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

Primary Purpose

Preleukemia, Myeloproliferative Disorders, Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Melphalan
Campath
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preleukemia focused on measuring GVHD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • Clinical progression.
  • Contra-indications for vaccination.

Sites / Locations

  • The Uniiversity of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2009
Last Updated
March 14, 2014
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00943293
Brief Title
Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual; did not enter phase 2
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preleukemia, Myeloproliferative Disorders, Lymphoma, Myeloma, Graft Versus Host Disease
Keywords
GVHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Melphalan 140 mg/m2 IV on day -2.
Intervention Type
Drug
Intervention Name(s)
Campath
Intervention Description
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Artz, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Uniiversity of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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