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

Launched by NANTES UNIVERSITY HOSPITAL · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment plans to help prevent a serious complication called graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from a donor. GVHD can occur when the donated cells attack the recipient’s body, leading to various health issues. The trial uses a medication called cyclophosphamide to see if it can effectively reduce GVHD symptoms without needing other immunosuppressive medications that can have side effects. The goal is to improve the patients' quality of life and support their immune system recovery after the transplant.

To participate in this study, patients should be between 18 and 70 years old, have a blood cancer, and be eligible for a specific type of stem cell transplant that uses reduced intensity conditioning. They will also need to have a compatible donor available. Participants can expect to receive close monitoring throughout the trial to ensure their safety and well-being. It's important for potential participants to understand that they must follow specific guidelines, such as using effective birth control during the treatment period, to ensure the study's reliability and safety.

Gender

ALL

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