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New treatment option for Graft Versus Host Disease
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
ClinicalTrials.gov ID: NCT06252870
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, being studied as a potential treatment for graft versus host disease.
Also referred to as MTX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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...
- Progressive psychiatric condition
- Pregnant or breastfeeding woman,
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Brest, France
- Nantes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Brest, France; Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.