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A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease


Phase 1
18 Years
N/A
Not Enrolling
Both
Allogeneic Stem Cell Transplantation

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Trial Information

A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease


The primary purpose of this clinical trial is to evaluate the safety of this treatment.


Inclusion Criteria:



- Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from
a 6/6 matched, sibling donor for the treatment of a malignancy

- Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from
a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.

- Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a
3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.

- Donor must be CMV sero-positive.

- Karnofsky performance status ≥ 70%.

- Subject and donor must be one of the following HLA types: HLA A*0201, HLA-A*0101,
HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*35, HLA-DR*1, or HLA-DR*4.

- Availability of the stem cell donor to provide multiple PBMC samples for T-cell
culture if needed. These samples could be obtained via a 90cc peripheral blood draw
or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for
undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis
if this is necessary.

- Ability to understand and provide signed informed consent that fulfills Institutional
Review Board guidelines.

- Ability to return to Duke University Medical Center for adequate follow-up as
required by this protocol.

- In order to receive their T cell infusions, subjects should be:

- At least 2 weeks from the time of their allogeneic stem cell transplant.

- Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1
week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion Criteria:

- Pregnant women and nursing mothers.

- Current or prior history of brain metastases.

- More than 12 months since their allogeneic stem cell re-infusion.

- HIV+, Hepatitis BsAg+, Hepatitis C Ab+

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of CMV pp65 specific CD8+ T cells produced.

Outcome Time Frame:

Pre-infusion.

Safety Issue:

No

Principal Investigator

H. Kim Lyerly, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

4138-07-10R5

NCT ID:

NCT00611637

Start Date:

August 2005

Completion Date:

June 2008

Related Keywords:

  • Allogeneic Stem Cell Transplantation
  • Immunotherapy

Name

Location

Duke University Medical CenterDurham, North Carolina  27710