Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation

NCT00597441 | Terminated Phase 1 DMC

• 1 other identifier: Pro00007995
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplantation

Keywords

unrelated; umbilical cord blood transplantation; thymus transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (2)

• 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.

  5 years

• 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.

  5 years

Study Arms (1)

I

EXPERIMENTAL

Thymic tissue from third party donor

Biological: Thymic Transplantation for Recipients of UCB transplant

Interventions

Thymic Transplantation for Recipients of UCB transplant BIOLOGICAL

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.

I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma Switzerland GmbH: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Study Officials

• Mitchell Horwitz, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

• Mary L Markert, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 18, 2008
• Study Start: November 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)