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
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| ClinicalTrials.gov Identifier: NCT04726241 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2021
Last Update Posted : June 22, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Recurrent B Acute Lymphoblastic Leukemia Recurrent Mixed Phenotype Acute Leukemia Recurrent T Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia Refractory Mixed Phenotype Acute Leukemia Therapy-Related Acute Myeloid Leukemia | Procedure: Biospecimen Collection |
PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.
OUTLINE:
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).
After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
| Study Type : | Observational |
| Estimated Enrollment : | 960 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | January 30, 2026 |
| Estimated Study Completion Date : | January 30, 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Observational (biospecimen collection)
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).
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Procedure: Biospecimen Collection
Undergo collection of blood and/or bone marrow samples
Other Names:
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- Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial [ Time Frame: Up to 5 years ]The proportion will be calculated as the percent of eligible patients who are identified to have an a priori specified genomic or immunophenotypic target and who enroll on at least one of the sub-trials. The corresponding confidence interval will be constructed.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | up to 22 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients must be less than 22 years of age at the time of study enrollment
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Patient must have one of the following:
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Patient has known or suspected relapsed/refractory (including primary refractory) AML
- This includes isolated myeloid sarcoma
- Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
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Patient has known or suspected relapsed ALL 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
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
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- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726241
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| Principal Investigator: | Todd M Cooper | Children's Oncology Group |
| Responsible Party: | Douglas Hawkins, MD, Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT04726241 |
| Other Study ID Numbers: |
APAL2020SC NCI-2021-00056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) APAL2020SC ( Other Identifier: Children's Oncology Group ) APAL2020SC ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2021 Key Record Dates |
| Last Update Posted: | June 22, 2022 |
| Last Verified: | June 2022 |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Acute Disease Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Attributes Pathologic Processes |