NCT02667093

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

7.9 years

First QC Date

January 25, 2016

Last Update Submit

March 3, 2020

Conditions

Acute Myeloid Leukemia

Keywords

Acute LeukemiaAcute Myeloid LeukemiaAML

Outcome Measures

Primary Outcomes (1)

  • Genomics of patients with leukemia and their HLA matched bone marrow transplant donors.

    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 Outcomes (4)

  • Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors

    5 years

  • Immunogenic mutant neoantigen peptide selection

    5 years

  • Peptide immunogenicity confirmation and donor T cell stimulation

    5 years

  • Data analysis and interpretation

    5 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with leukemia and their potential bone marrow donors.

You may qualify if:

  • Diagnosis of AML with plan to receive a bone marrow transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

La Jolla, California, 92093, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (4)

  • Montagna D, Maccario R, Locatelli F, Rosti V, Yang Y, Farness P, Moretta A, Comoli P, Montini E, Vitiello A. Ex vivo priming for long-term maintenance of antileukemia human cytotoxic T cells suggests a general procedure for adoptive immunotherapy. Blood. 2001 Dec 1;98(12):3359-66. doi: 10.1182/blood.v98.12.3359.

    PMID: 11719375BACKGROUND

  • Kreiter S, Castle JC, Tureci O, Sahin U. Targeting the tumor mutanome for personalized vaccination therapy. Oncoimmunology. 2012 Aug 1;1(5):768-769. doi: 10.4161/onci.19727.

    PMID: 22934277BACKGROUND

  • Klebanoff CA, Gattinoni L, Restifo NP. Sorting through subsets: which T-cell populations mediate highly effective adoptive immunotherapy? J Immunother. 2012 Nov-Dec;35(9):651-60. doi: 10.1097/CJI.0b013e31827806e6.

    PMID: 23090074BACKGROUND

  • Brenner MK. Will T-cell therapy for cancer ever be a standard of care? Cancer Gene Ther. 2012 Dec;19(12):818-21. doi: 10.1038/cgt.2012.74. Epub 2012 Oct 12.

    PMID: 23059871BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be shipped to Persimmune for processing and storage with results shared with Dr. Ball and his lab at UCSD.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Edward Ball, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)