Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Phase 1TerminatedNCT00048100

M.D. Anderson Cancer Center2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myelocytic, Acute

Interventions

ApheresisPROCEDURE

Apheresis for T-Cell collection

Stem Cell TransplantBIOLOGICAL

Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

M.D. Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: From stem cell transplant baseline to 30 plus days post transplant.

Data from ClinicalTrials.gov

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