Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Stopped early · Phase 1

Conditions studied: Leukemia, Myelocytic, Acute

In brief

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.

Key facts

Study ID

NCT00048100

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2001-02-01

Expected to finish

2005-05-01

Last updated by the study team

2018-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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