Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

Phase 1

Terminated

• Conditions: Preleukemia; Myeloproliferative Disorders; Lymphoma; Myeloma; Graft Versus Host Disease
• Interventions: Drug: Fludarabine; Drug: Melphalan; Drug: Campath

• Registration Number: NCT00943293
• Lead Sponsor: University of Chicago

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	Campath	-
Vaccine	Melphalan	-
Vaccine	Fludarabine	-

Primary Outcome Measures

Name	Time	Method
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.	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.	5 years

Trial Locations

Locations (1)

The Uniiversity of Chicago; 🇺🇸 Chicago, Illinois, United States