Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes - Tabular View

Tracking Information
First Received Date ^ICMJE	October 24, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	February 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00048100 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Official Title ^ICMJE	Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
Brief Summary	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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Leukemia, Myelocytic, Acute
Intervention ^ICMJE	Procedure: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00048100
Responsible Party
Study ID Numbers ^ICMJE	ID00-034
Study Sponsor ^ICMJE	M.D. Anderson Cancer Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	M.D. Anderson Cancer Center
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP