Trial Information
A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
Inclusion Criteria:
- Relapsed or refractory acute myelogenous or lymphoid leukemia.
- Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
- Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence.
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor
prognostic features.
Exclusion Criteria:
- Clinical progression.
- Contra-indications for vaccination.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Andrew Artz, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Chicago
Authority:
United States: Food and Drug Administration
Study ID:
12175A
NCT ID:
NCT00943293
Start Date:
May 2003
Completion Date:
January 2012
Related Keywords:
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma
- Myeloma
- Graft Versus Host Disease
- GVHD
- Graft vs Host Disease
- Lymphoma
- Preleukemia
- Myelodysplastic Syndromes
- Myeloproliferative Disorders
- Hematologic Neoplasms
Name | Location |
The Uniiversity of Chicago |
Chicago, Illinois 60637 |