Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00597441

Purpose

The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation.

Condition	Intervention	Phase
Stem Cell Transplantation	Procedure: Thymic Transplantation for Recipients of UCB transplant	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation

Further study details as provided by Duke University:

Primary Outcome Measures:

Toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated UCBT. Thymic engraftment will be determined by biopsy of the thymus allograft and immunohistochemical evidence of thymopoiesis. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
To assess thymic function by measuring the number of naive T cells and the number of T cell receptor rearrangement excision circles (TRECS), and by assessing the diversity of the T cell receptor beta chain. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	9
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Thymic tissue from third party donor	Procedure: Thymic Transplantation for Recipients of UCB transplant Subjects with hematologic malignancies or bone marrow failure disorders will undergo umbilical cord blood transplantation and two months post transplant will have thymic tissue from a third party donor transplanted into the thigh muscle.

Detailed Description:

The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation. Thymic engraftment will be determined by biopsy of the thymus allograft and immunohistochemical evidence of thymopoiesis. In addition, we would like to assess thymic function by measuring the number of naive T cells and the number of T cell receptor rearrangement excision circles (TRECS), and by assessing the diversity of the T cell receptor beta chain. These data will be compared to age, stem-cell donor source and disease matched historical controls whose stem cell transplants were not followed by a thymus transplant. This will be done in descriptive fashion. Other immune parameters will be followed including T, B, and NK cell numbers, T cell responses to mitogens, antigens, and immunoglobulin production.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who received a dual cord blood transplant are eligible and must have achieved donor cord blood chimerism of > 75% in both T-cell and myeloid lineages
At the time of thymus transplantation, subjects cannot have active grade II-IV acute graft versus host disease.
At the time of thymus transplantation, the subject must have an absolute neutrophil count of > 500/ul and a platelet count of 50,000/ul (even if achieved via transfusion).
At the time of thymus transplantation, the subject must have < or equal to 50 circulating CD 34+ cells/ul (as measured within 3 weeks of transplant date).
At the time of thymus transplantation, subjects cannot be on greater than 2 mg/kg/day methylprednisolone or its equivalent of steroids.
At the time of thymus transplantation, PT and PTT must be less that 1.5 times the ULN or must be correctable to this level.
At the time of thymus transplantation, subjects cannot require oxygen or have pulmonary disease that would be thought to make general anesthesia a high risk.
Subjects must be between the ages of 18 and 60 years of age.

Exclusion Criteria:

Subjects cannot have bone marrow flow cytometry demonstrating residual leukemia
Subjects cannot have insufficient subcutaneous tissue and muscle mass to be able to accept and heal a thymus transplant, as assessed by a surgeon.
Prior to thymus transplantation, subjects cannot have evidence of active disease with HHV6, West Nile Virus, EBV, and CMV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597441

Contacts

Contact: Jennifer Loftis, RN, BSN, OCN	919-668-1939	lofti002@mc.duke.edu
Contact: Donna Adams, RN, BSN, OCN	919-668-4716	adams068@mc.duke.edu

Locations

United States, North Carolina
Duke University Health System	Recruiting
Durham, North Carolina, United States, 27710
Contact: Mitchell Horwitz, MD 919-668-1012 Horwi001@mc.duke.edu
Contact: Nelson Chao, MD 919-668-1011 chao0002@mc.duke.edu
Principal Investigator: Mitchell Horwitz, MD

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	Mitchell Horwitz, MD	Duke University Health System
Principal Investigator:	Mary L Markert, MD	Duke University Health System

More Information

No publications provided

Responsible Party:	Duke University Health Systems ( Mitchell Horwitz, MD )
Study ID Numbers:	00007995
Study First Received:	December 27, 2007
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00597441 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

unrelated
umbilical cord blood transplantation
thymus transplantation

ClinicalTrials.gov processed this record on September 11, 2009