Status:
RECRUITING
Leukemia Adapted Protocol
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
American Society of Hematology
Conditions:
Acute Myeloid Leukaemia
Eligibility:
All Genders
Up to 18 years
Brief Summary
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...
Detailed Description
Participants: * All patients with have de novo AML presenting to Kamuzu Central Hospital (KCH) in Lilongwe, Malawi will be offered enrollment into the study. * Patients must be \<18 years of age at t...
Eligibility Criteria
Inclusion
- Age Patients must be \<18 years of age at time of study enrollment.
- 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.
- Therapy Patients must begin treatment according to the 2023 KCH AML therapy CPG.
Exclusion
- 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
- Patients previously treated with antineoplastic therapy with the following exceptions:
- Hydroxyurea
- Corticosteroids
- Intrathecal chemotherapy at diagnosis
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06928909
Start Date
January 1 2025
End Date
December 31 2030
Last Update
April 15 2025
Active Locations (1)
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1
Kamuzu Central Hospital
Lilongwe, Lilongwe, Malawi