Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

This study has been terminated.

First Received: October 24, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00048100

Purpose

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 AML or CML-BC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.

Condition	Intervention	Phase
Leukemia, Myelocytic, Acute	Procedure: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	30
Study Start Date:	February 2001

Eligibility

Criteria

Inclusion:

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:

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 FAB subtype M3.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048100

Locations

Sponsors and Collaborators

M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID00-034
Study First Received:	October 24, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00048100 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Dendritic cells
Lymphocytes
AML

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on November 05, 2009