Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06252870 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: CY-MET-RIC
StatusRecruiting
PhasePhase 2
Started2024-07-18
View on ClinicalTrials.gov ↗

Amendment history

2026-01-23
Study Status v4
Re-verified, no change to tracked fields
2024-10-24
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 3 sites
2024-07-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-09-15→2027-10-18
Completion date2028-05-15→2028-07-18
Start dateestimated 2024-05-15→confirmed 2024-07-18
Study sites0→3
2024-04-08
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Enrollment target60→82
Eligibility criteria+316 characters
[...] onths 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 aff [...] sive cancerous disease, or antecedent of cancer in the last twofive years, with the exception of a carcinoma of the skin or a carcinoma in situ of the cervixuterine cole treated and in remission. Progressive psychiatric condition [...] year Known or suspected hypersensitivity to rabbit proteins. as [...] [...]
Secondary endpoints12 to 13 entries
Incidence of corticoresistant acute GVHD
Primary endpoints1 entry, revised
Incidence of corticoresistant grade 3-4 acute GVHD following allo-CSH for all patients and for each conditioning group (Baltimore and TBF).
2024-02-01
Original filing
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.
Trial Details
NCT Number NCT06252870
Lead Sponsor Nantes University Hospital
Conditions Graft Versus Host Disease, Hematologic Malignancy
Enrollment 82 participants
Start Date 2024-07-18
Primary Completion 2027-10-18 (estimated)
Study Completion 2028-07-18 (estimated)
Updated on ClinicalTrials.gov 2026-01-26