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A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Preleukemia, Myeloproliferative Disorders, Lymphoma, Myeloma, Graft Versus Host Disease

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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 ChicagoChicago, Illinois  60637