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NCT01904175 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Registry Study of T Cell Depleted Allogeneic Non-Myeloablative Stem Cell Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01904175
Other study ID # Pro00041936
Secondary ID
Status Completed
Phase N/A
First received December 5, 2012
Last updated May 3, 2016
Start date August 2013
Est. completion date April 2016

Study information
Verified date May 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Catalogue Data Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation. 1 year No
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