Evaluating treatment protocols for pediatric acute myeloid leukemia in Malawi
Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi
This study is testing a new treatment plan for children with acute myeloid leukemia in Malawi to see if it can help them survive better and handle side effects more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lilongwe, Lilongwe) |
| Trial ID | NCT06928909 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children under 18 diagnosed with acute myeloid leukemia (AML) at Kamuzu Central Hospital in Malawi. It aims to assess the implementation of the International Society of Paediatric Oncology's (SIOP) clinical practice guidelines for AML treatment in a resource-constrained setting. By adopting an intensity-adapted treatment protocol, the study seeks to improve survival rates and manage treatment toxicity effectively. Data will be collected as part of routine clinical care, ensuring a comprehensive evaluation of patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old diagnosed with de novo AML at Kamuzu Central Hospital.
Not a fit: Patients with chronic or relapsed forms of leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates for pediatric AML patients in low-resource settings.
How similar studies have performed: Other studies in resource-limited settings have shown promising results with similar treatment protocols, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥20%. 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 ≥1000/μL 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
Where this trial is running
Lilongwe, Lilongwe
- Kamuzu Central Hospital — Lilongwe, Lilongwe, Malawi (Recruiting)
Study contacts
- Principal investigator: Casey McAtee, M.D., M.P.H. — Baylor College of Medicine
- Study coordinator: Casey McAtee, M.D., M.P.H.
- Email: casey.mcatee@bcm.edu
- Phone: +1 251-605-5370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.