New trial aims to tame transplant complications in blood cancer patients
NCT ID NCT04888741
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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16 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Addenbrookes Hospital
RECRUITINGCambridge, CB2 0QQ, United Kingdom
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Bristol Haematology and Oncology Centre
RECRUITINGBristol, BS2 8ED, United Kingdom
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Churchill Hospital
RECRUITINGOxford, OX3 7LE, United Kingdom
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Derriford Hospital
RECRUITINGPlymouth, PL6 8DH, United Kingdom
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Freeman Hospital
RECRUITINGNewcastle upon Tyne, NE7 7DN, United Kingdom
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Hammersmith Hospital
RECRUITINGLondon, W12 0HS, United Kingdom
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King's College Hospital
RECRUITINGLondon, SE5 9RS, United Kingdom
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Manchester Royal Infirmary
RECRUITINGManchester, M13 9WL, United Kingdom
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Nottingham City Hospital
RECRUITINGNottingham, NG5 1PB, United Kingdom
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Queen Elizabeth Hospital
RECRUITINGBirmingham, B15 2GW, United Kingdom
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Queen Elizabeth Hospital Glasgow
RECRUITINGGlasgow, G51 4TF, United Kingdom
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Royal Hallamshire Hospital
RECRUITINGSheffield, S102JF, United Kingdom
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St Jame's University Hospital
RECRUITINGLeeds, LS9 7TF, United Kingdom
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The Christie
RECRUITINGManchester, M20 3QH, United Kingdom
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The Royal Marsden Hospital
RECRUITINGSutton, SM2 5PT, United Kingdom
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University College London Hospital
RECRUITINGLondon, NW1 2BU, United Kingdom
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University Hospital of Wales
RECRUITINGCardiff, Wales, CF14 4XW, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders