Clinical Trial on Acute Myeloid Leukemia - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Acute Myeloid Leukemia

Detailed Description

It is well known that tumor cells and leukemia cells express different surface structures (called antigens) that can serve as targets for cancer cell destruction by the immune system. Effective immune therapies are characterized by high specificity and low toxicity. One of the major obstacles impeding the use of these therapies as standard of care is the identification of good target antigens. In acute myeloid leukemia (AML) there is major patient to patient variation in leukemia antigens, so there is no universal AML cell target. Rather, each patient has a unique array of potential cell targets. Thanks to the rapid progress of new DNA/RNA sequencing technologies, the identification of these unique, patient-specific leukemia cell antigen-targets is now possible.

The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - La Jolla, California, United States, 92093
    - University of California San Diego
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with leukemia and their potential bone marrow donors.

Description

Inclusion Criteria:

Diagnosis of AML with plan to receive a bone marrow transplant

Exclusion Criteria:

NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genomics of patients with leukemia and their HLA matched bone marrow transplant donors. Time Frame: 5 years	To sequence the exome and transcriptome obtained from leukemia cells and the exome from their lymphocytes, and the lymphocytes from their HLA matched marrow transplant donors.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors Time Frame: 5 years	To select leukemia specific mutations (aka, variants), ie those that are different from both the patient's non-leukemic cells and their HLA matched marrow transplant donor's immune cells by comparing Leukemia cell, Patient normal cell, and Donor exome sequences.	5 years
Immunogenic mutant neoantigen peptide selection Time Frame: 5 years	To select peptides that represent the sequences obtained from Aim 2, according to their ability to bind to the identical patient/donor T cell major histocompatibility receptors.	5 years
Peptide immunogenicity confirmation and donor T cell stimulation Time Frame: 5 years	To test the peptides from Aim 3 for their in vitro immunogenicity for T lymphocytes obtained from the donor.	5 years
Data analysis and interpretation Time Frame: 5 years	To create and analyze a database summarizing the data obtained from Aims 1-4 for the purpose of IND submission and clinical trial design.	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PersImmune, Inc

Collaborators

University of California, San Diego

Investigators

Principal Investigator: Edward Ball, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria