רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT06252870 (CY-MET-RIC) עבור מחלת השתל נגד המאכסן, ממאירות המטולוגית הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
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 (CY-MET-RIC) שלב II 82
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT06252870 (CY-MET-RIC) מתקיים כדי לבדוק את טיפול עבור מחלת השתל נגד המאכסן, ממאירות המטולוגית. זהו מחקר שלב II מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-18 ביולי 2024 ומתוכנן לכלול 82 משתתפים. המחקר מנוהל על ידי Nantes University Hospital וצפוי להסתיים ב-18 ביולי 2028. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-26 בינואר 2026.
סיכום קצר
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...
הצג עודתיאור מפורט
For this reason, the investigators now wish to test the administration of a combination of a high dose of early post-transplant CY (PTCY) and methotrexate (MTX) on days (D) D+1, D+4, D+6, D+11 (doses already performed in MAC transplant prophylaxis), with anti-lymphocyte serum (ALS) with RIC conditioning, without ciclosporin or MMF.
The investigators hypothesize that administration of this PTCY+MTX combination will e...
הצג עודכותרת רשמית
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
מצבים רפואיים
מחלת השתל נגד המאכסןממאירות המטולוגיתמזהי מחקר נוספים
- CY-MET-RIC
- RC23_0286
מספר NCT
תחילת המחקר (בפועל)
2024-07-18
עדכון אחרון שפורסם
2026-01-26
סיום המחקר (מוערך)
2028-07-18
משתתפים (מתוכנן)
82
סוג המחקר
התערבותי
שלב
שלב II
סטטוס
מגייס
מילות מפתח
Hematopoietic stem cell allograft (Allo-CSH)
Methotrexate (MTX)
Post-transplant cyclophosphamide (PTCY)
Methotrexate (MTX)
Post-transplant cyclophosphamide (PTCY)
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסי(CLO)-BALTIMORE BALTIMORE conditioning regime for LYMPHOID HEMOPATHY CLO-BALTIMORE conditioning regime for MYELOID HEMOPATHY | Methotrexate 15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0) Post-Transplant Cyclophosphamide 50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0) פלודרבין Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0) Cycophosphamide Conditioning regimen: 14.5 mg/kg intravenous 2 days on Day-6/Day-5 before graft (=Day0) Anti-Thymoglobulin Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0) הקרנה כלל גופית 2 grays on Day-1 before graft (=Day0) hematopoietic stem cells High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft) Graft nuclear cells Graft nuclear cells CD3+ cells if needed after transplantation Donor Lymphocytes Injection DLI with CD3+ if relapse after transplantation or in prevention of relapse Clofarabine Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0) |
משווה פעילTBF Conditioning regimen for LYMPHOID AND MYELOID HEMOPATHY | Methotrexate 15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0) Post-Transplant Cyclophosphamide 50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0) Anti-Thymoglobulin Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0) hematopoietic stem cells High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft) Graft nuclear cells Graft nuclear cells CD3+ cells if needed after transplantation Donor Lymphocytes Injection DLI with CD3+ if relapse after transplantation or in prevention of relapse Thiotepa Conditioning regimen: 5 mg/kg Intravenous at Day-6 before graft (=Day0) Busulfan Conditioning regimen: 3.2 mg/kg Intravenous 2 days at Day-2 and Day-1 before graft (=Day0) פלודרבין Conditioning regimen: 40 mg/m² intravenous 4 days on Day-5/Day-4/Day-3/Day-2 before graft (=Day0) |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Incidence of grade 3-4 acute GVHD following allo-CSH for all patients and for each conditioning group (Baltimore and TBF). | Estimation of the incidence of grade 3 and 4 acute GVHD following allo-CSH (excluding post-DLI\* acute GVHD) according to Mount Sinai criteria. | Post-transplant through study completion, an average of 1 year |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Incidence of engraftment | Engraftment assessed on hematological reconstitution (number of days of aplasia with PNN \<0.5 G/L and platelets \< 20 G/L, number of platelet and red cell concentrate transfusions) | Month 1 post-transplant |
Overall survival (OS) | survival between day 0 of transplantation and date of death or last follow-up | Post-transplant through study completion, an average of 1 year |
Disease-free survival (DFS) | survival between day 0 of transplantation and date of relapse, death or last follow-up | Post-transplant through study completion, an average of 1 year |
GVHD and relapse-free survival (GRFS) | relapse-free survival without grade 3-4 acute GVHD or chronic GVHD requiring systemic treatment | Post-transplant through study completion, an average of 1 year |
Incidence of acute GVHD grade 2-4 | Acute GVH grade 2-4 according to Mount Sinai criteria | Post-transplant through study completion, an average of 1 year |
Incidence of chronic GVHD | Chronic GVHD according to NCI criteria | From month 3 post-transplant through study completion, an average of 1 year |
Incidence of corticoresistant acute GVHD | Acute corticoresistant GVHD according to the criteria of Mohty et al. defined by :
* worsening/progression of disease after 3 days of 2mg/kg/day systemic corticosteroid therapy with methylprednisolone (or equivalent),
* non-improvement of disease after 7 days of 2mg/kg/day systemic corticosteroid therapy with methylprednisolone (or equivalent),
* disease progression to a new organ after treatment with 1mg/kg/day methylprednisolone (or equivalent) in the case of cutaneous or gastrointestinal GVHD or,
* recurrence of acute GVHD during or after the corticosteroid reduction phase | Post-transplant through study completion, an average of 1 year |
Incidence of non-relapse mortality (NRM) | any death unrelated to relapse or disease progression | Post-transplant through study completion, an average of 1 year |
Incidence of relapse | any documented disease recurrence | Post-transplant through study completion, an average of 1 year |
Chimerism | Total donor or mixed chimerism. Total donor chimerism = result \>95% donor CD3+ cells. Mixed chimerism = result \>5% and \<95% donor CD3+ cells. | At Month1, Month2, Month3, Month6, Month12 post-transplant |
Immune reconstitution | T, NK, B lymphocytes and monocytes | At Month3, Month6, Month9, Month12 post-transplant |
Grade 3 and 4 post-transplant adverse events | Grade 3 and 4 post-transplant adverse events (dates of occurrence) (NCI CTCAE criteria, version number 5) | Post-transplant through study completion, an average of 1 year |
Incidence of viral, bacteriological, fungal and parasitic infections | Infections: viral (CMV, EBV, BKV, adenovirus), bacteriological, fungal and parasitic | Post-transplant through study completion, an average of 1 year |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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 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
Nantes University Hospitalאיש קשר מרכזי למחקר
איש קשר: Amandine LE BOURGEOIS, MD, 02 40 08 32 71, [email protected]
3 מיקומי המחקר ב-1 מדינות