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Could white blood cells boost cord transplants for tough leukemia?

NCT ID NCT07372885

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This trial tests a new way to do cord blood transplants for young adults (ages 16-55) with very poor risk acute myeloid leukemia (AML). Participants get a standard cord blood transplant plus daily infusions of white blood cells called granulocytes for 1 to 7 days. The goal is to see if this combination is safe and can reduce the chance of the leukemia coming back. The study has two parts: first to find the best dose, then to see if it works better than standard transplant.

What this could mean

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

Active substance
cord blood stem cells and granulocytes (white blood cells)
What this could lead to
If successful, this approach could offer a more effective transplant option for young adults with hard-to-treat AML, potentially reducing relapse and improving survival.
What could go wrong
This is an early phase I/II trial with only 50 participants, so results may not apply broadly. The granulocyte infusions can cause fever, rash, and other side effects, and the treatment may not work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

16 to 55 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. Availability of a suitable cord blood unit 2. Age between 16 and 55 years 3. Primary diagnosis of Acute Myeloid Leukaemia (AML) or MDS/AML (as defined by ICC 2022) fitting one or more of the following criteria: * TP53 mutation (single- or multi-hit) * Presence of inv(3) (q21.3q26.2) or t(3;3)(q21.3;q26.2) * Adverse risk (as per ICC 2022) and \>0.1% MRD by flow cytometry after 2 cycles of induction * AML (any risk) with partial remission (\<10% blasts) after 2 cycles induction * Early relapse (\<6 months) after chemotherapy alone (excluding t(16;16), inv(16) or t(8;21)) 4. Bone marrow performed within 28 days of starting conditioning chemotherapy demonstrates either: * \<10% blasts * \>10% blasts with a hypocellular background (must be discussed with the trial team) 5. Suitable fitness and organ function as per the following criteria: * Glomerular filtration rate \>50 mL/min/1.73m2 * Ejection fraction \>50% * FEV1 \>65% without dyspnoea on mild activity * AST/ALT \<3 x ULN * Bilirubin \<1.5 x ULN (excluding Gilbert's syndrome) * Performance Status (ECOG) of 0 or 1 6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant EXCLUSION CRITERIA: 1. AML Secondary to a myeloproliferative neoplasm 2. Active CNS disease 3. Prior allogeneic stem cell transplant 4. Participation in another clinical trial that would alter any aspect of the transplant protocol or that aims to reduce the subsequent risk of relapse (discuss with trial team if unsure) 5. History of cardiac arrhythmia 6. Ischaemic heart disease, valvular heart disease or congestive cardiac failure 7. Transient ischaemic attack or cerebrovascular accident 8. Rheumatologic disease (SLE, RA, polymyositis, mixed CTD or polymyalgia rheumatica) 9. Ulcerative colitis or Crohn's disease 10. Liver cirrhosis 11. Presence of an active second malignancy 12. Uncontrolled infection, including viral reactivation (CMV, EBV) 13. HIV positive 14. Hepatitis B/C active infection with measurable viral load (patients with chronic hepatitis B or C infection require clear documentation of absence of cirrhosis by either fibroscan or biopsy, regardless of viral load) 15. Pregnancy, breastfeeding, unwilling to use contraception 16. Contraindications to administration of pooled granulocytes 17. Previous history of sensitivity to granulocytes 18. Inability of patient to give informed consent 19. Any other organ dysfunction or co-morbidity that precludes transplant in the opinion of the investigator 20. Any concern by PI

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Myelodysplastic Syndromes

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Kings College Hospital NHS Trust

    London, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Royal Marsden Hospital NHS Foundation Trust

    London, United Kingdom

More trials for these conditions

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