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New cell cocktail aims to prevent transplant complications in kids with leukemia

NCT ID NCT07366801

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new method to prevent graft-versus-host disease (GVHD) in children and young adults with high-risk blood cancers who need a stem cell transplant from a half-matched donor. The approach combines specially enriched donor immune cells with a stem cell graft that has most T cells removed, along with reduced use of immune-suppressing drugs. The goal is to lower the risk of severe GVHD while keeping the immune system strong enough to fight infections.

What this could mean

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

Active substance
Donor lymphocytes enriched with regulatory T cells, combined with a stem cell graft that has had most T cells removed
What this could lead to
If successful, this approach could reduce the risk of severe graft-versus-host disease while preserving the immune system's ability to fight infections after a stem cell transplant.
What could go wrong
This is an early pilot study with only 64 participants, so results may not apply to all patients. There is still a risk of graft-versus-host disease or serious infections.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 64 people

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

Started

Sep 2025

Expected to finish

Feb 2028

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 year to 25 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. Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years). 2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework 3. Planned HSCT from a haploidentical donor 4. The Karnofsky or Lansky score is more than 70% 5. Life expectancy of at least 8 weeks 6. Heart function: ejection fraction of at least 40% 7. Consent to continue follow-up for 3 years Exclusion Criteria: 1. Acute viral hepatitis or acute HIV infection 2. Hypoxemia with SaO2 \<90% 3. Bilirubin \>3 normal 4. Creatinine \>3 norms 5. Pregnancy and lactation 6. Life-threatening infection 7. Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system) 8. Karnofsky score or Lansky score \<70%

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence graft versus host disease prevention target

As listed by the trial registrant

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

Acute lymphoblastic leukemia, high risk Acute lymphoblastic leukemia, relapse Acute myeloid leukemia, high risk Acute myeloid leukemia, relapsed

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