2023-505394-32-00暂停3 期
A randomized, double-blind, multicenter, Phase 3 study to evaluate efficacy and safety of belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids in participants at least 12 years of age with newly diagnosed chronic graft versus host disease (cGVHD)
Sanofi-Aventis Research & Development70 个研究点 分布在 8 个国家目标入组 154 人开始时间: 2024年2月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 154
- 试验地点
- 70
- 主要终点
- Event-Free Survival (EFS) from the date of randomization to the date of any predefined event, whichever occurs first
研究概览
简要总结
• Demonstrate the superiority of belumosudil in combination with prednisone vs placebo in combination with prednisone in Event-Free Survival (EFS)
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients must be at least 12 years of age inclusive, at the time of signing the informed consent
- •Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)
- •Participants who require systemic treatment with corticosteroids for cGVHD
- •Participants who have not received any prior systemic treatment for cGVHD (including ECP)
- •If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
- •Body weight ≥ 40kg
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Participants or their legally authorized representative must be capable of giving signed informed consent
排除标准
- •Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator’s judgement
- •Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer
- •Absolute neutrophil count (ANC) <0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
- •Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60
- •Platelets <25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
- •Any active, uncontrolled infections assessed to be clinically significant by the Investigator
- •Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years)
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN without liver cGVHD or>5 × ULN with liver) cGVHD
- •Total bilirubin >1.5 × (ULN) (>3 × ULN if Gilbert syndrome)
- •Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)
- •History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease)
- •Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
- •Known history of human immunodeficiency virus (HIV)
- •Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease after the most recent allogeneic HCT
- •Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
- •Unable to swallow tablets
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •Female participants who are pregnant or breastfeeding
- •Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day
- •Participant has had previous exposure to belumosudil.
- •Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant.
结局指标
主要结局
Event-Free Survival (EFS) from the date of randomization to the date of any predefined event, whichever occurs first
Event-Free Survival (EFS) from the date of randomization to the date of any predefined event, whichever occurs first
次要结局
- Proportion of participants who achieve a clinically relevant reduction in mLSS of at least 6 points from baseline (Only in participants at least 18 years of age)
- Proportion of participants who achieve an overall response (PR or CR) as per 2014 NIH consensus response criteria by 48 weeks and maintained the response for a duration of at least 6 months
- Proportion of participants who successfully discontinue all systemic corticosteroids for cGVHD for at least 30 days before the occurrence of cGVHD progression, or start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or unacceptable toxicity
- Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD
- Time from the date of the first response to the date of cGVHD progression, start of new systemic treatment for cGVHD, or death, whichever occurs first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH consensus response criteria
- Proportion of participants with a reduction in daily corticosteroid dose
- Failure Free Survival (FFS) is defined as the time from the date of randomization to the date of start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first.
- Change from baseline in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) (Only in participants at least 18 years of age) and the European Quality of Life Group Questionnaire with 5 Dimensions and 5 Levels (EQ5D5L)
- Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)
- The time from the date of randomization to the date of death due to any cause
- Time to Response is defined as the time from randomization to the date the patient has first response (CR or PR).
- Proportion of participants who achieve CR or PR as per NIH consensus response criteria (2014) at any time point in each involved organ and before the start of a new systemic therapy for cGVHD.
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Research & Development
研究点 (70)
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