2024-519986-23-00招募中3 期
Reduced post-transplant cyclophosphamide dose in patients undergoing haploidentical hematopoietic stem cell transplantation for hematological malignancies: a phase III randomized study (REDUCy)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 15
- 主要终点
- assessment of the GREFS at 2 years after HSCT, a composite endpoint defined as the probability of survival without severe GVHD, relapse/progression of the hematological malignancy, or PTCy-associated adverse event, whichever comes first from transplantation
研究概览
简要总结
The primary objective is to evaluate the efficacy of reducing the total dose of PTCy to 70 mg/kg on GREFS compared to the standard dose of 100 mg/kg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.
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
- 否
入选标准
- •Age ≥ 18 years
- •Confirmed hematological malignancy with an indication for allogeneic HSCT
- •Presence of a haploidentical donor willing to donate PBSC
- •Patient planned to receive a thiotepa-based conditioning regimen
- •Provision of written informed consent
- •Affiliation to a social security system (excluding “Aide Médicale d’État”)
排除标准
- •Karnofsky performance status < 70%
- •Concurrent participation in another investigational therapeutic study
- •Inability to comply with study procedures
- •Life expectancy < 1 month, as determined by the attending physician
- •Acute or chronic heart failure, defined as left ventricular ejection fraction < 40%
- •Pulmonary dysfunction with diffusion capacity < 50% of predicted values
- •Renal impairment with estimated glomerular filtration rate (eGFR) < 45 mL/min (calculated using the CKD-EPI formula)
- •Positive HIV status
- •Pregnancy, breast-feeding, or refusal to use effective contraception
- •Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)
- •Hypersensitivity to the active substance or any of the excipients
结局指标
主要结局
assessment of the GREFS at 2 years after HSCT, a composite endpoint defined as the probability of survival without severe GVHD, relapse/progression of the hematological malignancy, or PTCy-associated adverse event, whichever comes first from transplantation
assessment of the GREFS at 2 years after HSCT, a composite endpoint defined as the probability of survival without severe GVHD, relapse/progression of the hematological malignancy, or PTCy-associated adverse event, whichever comes first from transplantation
次要结局
- Overall survival (OS) at 2 years: From transplantation until death from any cause or up to 24 months, whichever occurs first
- Quality of life at 1, 3, 6, 12, and 24 months after HSCT compared to baseline using two questionnaires: FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant, version 4) and EQ-5D-5L (EuroQol 5-Dimension, 5-Level questionnaire).
- Organ damage toxicities assessed by the common terminology criteria for adverse events (CTCAE) v5.0, cumulative incidences of bacterial, viral, and fungal infections, and failure to achieve neutrophil recovery (absolute neutrophil count > 0.5 x 109/L) or platelet recovery (platelet count > 50 x 109/L) after HSCT From transplantation until the occurrence of the event, day +60 for hematological recovery, or up to 24 months for organ damage toxicities and infections, whichever occurs first
- Cumulative incidence and severity of acute and chronic GVHD: From transplantation until the occurrence of GVHD or death from any cause, or up to 180 days after transplantation for acute GVHD, or up to 24 months for chronic GVHD, whichever occurs first
- Non-relapse mortality (NRM) at 2 years: From transplantation until death without evidence of relapse or up to 24 months, whichever occurs first
- Cumulative incidence of relapse at 2 years: From transplantation until the occurrence of relapse or up to 24 months, whichever occurs first
- Disease-free survival (DFS) at 2 years: From transplantation until relapse or progression of the hematological disease, death, or up to 24 months, whichever occurs first
- GVHD-free, relapse-free survival (GRFS) at 2 years: From transplantation until the occurrence of acute grade III-IV GVHD, severe chronic GVHD, relapse, death, or up to 24 months, whichever occurs first
- Incremental cost-effectiveness (cost/life year) and cost-utility (cost/quality-adjusted life-year, QALY) ratios at 2 years.
研究者
Scientific Director
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
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