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Could extra white cells boost immune recovery in kids with tough leukemia?

NCT ID NCT05425043

Disease control Sponsor: University of Manchester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether giving children with hard-to-cure leukemia a transfusion of white blood cells (granulocytes) after a cord blood transplant helps their new immune system grow faster and safer. About 40 children under 16 will receive this extra transfusion, and researchers will check for side effects like cytokine release syndrome and whether the treatment helps control leukemia without causing graft-versus-host disease. The goal is to improve recovery and reduce complications in kids who need a transplant.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Started

Sep 2021

Expected to finish

Jun 2026

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

Up to 16 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. Children, aged \<16 years, undergoing a first allogeneic, unrelated donor, T-cell replete, umbilical cord blood HSCT for high risk acute leukaemia. 2. Availability of at least a 6/8 allelic matched cord blood, of adequate cell dose, after allele-level matching at HLA (Human Leukocyte Antigen)-A, -B, -C, and -DRB1 3. Informed consent by parent or guardian. Age appropriate Assent will also be collected in those Children age 16 and under. Exclusion Criteria: 1. Patients participating in other HSCT clinical trial 2. The transplant not indicated according to National Health Service England (NHSE) and British Society of Bone Marrow Transplant (BSBMT) Paediatric Transplant Group. 3. Pooled Granulocyte Transfusion contraindicated for any reason 4. Previous T cell replete unrelated donor cord blood transplant 5. Patients with a previous history of sensitivity to granulocyte transfusion will be excluded from the study

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm leukemia neoplasm

As listed by the trial registrant

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

Pediatric cancer

Contacts and locations

Locations

  • Royal Manchester Childrens Hospital, MFT

    Manchester, M13 9WL, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.