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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943293
Recruitment Status : Terminated (Poor accrual; did not enter phase 2)
First Posted : July 22, 2009
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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 2003
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2012

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943293

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United States, Illinois
The Uniiversity of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Andrew Artz, M.D. University of Chicago

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Responsible Party: University of Chicago Identifier: NCT00943293    
Other Study ID Numbers: 12175A
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Graft vs Host Disease
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine phosphate
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological