Acute Lymphoblastic Leukemia Therapies Informed by Genomic Analyses

Recruiting in Palo Alto (17 mi)

Overseen by Jodi Mayfield, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: New Mexico Cancer Research Alliance

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jodi Mayfield, MD

Principal Investigator

University of New Mexico, Department of Pediatrics

Eligibility Criteria

Inclusion Criteria

New diagnosis of Acute Lymphoblastic Leukemia

Any age

Ability to understand and the willingness to sign a written informed consent document.

Treatment Details

Interventions

• Acute Lymphoblastic Leukemia Therapies Informed by Genomic Analyses (Genomic Therapy)

Participant Groups

Group I: Genomic Testing Experimental Treatment 1 Intervention

Newly diagnosed ALL patients will undergo genomic studies listed in Primary Objective 1. Analyses will be performed on a bone marrow (BM) aspirate at initial diagnosis (patients with an absolute blast count of at least 1,000/μL, may submit 2 mL of peripheral blood at diagnosis for each 1 mL of required BM. In patients in whom the aspirate cannot be obtained, a core biopsy will be used). In addition, flow cytometric analysis and deep sequencing will be used to characterize and monitor the molecular heterogeneity and clonal evolution of disease during front-line therapy. BM, blood, and buccal specimens will be collected on day 29 of induction treatment and possibly at a later time point if relapse occurs.

Who Is Running the Clinical Trial?

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

Dr. Fontaine

New Mexico Cancer Research Alliance

Chief Medical Officer since 2006

Physician Executive MBA from University of Tennessee

Dr. Barbara McAneny

New Mexico Cancer Research Alliance

Chief Executive Officer since 1987

MD from University of Iowa College of Medicine

New Mexico Cancer Care Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

Dr. Barbara McAneny

New Mexico Cancer Care Alliance

Chief Executive Officer since 1987

MD from University of Iowa

Dr. Fontaine

New Mexico Cancer Care Alliance

Chief Medical Officer since 2006

Physician Executive MBA from University of Tennessee