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Randomized Phase 2 study testing two conditioning regimen with a single prophylaxis of graft-versus-host disease by cyclophosphamide and methotrexate post-transplant in patients eligible for matched-donor allograft transplantation _ CY-MET-RIC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509042-35-01
Acronym
RC23_0286
Enrollment
82
Registered
2024-04-08
Start date
2024-07-18
Completion date
Unknown
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults patients will be included in the hematology departments. Eligible patients will be those scheduled to receive an allo-HSC after a RIC conditioning regimen for a myeloid or lymphoid hematological malignancy with a family or non-family HLA-matched donor 10/10

Brief summary

The incidence of corticoresistant grade 3 and 4 acute GVH following allo-HSC according to Mount Sinai criteria. Corticoresistance is assessed according to the criteria of Mohty et al and defined as either -> after 5 to 7 days of 2 mg/kg systemic corticosteroids: worsening or non-improvement of GVH -> after 14 days of 2 mg/kg systemic corticosteroids: absence of complete remission of GVHD. Corticoresistant acute GVH following DLI injection will be excluded

Detailed description

Graft uptake assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and red cell concentrate transfusions), OS at 1 year and last follow-up (survival between day 0 of transplantation and date of death or last follow-up), DFS at 1 year and last follow-up (survival from day 0 of transplantation to date of relapse, death or last follow-up), GRFS at 1 year and last follow-up (relapse-free survival without grade 3-4 acute GVH or chronic GVH requiring systemic treatment), Acute GVHD grade 2-4 according to Mount Sinai criteria, Chronic GVHD according to NCI criteria, NRM: any death unrelated to relapse or disease progression at 1 year and last follow-up, Relapse: any documented disease recurrence at 1 year and last follow-up, Total donor or mixed chemism at M1, M2, M3, M6, M12. Total donor chimerism = result >95% donor CD3+ and CD34+ cells. Mixed chimerism = result > 5% and < 95% donor CD3+ cells (routine test), Immune reconstitution at M3, M6, M9, M12: lymphocyte, monocyte, T4, T8, NK and B cell counts (routine examination), Grade 3 and 4 post-transplant adverse events (dates of occurrence) (NCI CTCAE version 5 criteria), Infections: viral (CMV, EBV, BKV, adenovirus), bacteriological, fungal and parasitic

Interventions

DRUGMETHOTREXATE
DRUGFLUDARABINE
DRUGTHIOTEPA
DRUGCYCLOPHOSPHAMIDE
DRUGBUSULFAN
DRUGCLOFARABINE

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The incidence of corticoresistant grade 3 and 4 acute GVH following allo-HSC according to Mount Sinai criteria. Corticoresistance is assessed according to the criteria of Mohty et al and defined as either -> after 5 to 7 days of 2 mg/kg systemic corticosteroids: worsening or non-improvement of GVH -> after 14 days of 2 mg/kg systemic corticosteroids: absence of complete remission of GVHD. Corticoresistant acute GVH following DLI injection will be excluded

Secondary

MeasureTime frame
Graft uptake assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and red cell concentrate transfusions), OS at 1 year and last follow-up (survival between day 0 of transplantation and date of death or last follow-up), DFS at 1 year and last follow-up (survival from day 0 of transplantation to date of relapse, death or last follow-up), GRFS at 1 year and last follow-up (relapse-free survival without grade 3-4 acute GVH or chronic GVH requiring systemic treatment), Acute GVHD grade 2-4 according to Mount Sinai criteria, Chronic GVHD according to NCI criteria, NRM: any death unrelated to relapse or disease progression at 1 year and last follow-up, Relapse: any documented disease recurrence at 1 year and last follow-up, Total donor or mixed chemism at M1, M2, M3, M6, M12. Total donor chimerism = result >95% donor CD3+ and CD34+ cells. Mixed chimerism = result > 5% and < 95% donor CD3+ cells (routine test), Immune reco

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026