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โ† Trials
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Leukemia Adapted Protocol

Recruitingn/aAges any - 18 YearsAllBaylor College of Medicine
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In plain words

What the trial is, and whether it could suit you

In resource-constrained settings such as Malawi, survival rates for pediatric acute myeloid leukemia (AML) are dismally low compared to high-resource environments. This disparity highlights the urgent need for feasible treatment protocols tailored to the realities of these regions where most children with cancer are treated. In 2023, after reviewing favorable clinical trials results in other resource-limited settings, the Kamuzu Central Hospital (KCH) pediatric cancer unit adopted an evidence-based intensity-adapted clinical practice guideline (CPG) developed by the International Society of Paediatric Oncology (SIOP) as its standard of care for the treatment of pediatric AML, aiming to balance curative intent with manageable toxicity. The current study is a prospective evaluation of outcomes of standard of care in Malawi using the SIOP CPG in a real-world setting. The LEAP study aims to

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age Patients must be \<18 years of age at time of study enrollment. 2. Diagnosis Patients must be diagnosed with de novo AML according to 2022 WHO 5th Edition classification with or without extramedullary disease. Patients must have one of the following: * Bone marrow myeloblasts โ‰ฅ20%. In cases of dry taps due to fibrosis, myeloblast percentage can be estimated from a bone marrow biopsy core specimen. Due to unavailable molecular/cytogenetic diagnostics in Malawi, patients with \<20% bone marrow myeloblasts can be included in the study at the discretion of the treating oncologist with rationale documented. * In cases where a bone marrow evaluation is not safe/feasible, a peripheral blood sample may be used with a documented absolute myeloblast percentage of โ‰ฅ1000/ฮผL calculated based on a total white blood cell count and percentage circulating blasts. 3. Therapy Patients must begin treatment according to the 2023 KCH AML therapy CPG. Exclusion Criteria: 1. Patients with any of the following conditions or criteria will be excluded from the study: * Juvenile myelomonocytic leukemia * Transient myeloproliferative disorder * Acute promyelocytic leukemia * Mixed phenotype acute leukemia * Trisomy 21 * Current pregnancy * Previous or concurrent malignancy * Isolated myeloid sarcoma 2. Patients previously treated with antineoplastic therapy with the following exceptions: * Hydroxyurea * Corticosteroids * Intrathecal chemotherapy at diagnosis
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What it tests

  • Intensity-adapted pediatric acute myeloid treatment guidelines
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Where

1 site
Kamuzu Central Hospital
Lilongwe, Malawi
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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