Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New trial aims to tame transplant complications in blood cancer patients

NCT ID NCT04888741

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tests different drug combinations to prevent graft-versus-host disease (GVHD) in 400 blood cancer patients receiving stem cell transplants from unrelated donors. Participants will receive either thymoglobulin or a combination of cyclophosphamide with other immunosuppressants. The goal is to find which approach best prevents GVHD while avoiding relapse, improving overall survival.

What this could mean

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

Active substance
Thymoglobulin, cyclophosphamide, cyclosporine, sirolimus, mycophenolate mofetil
What this could lead to
If successful, this could identify a safer, more effective way to prevent graft-versus-host disease after stem cell transplants, improving survival and quality of life for blood cancer patients.
What could go wrong
This is a phase II trial, so results are preliminary. The drugs have known side effects like infection risk and organ damage, and the best regimen may still not prevent GVHD in all patients.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 400 people

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

Started

Feb 2021

Expected to finish

Aug 2027

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 70 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: * Availability of suitably matched unrelated donor (9/10 or 10/10) * Planned to receive one of the following RIC protocols: * Fludarabine-Melphalan (Fludarabine 120-180mg/m2 IV; melphalan ≤ 150mg/m2 IV) * BEAM or LEAM (carmustine 300mg/m2 IV or lomustine 200mg/m2 IV with: etoposide 800 mg/m2 IV; cytarabine 1600mg/m2 IV; melphalan 140mg/m2 IV) * Fludarabine-Busulphan (Fludarabine 120-180mg/m2 IV; Busulphan ≤ 8mg/kg PO or 6.4mg/kg IV) * Fludarabine- Treosulfan (Fludarabine 150mg/m2 IV; Treosulfan 30g/m2 IV) * Planned use of PBSCs for transplantation * Planned allo-SCT for one of the following haematological malignancies: * AML in CR (patients enrolled onto the COSI trial are not eligible for this study) * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study) * CMML \<10% blasts * MDS \<10% blasts (patients enrolled onto the COSI trial are not eligible for this study) * NHL in CR/PR * HL in CR/PR * MM in CR/PR * CLL in CR/PR * CML in 1st or 2nd chronic phase * Myelofibrosis * Age 16-70 years * 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: * Use of any method of graft manipulation (excluding storage of future DLI) * Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined * Known hypersensitivity to study drugs or history of hypersensitivity to rabbits * Pregnant or lactating women * Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period * Life expectancy \<8 weeks * Active HBV or HCV infection * Organ dysfunction defined as: * LVEF \<45% * GFR \<50ml/min * Bilirubin \>50µmol/l * AST/ALT\>3 x ULN * Participation in COSI or ALL-RIC trials * Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC. * Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

    17 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

  • Addenbrookes Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Hammersmith Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • King's College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Nottingham City Hospital

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Queen Elizabeth Hospital Glasgow

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S102JF, United Kingdom

  • St Jame's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • The Christie

    RECRUITING

    Manchester, M20 3QH, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • University College London Hospital

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, Wales, CF14 4XW, United Kingdom

More trials for these conditions

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