2024-518568-11-00招募中2 期
Allogeneic hematopoietic cell transplantation from HLA-matched donor after Flu-Mel-PTCy versus Flu-Mel-ATG reduced-intensity conditioning: a phase II randomized study from the Belgian Hematology Society (BHS)
Centre Hospitalier Universitaire De Liege, Centre Hospitalier Universitaire De Liege9 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年10月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 9
- 主要终点
- To assess the current GVHD-free, relapse-free survival (cGRFS) for patients conditioned with FM-PTCy or FM-ATG
研究概览
简要总结
The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Disease: Hematological malignancies confirmed histologically: - AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count < 10 000 x109/mL); - MDS; - CML in CP or AP; - MPD not in blast crisis, - MDS/MPD overlap, - ALL in CR; - Multiple myeloma; BHS-TC 14- Protocol Version 3.0 of 13JUNE2022 Page 10 / 32 - CLL; - Non-Hodgkin’s lymphoma (aggressive NHL should have chemosensitive disease); - Hodgkin’s disease with chemosensitive disease or responding to checkpoint inhibitors.
- •Clinical situations: • Theoretical indication for a standard allo-transplant, but not feasible because: - Age > 50 yrs; - Unacceptable end organ performance; - The physician’s decision; - The patient’s decision • Underlying ‘lower risk’ disease, for which RIC is preferred (eg CLL, MCL) • Continuation of maintenance with TKI are allowed after allo-HCT in case of Ph+ leukemia or FLT-3 mutated AML. Administration of other maintenance (defined as administration without evidence of relapse/progression of the underlying disease) treatments are not allowed in the protocol.
- •Other inclusion criteria: • Male or female; fertile patients must use a reliable contraception method; • Age 18-75 yrs (children of any age are not allowed in the protocol); • Informed consent given by patient or his/her guardian if indicated.
排除标准
- •Exclusion criteria: • Any condition not fulfilling inclusion criteria; • HIV positive; • Non-hematological malignancy(ies) (except non-melanoma skin cancer) active < 3 years before HCT. • Life expectancy severely limited by disease other than malignancy; • CNS involvement with disease refractory to intrathecal chemotherapy. • Terminal organ failure, except for renal failure (dialysis acceptable) a. Cardiac: Symptomatic coronary artery disease; ejection fraction <40%; uncontrolled arrhythmia, uncontrolled hypertension; b. Pulmonary: DLCO < 40% and/or receiving supplementary continuous oxygen, FEV1< 40%; c. Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease; • Uncontrolled infection; • Karnofsky Performance Score <70%; • Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment; • Patient is a female who is pregnant or breastfeeding; • Any condition precluding the use of melphalan or ATG
结局指标
主要结局
To assess the current GVHD-free, relapse-free survival (cGRFS) for patients conditioned with FM-PTCy or FM-ATG
To assess the current GVHD-free, relapse-free survival (cGRFS) for patients conditioned with FM-PTCy or FM-ATG
次要结局
- 1. To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor.
- 2. To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG.
- 3. To assess the rates of grade II-IV and III-IV acute (at 6 months) and moderate/severe cGVHD (at 24 months) in patients conditioned with FM-PTCy or FM-ATG.
- 4. To assess the rates of NRM as well as LFS and OS in patients conditioned with FM-PTCy or FM-ATG.
- 5. To assess the proportion of patients alive without active disease and without systemic immunosuppression 1, 2, 3, 4, 5, 7, 10 and 15-years after transplantation in patients conditioned with FM-PTCy or FM-ATG.
研究者
Josephine Muller
Scientific
Centre Hospitalier Universitaire De Liege
研究点 (9)
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