Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00048100

Purpose

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.

Condition	Intervention	Phase
Leukemia, Myelocytic, Acute	Procedure: Apheresis Procedure: Stem Cell Transplant	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Cancer Leukemia

U.S. FDA Resources

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

Primary Outcome Measures:

Participant Toxicity Levels [ Time Frame: From stem cell transplant baseline to 30 plus days post transplant. ] [ Designated as safety issue: Yes ]
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.

Enrollment:	2
Study Start Date:	February 2001
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apheresis + Transplant Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.	Procedure: Apheresis Apheresis for T-Cell collection Procedure: Stem Cell Transplant Stem cell or marrow infusion. Other Names: SCT Stem Cell Transplantation

Eligibility

Criteria

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.

Contacts and Locations

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

Locations

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Elizabeth J. Shpall, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Elizabeth J. Shpall, MD / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00048100 History of Changes
Other Study ID Numbers:	ID00-034
Study First Received:	October 24, 2002
Last Updated:	March 23, 2011
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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012