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

This study has been terminated.
(Poor accrual; did not enter phase 2)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00943293
First received: July 20, 2009
Last updated: March 14, 2014
Last verified: March 2014

July 20, 2009
March 14, 2014
May 2003
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00943293 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma
  • Myeloma
  • Graft Versus Host Disease
  • 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.
Experimental: Vaccine
Interventions:
  • Drug: Fludarabine
  • Drug: Melphalan
  • Drug: Campath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
January 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943293
12175A
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Andrew Artz, M.D. University of Chicago
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP