Leukemia Adapted Protocol

NCT06928909 | Recruiting

• 1 other identifier: H-53055
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Myeloid Leukaemia

Keywords

Pediatric Acute Myeloid Treatment; Acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes (1)

• Determine the implementation success of an intensity adapted clinical practice guideline (CPG) based upon recommendations by the International Society of Paediatric Oncology (SIOP) for childhood AML in resource limited settings.

  CPG Implementation Success will be a composite endpoint comprised of: 1. Feasibility: proportion of patients completing the CPG. (see Study Design for further details outlining CPG completion criteria) 2. Effectiveness: proportion of patients in complete remission (CR) by the end of Induction 2 chemotherapy.

  From initiation of chemotherapy to assessment of completion of the CPG and attainment of end-of-induction bone marrow evaluation (if CPG completed to that point), assessed up to 12 months from the start of chemotherapy.

Secondary Outcomes (10)

• Estimate the proportion of patients with negative minimal residual disease (MRD) following Induction

  By end of second induction, assessed up to 6 months from initiating chemotherapy.

• Estimate the proportion of patients with early mortality

  Assessed up to 42 days from start of chemotherapy

• Estimate the proportion of patients with treatment-related mortality on the CPG

  Assessed from Day 43 following initiation of chemotherapy through to completion of the CPG, assessed up to 12 months.

• Estimate the proportion of patients with serious adverse events

  From initiation of chemotherapy through to completion of the CPG, assessed up to 12 months.

• Estimate the time to hematologic recovery following cycles of chemotherapy

  From the final dose of curative-intent chemotherapy to blood product independence, assessed up to 6 months.

Study Arms (1)

All patients with de novo AML

All patients with de novo AML presenting to Kamuzu Central Hospital in Lilongwe, Malawi will be offered enrollment into the study.

Other: Intensity-adapted pediatric acute myeloid treatment guidelines

Interventions

Intensity-adapted pediatric acute myeloid treatment guidelines OTHER

This is an observational study evaluating the current standard of care AML therapy in Malawi. The therapy guideline used is an adaptation of the International Society of Paediatric Oncology (SIOP) guidelines for pediatric AML in resource-constrained centers published by the International Society of Paediatric Oncology (SIOP). It is currently the standard of care in Malawi for all patients with AML. Receipt of this therapy guideline is independent of participation in research.

All patients with de novo AML

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients with de novo AML presenting to Kamuzu Central Hospital in Lilongwe, Malawi.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• American Society of Hematology: collaborator

Study Sites (1)

Kamuzu Central Hospital

Lilongwe, Lilongwe, Malawi

RECRUITING

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MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Casey McAtee, M.D., M.P.H.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey McAtee, M.D., M.P.H.

CONTACT

+1 251-605-5370; casey.mcatee@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 15, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)