Leukemia Adapted Protocol
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 assess the implementation of the SIOP AML guidelines at KCH in an effort to continually improve outcomes in Malawi. The study is an observational-implementation design with a composite effectiveness-implementation outcome called Implementation Success. Implementation Success combines feasibility, the ability of patients to complete all aspects of the CPG, with effectiveness, the ability to maintain historical rates of complete remission of 40% at the treatment center. This prospective cohort study will enroll children under 18 years diagnosed with de novo AML at KCH. Implementation Success will be the primary endpoint, with secondary endpoints including CPG fidelity, long-term survival, adverse events, and hematologic recovery times. Patient-reported outcomes will also be collected to assess the impact of treatment on quality of life. This will be the first prospective study of pediatric AML in sub-Saharan Africa, providing critical data on the management of AML in low-resource settings. By assessing the implementation of a context-adapted CPG, the study will contribute to the global effort to improve pediatric AML outcomes in resource-constrained environments. The findings will serve to guide practitioners in Malawi and similar settings, and the data generated will be invaluable for future clinical decisions and CPG development.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek poniżej 18 lat w momencie włączenia do badania
- •Nowo rozpoznana białaczka mieloblastyczna (AML) wg klasyfikacji WHO 2022
- •Co najmniej 20% blastów (komórek nowotworowych) w szpiku kostnym lub co najmniej 1000 blastów na mikrolitr krwi
- •Rozpoczęcie leczenia zgodnie z protokołem szpitala KCH
✗ Disqualifies
- •Inne typy białaczek lub zaburzenia mieloproliferatywne (JMML, zaburzenia przejściowe, białaczka promieloblastyczna)
- •Białaczka mieszanego fenotypu
- •Zespół Downa (trisomia 21)
- •Ciąża
- •Wcześniejszy lub obecny inny nowotwór
- •Wyizolowany guz mieloidalny
- •Wcześniejsze chemioterapię (poza hydroksyureą, kortykosteroidami i chemią donosową)
Simplified criteria — AI translation
Trial details
- Maximum age
- 18 Years
- Last updated (source)
- July 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Kamuzu Central Hospital
Lilongwe, Malawi
Trial contact
Casey McAtee, M.D., M.P.H.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/16/2026.
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