jRCT2031260265尚未招募不适用
Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Patients With Ph+ CML-CP (CABL001I12202)
未提供0 个研究点目标入组 3 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 1age old over 至 18age old not（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Male or female participants 1 and < 18 years of age at study enrollment
- •Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome
- •For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:
- •Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:
- •At three months after the initiation of therapy: BCR::ABL1 ratio > 10% IS (if confirmed within 1-3 months)
- •At six months after the initiation of therapy: BCR::ABL1 ratio > 10% IS
- •At twelve months after initiation of therapy: BCR::ABL1 ratio > 1% IS
- •At any time loss of previous response
- •At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results
- •Intolerance to TKI is defined as:
- •Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)
- •Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count [ANC] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI
- •Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] at the time of screening which are amenable to standardized RQ-PCR quantification.
- •Performance status: Karnofsky >= 50% for participants >= 16 years of age, and Lansky >= 50 for participants < 16 years of age at the time of screening.
排除标准
- •Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)/Blast Phase (BP).
- •Previous treatment with a hematopoietic stem-cell transplantation.
- •Patient planned to undergo allogeneic hematopoietic stem cell transplantation
- •Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry
研究者
相似试验
招募中
1 期
A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.Advanced solid tumors, specifically:
• metastatic clear cell renal carcinoma
• proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF-V600E-mutant negative colorectal carcinoma
• locally advanced or metastatic pancreatic adenocarcinoma2025-522243-17-00Philogen S.p.A.96
已完成
2 期
A study to investigate safety and efficacy with SAR445514 in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light-chain amyloidosis (RRLCA)Relapsed/refractory multiple myelomaAmyloid light-chain amyloidosis2022-502057-33-00Sanofi-Aventis Recherche & Developpement59
招募中
1 期
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants with Advanced Solid MalignanciesParticipants with Advanced Solid Malignancies2024-511453-22-00Kumquat Biosciences Inc.112
招募中
不适用
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (J2A-MC-GZPR)Peripheral Arterial DiseasejRCT20312505701,205
招募中
1 期
A study to determine the safety and effect of antibodies against hepatitis D (the SAMBA-D study)Chronic hepatitis D infection2025-522125-36-00Region Midtjylland15