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

May 3, 2016 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

48

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

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

Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic stem cell transplant

Description

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 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Reduced Intensity Allogeneic Transplant
Subjects undergoing a reduced intensity allogeneic stem cell transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catalogue Data
Time Frame: 1 year
Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation.
1 year

Collaborators and Investigators

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

Sponsor

Duke University

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

August 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00041936

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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