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Taking people in Puerto RicoPhase 1/2

Testing bone marrow and blood in children with relapsed or hard-to-treat leukemia

Examines bone marrow and blood samples from young people with leukemia that returned.

Key facts

Who runs it
PedAL BCU, LLC
Where
Caguas and San Juan, Puerto RicoSee the 2 sitesAlso in 4 other countries, 182 sites
Trial code
Registry title
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
Status
Recruiting
Phase
Phase 1/2
People taking part
960 people, planned
Started
18 Apr 2022
Expected to end
31 Dec 2030
Type of study
Interventional
Treatments tested
  • Biospecimen Collection
Record updated
25 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children, teens and young adults under 22 whose leukemia or related blood disease has come back or did not respond to treatment. Blood and bone marrow are tested to find a fitting study.

Age
Under 22 years
Sex
All sexes can join
Disease stage
Known or suspected relapsed or hard-to-treat (refractory) acute myeloid leukemia (AML), myeloid leukemia of Down syndrome, mixed phenotype acute leukemia (MPAL), or juvenile myelomonocytic leukemia (JMML). Also relapsed B-ALL or T-ALL as defined in the protocol, and new or relapsed treatment-related AML, myelodysplastic syndrome (MDS) or treatment-related MDS.
Biomarker or test result
For B-ALL: a second or later relapse in the bone marrow, not counting KMT2Ar. Or any first or later B-ALL bone marrow relapse involving KMT2Ar. For T-ALL: any first or later bone marrow relapse, with or without KMT2Ar.

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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 in Puerto Rico

Also in 4 other countries, 182 sites

  • HIMA San Pablo Oncologic HospitalCaguas, Puerto RicoNo longer taking part
  • University Pediatric HospitalSan Juan, Puerto RicoContact: Maria E. Echevarria (principal investigator)Taking people

About the trial

What the trial wants to find out

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

The group in the trial

  • Screening (biospecimen collection)Treatment being tested

    Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).

    Treatment: Biospecimen Collection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Plain-language title
Testing bone marrow and blood in children with relapsed or hard-to-treat leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 August 2026