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

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00943293
First received: July 20, 2009
Last updated: July 8, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Preleukemia
Myeloproliferative Disorders
Lymphoma
Myeloma
Graft Versus Host Disease
 Drug: Fludarabine
Drug: Melphalan
Drug: Campath
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

Enrollment: 1
Study Start Date: May 2003
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943293

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

No publications provided

Responsible Party: Andrew Artz, MD, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00943293     History of Changes
Other Study ID Numbers: 12175A
Study First Received: July 20, 2009
Last Updated: July 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
GVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Lymphoma
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Hematologic Neoplasms
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Precancerous Conditions
Hematologic Diseases
Bone Marrow Diseases
 Neoplasms by Site
Melphalan
Fludarabine
Fludarabine monophosphate
Alemtuzumab
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013