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

NCT00943293 | Terminated Phase 1 DMC

• 1 other identifier: 12175A
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Preleukemia; Myeloproliferative Disorders; Lymphoma; Myeloma; Graft Versus Host Disease

Keywords

GVHD

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

Vaccine

EXPERIMENTAL

Drug: Fludarabine; Drug: Melphalan; Drug: Campath

Interventions

Fludarabine DRUG

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.

Vaccine

Melphalan DRUG

Melphalan 140 mg/m2 IV on day -2.

Vaccine

Campath DRUG

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinical progression.
• Contra-indications for vaccination.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The Uniiversity of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Preleukemia; Myeloproliferative Disorders; Lymphoma; Neoplasms, Plasma Cell; Graft vs Host Disease

Interventions

fludarabine; Melphalan; Alemtuzumab

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Andrew Artz, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: May 1, 2003
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

US (1)