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

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ClinicalTrials.gov Identifier: NCT01904175
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Hodgkin's Disease Non Hodgkin's Lymphoma Myeloma Leukemia Myelodysplasia

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry Study of T Cell Depleted Allogeneic Non-Myeloablative Stem Cell Transplant Recipients
Study Start Date : August 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


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



Primary Outcome Measures :
  1. Catalogue Data [ Time Frame: 1 year ]
    Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic stem cell transplant
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904175


Locations
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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: David Rizzieri, MD Duke Health
Additional Information:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01904175    
Other Study ID Numbers: Pro00041936
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Keywords provided by Duke University:
Stem cell transplantation, non-myeloablative
Additional relevant MeSH terms:
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Hodgkin Disease
Preleukemia
Myelodysplastic Syndromes
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions