New hope for stem cell transplant patients: simpler drug combo may reduce severe side effects
NCT ID NCT06252870
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two different pre-transplant conditioning plans combined with a single drug combination (cyclophosphamide and methotrexate) to prevent graft-versus-host disease (GVHD) in blood cancer patients receiving a stem cell transplant from a matched donor. About 82 adults aged 18-70 will take part. The goal is to see if this approach can reduce severe GVHD while allowing fewer long-term immune-suppressing drugs.
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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 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2028
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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18 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: * Age: ≥ 18 and ≤ 70 years old * Patient with hematologic malignancy * Indication for HSC allograft with attenuated conditioning * Pluripotent stem cell (PSC) engraftment * Availability of a 10/10 familial or non-familial HLA compatible donor * Consent to the protocol * ECOG \<=2 * Woman of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for a period of 12 months after stopping MTX and CY * Man of childbearing age with highly effective contraception during treatment and for a period of 6 months after stopping MTX and CY and a period of 12 months after stopping MTX and CY if TBF conditioning regimen arm * Negative Hepatitis B, C, HIV serologies * Social security affiliation Exclusion Criteria: * History of allograft * Patient eligible for myeloablative conditioning (MAC) * Bone marrow transplant * Other progressive cancerous disease, or antecedent of cancer in the last five years, with the exception of a carcinoma of the skin or a carcinoma in situ of the uterine cole treated and in remission. * Progressive psychiatric condition * Pregnant or breastfeeding woman, * Woman or man of childbearing age with lack of effective contraception * Serious and uncontrolled concomitant infection * Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or by isotopic method (isotope gamma angiography), NYHA II, III or IV heart failure, active rhythmic, valvular or ischemic heart disease or anteriority * Respiratory with EFR: DLCOc \<40% of theoretical * Renal: creatinine clearance \< 50 ml/min (assessment with MDRD method) * Urological: active urinary tract infection, history of acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy, known obstruction of urinary flow, pre-existing hemorrhagic cystitis * Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal * Person protected by law (major under guardianship, curatorship or legal protection) * Vaccination against yellow fever in the last year * Known or suspected hypersensitivity to rabbit proteins as well as to the active substance and excipients of all investigational and ancillary drugs administered during the study, * Contraindication to any of the investigational or adjuvant drugs administered during the study * Patient not speaking French
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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
3 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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CHU Angers
RECRUITINGAngers, France
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CHU Brest
RECRUITINGBrest, France
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CHU Nantes
RECRUITINGNantes, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can adding rituximab improve remission in chronic GVHD?
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?