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Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

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ClinicalTrials.gov Identifier: NCT00048100
Recruitment Status : Terminated (Slow accrual.)
First Posted : October 25, 2002
Last Update Posted : August 23, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

  1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
  2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
  3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Procedure: Apheresis Biological: Stem Cell Transplant Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
Study Start Date : February 2001
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005


Arm Intervention/treatment
Experimental: Apheresis + Transplant
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Procedure: Apheresis
Apheresis for T-Cell collection
Biological: Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Other Names:
  • SCT
  • Stem Cell Transplantation



Primary Outcome Measures :
  1. Participant Toxicity Levels [ Time Frame: From stem cell transplant baseline to 30 plus days post transplant. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048100


Locations
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth J. Shpall, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00048100     History of Changes
Other Study ID Numbers: ID00-034
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Dendritic cells
Lymphocytes
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms