Evaluating treatment protocols for pediatric acute myeloid leukemia in Malawi

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AMX-883 in AML and high-risk MDS: a first-in-class dosing study

  This early-stage study tests AMX-883 alone and with another drug to see if it is safe and shows early signs of benefit in people with AML or high-risk MDS.

  Recruiting at 3 sites Phase 1 Amphista Therapeutics Ltd · New York, New York and 2 other locations · NCT07723703

• AZD3632, alone or with other anticancer agents, for advanced blood cancers driven by HOX overexpression

  This trial will test whether the oral drug AZD3632, given alone or with the antifungal posaconazole, is safe and helps control relapsed or refractory AML, ALL, or high-risk MDS that have KMT2A rearrangements, NPM1 mutations, or other genotypes causing HOX overexpression.

  Recruiting at 20 sites Phase 1/2 AstraZeneca · Decatur, Illinois and 29 other locations · NCT07155226

• U32 CAR-T for acute myeloid leukemia

  This will test whether U32 CAR-T is safe and can help people aged 2–65 with relapsed or refractory acute myeloid leukemia.

  Recruiting Phase 1/2 Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Suzhou · NCT07036250

• Monalizumab treatment for patients with blood cancers undergoing stem cell transplantation

  This study is testing if a new treatment called Monalizumab can help people with blood cancers like AML or MDS who are getting stem cell transplants by improving their immune response and reducing the chances of disease returning or complications.

  Recruiting at 2 sites Phase 2 Istituto Clinico Humanitas · Genova, GENOVA and 1 other locations · NCT06892223

• HPV vaccination after allogeneic stem cell transplant

  This trial will test whether giving the 9‑valent HPV vaccine early or later after an allogeneic stem cell transplant produces a protective antibody response in adults up to age 45 who had a transplant.

  Recruiting at 3 sites Phase 2 Vastra Gotaland Region · Lund, Region Skåne and 4 other locations · NCT06793410

• New treatment approach for newly diagnosed Acute Myeloid Leukemia

  This study is testing a new combination treatment for people with newly diagnosed Acute Myeloid Leukemia to see if it works better than the usual chemotherapy.

  Recruiting Phase 3 Zhongnan Hospital · Zhengzhou, Henan and 10 other locations · NCT06345365

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.