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Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy


Phase 1
18 Years
65 Years
Not Enrolling
Both
Leukemia, Myelocytic, Acute

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Trial Information

Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy


Inclusion Criteria:



- AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20%
bone marrow blasts at the time of related donor marrow or stem cell transplantation
or at relapse post transplant.

- Willing to undergo a skin biopsy and either a leukodepletion apheresis or an
additional marrow aspiration.

- Stem cell or marrow donor willing to have apheresis for T-Cell collection.

- Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria:

- Medical, social or psychologic factors which would prevent the patient from receiving
or cooperating with the full course of therapy or understanding the informed consent
procedure.

- AML French-American-British (FAB) subtype M3.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Participant Toxicity Levels

Outcome Description:

Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.

Outcome Time Frame:

From stem cell transplant baseline to 30 plus days post transplant.

Safety Issue:

Yes

Principal Investigator

Elizabeth J. Shpall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID00-034

NCT ID:

NCT00048100

Start Date:

February 2001

Completion Date:

May 2005

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Dendritic cells
  • Lymphocytes
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030