Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048100

Enrollment

Registered

2002-10-25

Start date

2001-02-28

Completion date

2005-05-31

Last updated

2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelocytic, Acute

Keywords

Dendritic cells, Lymphocytes, AML

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.

Interventions

PROCEDUREApheresis

Apheresis for T-Cell collection

BIOLOGICALStem Cell Transplant

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Participant Toxicity Levels	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026