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New hope for kids with leukemia in malawi: adapted treatment shows promise

NCT ID NCT06928909

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study looks at whether a special treatment plan for children with acute myeloid leukemia (AML) can work well in Malawi, where resources are limited. About 30 children under 18 will receive a treatment guideline designed to balance curing the disease with manageable side effects. The goal is to see if most children can complete the treatment and achieve remission, while also tracking their quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kamuzu Central Hospital

    RECRUITING

    Lilongwe, Lilongwe, Malawi

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