NCT06821542进行中（未招募）3 期
A Phase 3, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 254
- 主要终点
- Objective Response (OR) at 6 months
研究概览
简要总结
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years at the time of signing the ICF.
- •Active, moderate to severe cGVHD, requiring systemic immune suppression.
- •Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.
- •Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D
- •Topical and inhaled corticosteroid agents are allowed.
- •Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib.
- •History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
排除标准
- •Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- •Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
- •Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D
- •Severe renal impairment, that is, estimated creatinine clearance < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis.
- •Impaired liver function, defined as total bilirubin > 1.5 × ULN and/or ALT and AST > 3 × ULN in participants with no evidence of liver cGVHD.
- •History of acute or chronic pancreatitis.
- •Active, symptomatic myositis.
- •Pregnant or breastfeeding.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Axatilimab
Experimental
Axatilimab at the protocol-defined dose.
干预措施: INCA034176 (Drug)
Best available Treatment (BAT)
Experimental
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
干预措施: Best Available Therapy (BAT) (Drug)
结局指标
主要结局
Objective Response (OR) at 6 months
时间窗: 6 months
Defined for each treatment group as complete response (CR) or partial response (PR) at 6 months (Cycle 7 Day 1, 28-day cycles) in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.
次要结局
- Failure-free survival (FFS)(Up to 5 years)
- Proportion of participants with a ≥ 7-point improvement in modified Lee Symptom Scale (mLSS) total score(Up to 5 years)
- Overall Response at 12 months(12 months)
- Nonrelapse mortality (NRM)(Up to 5 years)
- Best Overall Response (BOR)(Up to 5 years)
- DOR (in responders only)(Up to 5 years)
- Organ-specific response(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Time to primary hematologic disease relapse(Up to 5 years)
- Percent reduction in daily corticosteroid dose at 6 months(6 months)
- Proportion of participants who tapered off all corticosteroids at 6 months(6 months)
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to 5 years and 30 days)
研究者
研究点 (254)
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