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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Preleukemia, Myeloproliferative Disorders, Lymphoma, Myeloma, Graft Versus Host Disease

Intervention / Treatment
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* Drug: Fludarabine
* Drug: Melphalan
* Drug: Campath


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GVHD