Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00048100
First received: October 24, 2002
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Leukemia, Myelocytic, Acute
Procedure: Apheresis
Biological: Stem Cell Transplant
Phase 1

Study Type: Interventional
Study Design: 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:


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
Biological: Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Other Names:
  • SCT
  • Stem Cell Transplantation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Elizabeth J. Shpall, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00048100     History of Changes
Other Study ID Numbers: ID00-034
Study First Received: October 24, 2002
Last Updated: August 22, 2012
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 April 17, 2014