Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
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|ClinicalTrials.gov Identifier: NCT00048100|
Recruitment Status : Terminated (Slow accrual.)
First Posted : October 25, 2002
Last Update Posted : August 23, 2012
- 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 or disease||Intervention/treatment||Phase|
|Leukemia, Myelocytic, Acute||Procedure: Apheresis Biological: Stem Cell Transplant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
Experimental: Apheresis + Transplant
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Apheresis for T-Cell collectionBiological: Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
- Participant Toxicity Levels [ Time Frame: From stem cell transplant baseline to 30 plus days post transplant. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048100
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Elizabeth J. Shpall, MD||UT MD Anderson Cancer Center|