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New chemo regimen aims to boost survival in kids with down syndrome and leukemia

NCT ID NCT07232134

Disease control Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a specific set of four chemotherapy blocks in children (0-18 years) who have both acute myeloid leukemia (AML) and Down syndrome. The goal is to see if this tailored treatment can improve long-term survival and reduce harsh side effects compared to past approaches. The trial is enrolling 100 participants across multiple centers in Russia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (cytarabine, idarubicin, etoposide, daunorubicin)
What this could lead to
If successful, this could establish a safer, more effective chemotherapy regimen for children with both AML and Down syndrome, improving survival rates and reducing toxic side effects.
What could go wrong
This is a non-randomized trial with no control group, so results may be less definitive. Chemotherapy carries significant risks like infection and organ damage, and the reduced doses might not control the leukemia as well as standard treatment.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

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

Started

Jul 2025

Expected to finish

Dec 2032

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.

Ages

1 day 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: * Age 0-18 years * Diagnosis of AML, MDS and presence of Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene) * Signed informed consent Exclusion Criteria: * Children with Down syndrome and acute lymphoblastic leukemia (ALL) * Severe comorbidities with contraindications to the treatment according to the protocol * Pre-treatment \>14 days with intensive induction therapy * Refusal of all therapy or important elements of therapy

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Down syndrome

As listed by the trial registrant

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

AML (acute myelogenous leukemia) Down syndrome (DS)

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

  • National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198

    RECRUITING

    Moscow, Russia

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