Leukemia Adapted Protocol

Launched by BAYLOR COLLEGE OF MEDICINE · Apr 8, 2025

Keywords

ClinConnect Summary

The Leukemia Adapted Protocol (LEAP) study is focused on improving treatment outcomes for children with acute myeloid leukemia (AML) in Malawi, where survival rates are much lower than in wealthier countries. This trial is evaluating a new treatment guideline designed for resource-limited settings, which aims to provide effective treatment while managing side effects. The Kamuzu Central Hospital has started using these guidelines, and the LEAP study will monitor how well they work in real-life situations. Researchers will look at how feasible it is for patients to follow the treatment plan and whether it leads to successful remission, meaning the cancer is no longer detectable.

To participate in the study, children under 18 years old must be diagnosed with AML and start treatment according to the new guidelines. Researchers will gather information on various outcomes, including how well patients respond to treatment, any side effects they experience, and how treatment affects their quality of life. This study is important as it will be the first of its kind in sub-Saharan Africa, providing valuable insights that could help improve cancer care for children in similar settings around the world.

Gender

ALL

Eligibility 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