Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Study Overview
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Brief Summary
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Objectives: 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. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion. 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.

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

Conditions
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Leukemia, Myelocytic, Acute

Intervention / Treatment
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* Procedure: Apheresis
* Biological: Stem Cell Transplant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apheresis + Transplant<br>Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation. | Procedure: Apheresis<br>* Apheresis for T-Cell collection<br>Biological: Stem Cell Transplant<br>* Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).<br>* Other names: Stem Cell Transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Toxicity Levels | 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. | From stem cell transplant baseline to 30 plus days post transplant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dendritic cells, Lymphocytes, AML