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Acute Lymphoblastic Leukemia Therapies Informed by Genomic Analyses

NCT02580981 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-01-11

No results posted yet for this study

Summary

Previous work performed by University of New Mexico Comprehensive Cancer Center (UNMCCC) investigators has revealed previously unknown genomic mutations in children, adolescents, and young adults with high-risk B and T cell precursor acute lymphoblastic leukemia (ALL). Using genomic and next generation DNA sequencing technologies, these investigators revealed that 14% of children with high-risk ALL have "Philadelphia chromosome-like" ("Ph-like") ALL. Patients with this form of ALL were found to have a significantly increased risk of treatment failure and death.

Further work revealed that there are more than 40 distinct gene rearrangements and fusions that can result in Ph-like ALL. Cell lines and human leukemic cells expressing some of these different gene fusions were sensitive to currently available drugs. This suggests that Ph-like ALL patients with these specific distinct gene fusions should be targeted in future clinical trials to be treated with appropriate therapy. Further work is also needed to identify other potentially targetable genetic alterations in ALL patients.

Therefore, the goal of this study is to perform genomic screening of all newly diagnosed ALL patients seen at UNM and to use this information to enroll patients onto available National Clinical Trial Network (NCTN) clinical trials. If an appropriate NCTN trial is not available, best clinical management will be pursued.

Conditions

  • Leukemia, Acute Lymphoblastic

Interventions

OTHER

Acute Lymphobastic Leukemia (ALL) Treatment Options

Depending on the genomic testing results, patients with targetable genomic lesions will be enrolled onto available national clinical trials that are sponsored by the NCI National Clinical Trials Network (NCTN) (COG and other adult NCI Cooperative Groups). If no suitable NCTN trial exists, appropriate therapeutic regimens (including currently accepted standards-of-care), alterations in therapy, or treatment with targeted agents to specific genomic lesions will be considered.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Jodi Mayfield, MD · University of New Mexico, Department of Pediatrics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-28
Primary Completion
2022-03-19
Completion
2022-10-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02580981 on ClinicalTrials.gov