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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00943293
• Other study ID #: 12175A
• Status: Terminated
• Phase: Phase 1
• First received: July 20, 2009
• Last updated: March 14, 2014
• Start date: May 2003
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Lymphoma
• Myeloma
• Myeloproliferative Disorders
• Preleukemia

Intervention

Drug:
• Fludarabine
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.
• Melphalan
Melphalan 140 mg/m2 IV on day -2.
• Campath
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Locations

Country	Name	City	State
United States	The Uniiversity of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.		5 years	Yes