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临床试验 NCT06252870 (CY-MET-RIC) 针对移植物抗宿主病，血液恶性肿瘤目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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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) II期 82
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临床试验NCT06252870 (CY-MET-RIC)旨在研究治疗，主要针对移植物抗宿主病，血液恶性肿瘤。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2024年7月18日，计划招募82名患者。该研究由Nantes University Hospital主导，预计于2028年7月18日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月26日。
简要概括
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...
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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...
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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
疾病
移植物抗宿主病血液恶性肿瘤其他研究标识符
- CY-MET-RIC
- RC23_0286
NCT编号
实际开始日期
2024-07-18
最近更新发布
2026-01-26
预计完成日期
2028-07-18
计划入组人数
82
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
关键词
Hematopoietic stem cell allograft (Allo-CSH)
Methotrexate (MTX)
Post-transplant cyclophosphamide (PTCY)
Methotrexate (MTX)
Post-transplant cyclophosphamide (PTCY)
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性(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) 氟达拉滨 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) 全身照射 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) |
阳性对照TBF 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) 氟达拉滨 Conditioning regimen: 40 mg/m² intravenous 4 days on Day-5/Day-4/Day-3/Day-2 before graft (=Day0) |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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 Hospital研究中心联系人
联系人: Amandine LE BOURGEOIS, MD, 02 40 08 32 71, [email protected]
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