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New testing method may guide targeted treatments for young leukemia patients

NCT ID NCT02670525

Knowledge-focused Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study looks at whether a special type of testing, called leukemia profiling, can help find personalized treatment options for children and young adults up to age 30 with recurrent, refractory, or high-risk leukemias. Researchers analyze the genetic changes in each patient's cancer and have an expert panel recommend a targeted therapy or clinical trial. The goal is to see if this approach is feasible and can identify actionable genetic alterations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

338 people

The number who actually took part.

Started

Aug 2016

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Birth to ≤ 30 years at study entry * Diagnosis: Patients will be enrolled in one of the two cohorts based on diagnosis: Cohort 1: Relapsed/refractory leukemia * Acute lymphoblastic leukemia (ALL), first or greater relapse * Acute myeloid leukemia (AML), first or greater relapse * Leukemia refractory to induction chemotherapy * Other recurrent leukemia * Myelodysplastic syndrome (MDS), first or greater relapse, or refractory to initial therapy Cohort 2: New diagnosis * Acute myeloid leukemia (AML), new diagnosis * New diagnosis infant mixed-lineage leukemia (MLL)-rearranged ALL or low hypodiploid (\<40 chromosomes) ALL * Rare leukemia- e.g., juvenile myelomonocytic leukemia (JMML), leukemia of ambiguous lineage * Secondary leukemia * Myelodysplastic syndrome (MDS) not eligible for stem cell transplant Pathologic Criteria * Histologic confirmation of leukemia at the time of diagnosis or recurrence Specimen Samples * Sufficient leukemia specimen available for profiling from diagnosis or recurrence OR bone marrow aspirate/blood draw/pheresis/other fresh sample of patient leukemia cells planned for clinical care anticipated to allow collection of minimum specimen for testing. Exclusion Criteria: * Insufficient leukemia specimen available for profiling from diagnosis or recurrence; or bone marrow evaluation/blood draw/other leukemia cell sample NOT planned to be obtained for clinical care; or peripheral blast percentage \<20% AND clinical blood draw not planned.

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Conditions

The condition(s) this trial relates to.

acute leukemia of ambiguous lineage acute lymphoblastic leukemia acute myeloid leukemia B-lymphoblastic leukemia/lymphoma MLL rearranged B-lymphoblastic leukemia/lymphoma with hypodiploidy juvenile myelomonocytic leukemia myelodysplastic syndrome Recurrence therapy related acute myeloid leukemia and myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Matched targeted therapy Recurrent, refractory, or high risk leukemias

Contacts and locations

Locations

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19404, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's Hospital's and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • Washington University at St. Louis School of Medicine

    St Louis, Missouri, 63110, United States

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