Actively Recruiting
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
Led by Nantes University Hospital · Updated on 2026-01-26
82
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosed with hematologic malignancy
- Eligible for hematopoietic stem cell allograft with reduced-intensity (attenuated) conditioning
- Pluripotent stem cell engraftment expected
- Availability of a 10/10 matched familial or non-familial HLA compatible donor
- Provided informed consent for the protocol
- ECOG performance status of 2 or less
- Women of childbearing age with a negative pregnancy test and using highly effective contraception during treatment and for 12 months after stopping methotrexate and cyclophosphamide
- Men of childbearing age using highly effective contraception during treatment and for 6 months after stopping methotrexate and cyclophosphamide, or 12 months if assigned to the TBF conditioning regimen
- Negative serology for Hepatitis B, Hepatitis C, and HIV
- Affiliated with social security
You will not qualify if you...
- Previous allogeneic stem cell transplant
- Eligible for myeloablative conditioning (MAC)
- History of bone marrow transplant
- Other active or progressive cancer or cancer within the past 5 years, except treated and in remission skin carcinoma or carcinoma in situ of the uterine cervix
- Progressive psychiatric condition
- Pregnant or breastfeeding women
- Lack of effective contraception in women or men of childbearing age
- Serious uncontrolled infection
- Heart problems: systolic ejection fraction below 50%, NYHA class II-IV heart failure, active heart rhythm, valve or ischemic disease
- Lung function with DLCOc less than 40% of predicted
- Kidney function with creatinine clearance less than 50 ml/min
- Active urinary tract infection, history of acute urothelial toxicity from chemotherapy or radiotherapy, urinary flow obstruction, or pre-existing hemorrhagic cystitis
- Liver function with transaminases greater than 5 times normal or bilirubin greater than 2 times normal
- Legal protection status (guardianship, curatorship, or legal protection)
- Yellow fever vaccination within the last year
- Known allergy to rabbit proteins or any drugs used in the study
- Contraindication to any investigational or supportive drugs in the study
- Inability to speak French
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Trial Site Locations
Total: 3 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU Brest
Brest, France
Actively Recruiting
3
CHU Nantes
Nantes, France
Actively Recruiting
Research Team
A
Amandine LE BOURGEOIS, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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