Recruiting

ChromoSeq®

Sponsor:

Washington University School of Medicine

Code:

NCT07313592

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a prospective data collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young patients suspected of having ALL. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup as part of standard of care, and the patients will then be followed for clinical outcomes for up to 65 months.

Conditions

Acute Lymphoblastic Leukemia

Study ID

NCT07313592

Start date

Jun 3, 2026

Status verified date

Oct, 2026

Completion date

Jul 15, 2028

Anticipated

Primary completion date

Jul 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Eligibility Criteria

  • Children and young adult patients (< 30 years of age at time of study enrollment) treated at St. Louis Children's Hospital/Washington University School of Medicine.
  • Suspected diagnosis or suspected relapse of acute lymphoblastic leukemia (ALL), B- or T-cell.
  • Concurrent enrollment on a prospective therapeutic trial is allowed as this protocol makes no recommendations regarding treatment approach.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Child and Young Adult acute lymphoid leukemia (ALL) patients

Data collection will include patient and disease related characteristics such as demographic information, relevant medical history, ALL classification, diagnosis information, treatment, treatment response, recurrence data, and transplant data. Specific clinical data points collected will include ChromoSeq® testing results, minimal residual disease testing results at 8 days into treatment, end of induction (28 days into treatment) and end of consolidation if applicable (\~3 months into treatment), and time of any relapses from time of diagnosis.

Primary outcome measure

  • Rate of success of ChromoSeq® [ Time Frame: Time of specimen collection to completion of results (total estimated time is 15 days) ]

Central Contacts and Locations

Central contacts

Margaret Ferris, MD, PhD

314-454-6018youngm@wustl.edu

Locations

Washington University School of Medicine/St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Margaret Ferris, MD, PhD

314-454-6018youngm@wustl.edu

Principal Investigator:

Margaret Ferris, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Acute Lymphoblastic Leukemia
  • B-ALL
  • T-ALL
  • Next generation sequencing
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.