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

University of Chicago1 site in 1 country1 target enrollmentMay 2003

ConditionsPreleukemia Myeloproliferative Disorders Lymphoma Myeloma Graft Versus Host Disease

InterventionsFludarabine Melphalan Campath

DrugsFludarabine Melphalan Campath

Overview

Phase: Phase 1
Intervention: Fludarabine
Conditions: Preleukemia
Sponsor: University of Chicago
Enrollment: 1
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

January 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Vaccine

Intervention: Fludarabine

Vaccine

Intervention: Melphalan

Vaccine

Intervention: Campath

Outcomes

Primary Outcomes

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