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

Completed

• Conditions: Myeloma; Leukemia; Myelodysplasia; Hodgkin's Disease; Non Hodgkin's Lymphoma

• Registration Number: NCT01904175
• Lead Sponsor: Duke University

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.

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 Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Study Start: 2013-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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Exclusion Criteria

• Subjects < 18 years of age
• Subjects not undergoing nonmyeloablative or ablative allogeneic transplant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Catalogue Data	1 year	Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States