Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
NCT ID: NCT00048100
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2001-02-28
2005-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apheresis + Transplant
Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Apheresis
Apheresis for T-Cell collection
Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Interventions
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Apheresis
Apheresis for T-Cell collection
Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* AML French-American-British (FAB) subtype M3.
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elizabeth J. Shpall, MD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID00-034
Identifier Type: -
Identifier Source: org_study_id
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