Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies - Full Text View

Sponsor:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00943293

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 I Phase II

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:

MedlinePlus related topics: Cancer Lymphoma Myelodysplastic Syndromes

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab Melphalan Sarcolysin Melphalan hydrochloride

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 ]

Estimated Enrollment:	25
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Melphalan 140 mg/m2 IV on day -2.

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:

Koen van Besien, M.D.

University of Chicago

More Information

No publications provided

Responsible Party:	Dr. Koen van Besien, The University of Chicago
ClinicalTrials.gov Identifier:	NCT00943293 History of Changes
Other Study ID Numbers:	12175A
Study First Received:	July 20, 2009
Last Updated:	June 14, 2011
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 February 09, 2012