Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00943293|
Recruitment Status : Terminated (Poor accrual; did not enter phase 2)
First Posted : July 22, 2009
Last Update Posted : March 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Preleukemia Myeloproliferative Disorders Lymphoma Myeloma Graft Versus Host Disease||Drug: Fludarabine Drug: Melphalan Drug: Campath||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||January 2012|
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.
Melphalan 140 mg/m2 IV on day -2.
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
- To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity. [ Time Frame: 5 years ]
- To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation. [ Time Frame: 5 years ]
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): NCT00943293
|United States, Illinois|
|The Uniiversity of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Andrew Artz, M.D.||University of Chicago|