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New treatment option for Acute Lymphoblastic Leukemia
Official 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
ClinicalTrials.gov ID: NCT04726241
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 22
You may be able to join if
- 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)
See the full eligibility 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Downey, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Hartford, Connecticut, United States
+ 134 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 148 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.