Screening for pediatric leukemia in children with relapsed or difficult-to-treat cases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to screen children and young adults with relapsed or refractory acute leukemias by analyzing their clinical and biological characteristics. It involves collecting blood and bone marrow samples to determine eligibility for various pediatric leukemia sub-trials. The study also maintains a comprehensive registry and specimen bank to support ongoing research and treatment strategies. Patients will be monitored for several years after their participation to assess long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be less than 22 years of age at the time of study enrollment
* Patient must have one of the following at the time of study enrollment:

  * Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol

    * This includes isolated myeloid sarcoma
  * Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
  * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:

    * Second or greater B-ALL medullary relapse, excluding KMT2Ar
    * Any first or greater B-ALL medullary relapse involving KMT2Ar
    * Any first or greater T-ALL medullary relapse with or without KMT2Ar
  * Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
  * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
  * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)

    * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
  * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)

    * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• USA Health Strada Patient Care Center
  Mobile, Alabama, United States Recruiting
• Providence Alaska Medical Center
  Anchorage, Alaska, United States Recruiting
• Banner Children's at Desert
  Mesa, Arizona, United States Recruiting
• Phoenix Childrens Hospital
  Phoenix, Arizona, United States Recruiting
• Banner University Medical Center - Tucson
  Tucson, Arizona, United States Recruiting

+134 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Michele S Redell — Children's Oncology Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.