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

Sponsor

University of Chicago (Other)

Overall Status

Terminated

CT.gov ID

NCT00943293

Collaborator

(none)

Enrollment

Location

Arm

104

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Preleukemia Myeloproliferative Disorders Lymphoma Myeloma Graft Versus Host Disease	Drug: Fludarabine Drug: Melphalan Drug: Campath	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 1, 2003

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaccine	Drug: Fludarabine Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3. Drug: Melphalan Melphalan 140 mg/m2 IV on day -2. Drug: Campath Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Arm

Intervention/Treatment

Experimental: Vaccine

Drug: Fludarabine

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.

Drug: Melphalan

Melphalan 140 mg/m2 IV on day -2.

Drug: Campath

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.