2024-514517-35-00招募中3 期
IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.32 个研究点 分布在 7 个国家目标入组 361 人开始时间: 2024年11月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 361
- 试验地点
- 32
- 主要终点
- Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first
研究概览
简要总结
To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy
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
- •Non-APL AML defined according WHO 2022 (or ICC 2022) criteria
- •1st or 2nd relapse or refractory according to ELN 2022
- •Patient is clinically candidate both to low intensity therapy and to high dose chemotherapy in the opinion of the physician
- •Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
- •No specific treatment protocol can be rationally considered better suited to patient needs. This specifically include, but is not limited to i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
- •Male or Female, aged>18 years
- •ECOG performance status <4
- •A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
- •Participant is willing and able to give informed consent for participation in the study
排除标准
- •Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of SmPC (e.g. hypersensitivity, allergy, organ failure precluding treatment)
- •Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization.
- •Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
结局指标
主要结局
Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first
Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first
次要结局
- Overall survival, defined as time from randomization to the date of death from any cause
- Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort
- Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.
- Proportion of patients experiencing adverse events
研究者
Oriana Nanni
Scientific
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
研究点 (32)
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