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


Phase 1
18 Years
60 Years
Not Enrolling
Both
Stem Cell Transplantation

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Mitchell Horwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Food and Drug Administration

Study ID:

Pro00007995

NCT ID:

NCT00597441

Start Date:

November 2005

Completion Date:

May 2010

Related Keywords:

  • Stem Cell Transplantation
  • unrelated
  • umbilical cord blood transplantation
  • thymus transplantation

Name

Location

Duke University Health SystemDurham, North Carolina  27705