Study Stopped
Slow accrual.
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
1 other identifier
interventional
2
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2001
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 24, 2002
CompletedFirst Posted
Study publicly available on registry
October 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedOctober 31, 2018
October 1, 2018
4.2 years
October 24, 2002
October 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From stem cell transplant baseline to 30 plus days post transplant.
Study Arms (1)
Apheresis + Transplant
EXPERIMENTALSkin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Interventions
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M.D. Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth J. Shpall, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2002
First Posted
October 25, 2002
Study Start
February 1, 2001
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
October 31, 2018
Record last verified: 2018-10