical purposes. The tests and procedures are not in addition or in excess of our standards for allogeneic transplant outside of this registry. Data about donors will also be collected.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    48 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Registry Study of T Cell Depleted Allogeneic Non-Myeloablative Stem Cell Transplant Recipients
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Apr 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Reduced Intensity Allogeneic Transplant

    Subjects undergoing a reduced intensity allogeneic stem cell transplant

    Outcome Measures

    Primary Outcome Measures

    1. Catalogue Data [1 year]

      Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Recipient Inclusion Criteria:
    • Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic transplant
    Exclusion Criteria:

    • Subjects < 18 years of age

    • Subjects not undergoing nonmyeloablative or ablative allogeneic transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Health System Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: David Rizzieri, MD, Duke Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01904175
    Other Study ID Numbers:
    • Pro00041936
    First Posted:
    Jul 22, 2013
    Last Update Posted:
    May 5, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Duke University
    Stem cell transplantation, non-myeloablative
    Additional relevant MeSH terms:
    Hodgkin Disease
    Preleukemia
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of May 5, 2016