Bone Marrow and Blood Tests for Returning Childhood Leukemia
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
Recruiting
Phase 1Phase 2Interventional Study
Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia Post Cytotoxic TherapyJuvenile Myelomonocytic LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome Post Cytotoxic TherapyMyeloid Leukemia Associated With Down Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 22
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Screening
Participants needed
960 (estimated)
Sponsor
PedAL BCU, LLC · Other
Who this trial is looking for
This trial is looking for children under 22 who have leukemia that has come back or is hard to treat. Participants will undergo tests on their bone marrow and blood to help doctors better understand their condition and find new treatments.
Are You a Good Fit for This Trial?
You may be able to join if
I am less than 22 years old.
I have been diagnosed with relapsed or refractory acute myeloid leukemia.
I have been diagnosed with relapsed or refractory myeloid leukemia associated with Down syndrome.
I have been diagnosed with relapsed acute lymphoblastic leukemia.
I have been diagnosed with relapsed or refractory mixed phenotype acute leukemia.
I have been diagnosed with treatment-related acute myeloid leukemia.
I have been diagnosed with myelodysplastic syndrome.
I have been diagnosed with juvenile myelomonocytic leukemia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 d…
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.
Trial Locations
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Eligibility Criteria
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 in…
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
Contacts
No contact information available.
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