NCT06252870 Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
| NCT ID | NCT06252870 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nantes University Hospital |
| Condition | Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2027-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 82 participants in total. It began in 2024-07-18 with a primary completion date of 2027-10-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (allo-CSH). Recently, in the context of semi-identical (=haploidentical) HLA donors, but also of compatible HLA donors, the use of cyclophosphamide (CY) administered in high doses at early post-transplant (PT) (=PTCY) (Days +3 and +4 or +5) has shown excellent control of acute and chronic GVH, even enabling the discontinuation of other immunosuppressive drugs administered after allo-CSH (ciclosporin, mycophenolate mofetyl (MMF) or Cellcept). This step has already been taken in the context of allo-CSH with myeloablative conditioning (MAC), which is a minoritary conditioning in adults. However, in the context of allo-CSH with reduced-intensity conditioning (RIC), which predominates in adults, this strategy seems insufficient to prevent the risk of GVHD. The idea of reducing the use of immunosuppressants in the context of RIC/HLA-compatible transplants seems, however, still relevant, in order to reduce their adverse effects, improve patients' quality of life and enhance the reconstitution of the post-transplant immune system.
Eligibility Criteria
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
Contact & Investigator
Sylvain THEPOT, MD
PRINCIPAL INVESTIGATOR
University Hospital, Angers
Frequently Asked Questions
Who can join the NCT06252870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Graft Versus Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06252870 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06252870 currently recruiting?
Yes, NCT06252870 is actively recruiting participants. Contact the research team at amandine.lebourgeois@chu-nantes.fr for enrollment information.
Where is the NCT06252870 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Nantes, France.
Who is sponsoring the NCT06252870 clinical trial?
NCT06252870 is sponsored by Nantes University Hospital. The principal investigator is Sylvain THEPOT, MD at University Hospital, Angers. The trial plans to enroll 82 participants.