Back to resultsAnti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Primary Purpose
Leukemia, Myelocytic, Acute
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apheresis
Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myelocytic, Acute focused on measuring Dendritic cells, Lymphocytes, AML
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.
Sites / Locations
- M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apheresis + Transplant
Arm Description
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Outcomes
Primary Outcome Measures
Participant Toxicity Levels
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00048100
First Posted
October 24, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00048100
Brief Title
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Official Title
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual.
Study Start Date
February 2001 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelocytic, Acute
Keywords
Dendritic cells, Lymphocytes, AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apheresis + Transplant
Arm Type
Experimental
Arm Description
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Intervention Type
Procedure
Intervention Name(s)
Apheresis
Intervention Description
Apheresis for T-Cell collection
Intervention Type
Biological
Intervention Name(s)
Stem Cell Transplant
Other Intervention Name(s)
SCT, Stem Cell Transplantation
Intervention Description
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Primary Outcome Measure Information:
Title
Participant Toxicity Levels
Description
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.
Time Frame
From stem cell transplant baseline to 30 plus days post transplant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J. Shpall, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website
Learn more about this trial
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
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