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阿西米尼作为费城染色体阳性急性淋巴细胞白血病的成年人的细胞疗法后的维持治疗

2026年10月30日 更新者：City of Hope Medical Center

费城染色体阳性急性淋巴细胞性白血病的成年人的细胞疗法的Asciminib作为维持治疗的试点研究

This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
招聘中

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

PRIMARY OBJECTIVES:

I. Evaluate the safety of asciminib maintenance in adults with Philadelphia chromosome (Ph)+ acute lymphoblastic leukemia (ALL) in morphological complete remission (CR) post hematopoietic stem cell transplantation (HSCT; Arm 1) or chimeric antigen receptor (CAR) T cell therapy (Arm 2).

II. Determine the recommended phase 2 dosing (RP2D) of asciminib maintenance post cellular therapies in Ph+ ALL in each arm.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of asciminib maintenance measured as the number of patients who continue asciminib > 3 cycles post cellular therapy.

II. Duration of response. III. Timing for minimal residual disease (MRD) and full relapse. IV. Relapse free survival at 1 year post cellular therapy. V. Overall survival at 1 year post cellular therapy. VI. Non-relapse mortality at 1 year post cellular therapy. VII. Relapse at 1 year post cellular therapy. VIII. Rates of asciminib discontinuation and interruption due to toxicity at 1 year post cellular therapy.

IX. Rate of switching to another tyrosine kinase inhibitor (TKI) at 1 year post cellular therapy X. Rate and grade of acute graft-versus-host disease (GVHD) at 180 days post initiation of asciminib maintenance post HSCT. (Arm 1) XI. Rate and grade of chronic GVHD at 1 year post initiation of asciminib maintenance post HSCT. (Arm 1) XII. GVHD-free, relapse-free survival (GRFS) at 1 year post HSCT. (Arm 1)

EXPLORATORY OBJECTIVES:

I. For patients who are MRD-negative, evaluate MRD relapse by clonoSEQ during therapy.

II. Evaluate immune cell populations and immune reconstitution post-transplant during asciminib therapy.

III. Evaluate the impact of prevalent BCR-ABL mutations and treatment emergent BCR-ABL mutations.

IV. Evaluate B-cell aplasia and CAR T cell persistence during asciminib therapy. (Arm 2) V. Quality of life assessments using Patient Reported Outcomes Measurement Information System (PROMIS).

OUTLINE: This is a dose-escalation study of asciminib followed by a dose-expansion study.

Patients receive asciminib orally (PO) once daily (QD) or twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening and as clinically indicated, and bone marrow biopsy, bone marrow aspirate and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days then every 3 months for 1 year.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
30

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope Medical center
        • 首席研究员：
          • Ibrahim Aldoss
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • PRE-SCREENING: Documented informed consent of the participant and/or legally authorized representative

  • PRE-SCREENING: Age ≥ 18 years

  • PRE-SCREENING: Participant was diagnosed with Ph+ ALL according to World Health Organization criteria. The BCR::ABL1 translocation may be detected by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next generation sequencing (NGS), or cytogenetics at least once any time prior to cellular therapy. Participants may have p190 or p220 isoform, and participants with T315I mutation are not excluded

  • PRE-SCREENING: Participant meets one of the following criteria:

    • Arm 1: Have a date for HSCT scheduled within the next 30 days or have received HSCT within the last 30 days. Note: all HSCT donors, conditioning regimens, and GVHD prophylaxis regimens will be acceptable.
    • Arm 2: Have a date for CAR T cell infusion scheduled within the next 30 days or have received CAR T cell infusion within the last 30 days

  • PRE-SCREENING: History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

  • PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Documented informed consent of the participant and/or legally authorized representative.

    • Assent, when appropriate, will be obtained per institutional guidelines

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Eastern Cooperative Oncology Group (ECOG) ≤ 2

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant is between day +30 and +150 after one of the following cellular therapies:

    • Arm 1: HSCT

      • Participants on Arm 1 must be fully engrafted post-HSCT.

    • Arm 2: CD19-targeted CAR T cell therapy (brexucabtagene autoleucel, tisagenlecleucel, obecabtagene autoleucel, investigational CD19 CAR T cell therapy)

      • Participants on Arm 2 must be fully recovered from cytopenia

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Day 30 (+/- 5 days) marrow post cellular therapy should show evidence of complete morphologic remission defined as < 5% bone marrow (BM) blasts, no extramedullary disease, and transfusion independence

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant should have no morphological evidence of relapse

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Absolute neutrophil count (ANC) ≥ 500/mm^3 for 3 days

    • NOTE: Patients are allowed growth factors

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Platelets ≥ 75,000/mm^3

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Hemoglobin ≥ 9g/dL

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Aspartate aminotransferase (AST) ≤ 3.0 x ULN

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Alanine aminotransferase (ALT) ≤ 3.0 x ULN

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: serum creatinine <1.5 mg/dL

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Left ventricular ejection fraction (LVEF) ≥ 50%

    • Note: To be performed within 28 days prior to day 1 of protocol therapy

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Bazett's corrected QT interval (QTcB) ≤ 480 ms

    • Note: To be performed within 28 days prior to day 1 of protocol therapy

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Oxygen (O2) saturation > 90% on room air

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Seronegative for HIV antigen (Ag)/antibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR

    • If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Meets other institutional and federal requirements for infectious disease titer requirements

    • Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

  • PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.

    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Exclusion Criteria:

  • Prior treatment failure with asciminib

  • Treatment with strong inducers of CYP3A is not allowed and should be switched to an alternative at least 1 week prior to the start of study treatment

  • ARM 1: Treatment with prior HSCT is allowed

  • ARM 2: Treatment with prior CAR T cell therapy is allowed

  • Cardiac or cardiac repolarization abnormality, including any of the following:

    • History within 6 months prior to starting study treatment of myocardial infarction (MI), or coronary artery bypass graft (CABG)
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
    • Fridericia's corrected QT interval (QTcF) at screening ≥ 450 msec (male patients), ≥ 470 msec (female patients)
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome

  • History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

  • ARM 1: Active grade 3 or higher graft-versus-host disease (GVHD) after allogeneic HSCT within 14 days of enrollment. Note: prednisone administration (flat dose of 0.5 mg/kg) is allowed. Patients receiving any other medication to control active/progressive GVHD will be excluded

  • Clinically significant uncontrolled illness

  • Active infection not responding to treatment

  • Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Females only: Pregnant or breastfeeding

  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Treatment (Asciminib)

Patients receive asciminib PO QD or BID on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening and as clinically indicated, and bone marrow biopsy, bone marrow aspirate and blood sample collection throughout the study.
程序：Bone Marrow Biopsy

Undergo bone marrow biopsy

其他名称：
  • 骨髓活检
  • 活组织检查，骨髓
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
程序：Bone Marrow Aspiration

Undergo bone marrow aspiration

程序：Echocardiography Test

Undergo echocardiography

其他名称：
  • 超声心动图
  • 欧共体
其他：Survey Administration

Ancillary studies

药品：Asciminib

Given PO

其他名称：
  • ABL001
  • ABL-001
  • ABL 001

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Incidence of adverse events
大体时间：From start of treatment on day 1 to the end of cycle 1 on day 28

Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The toxicity/adverse event information recorded on each subject will include type, severity, duration, attribution/ association with the study agent by arm and cycle. Tables will be constructed to summarize the observed incidence, severity and type of toxicity, including infection. Point estimates and 90% confidence intervals will be provided.
From start of treatment on day 1 to the end of cycle 1 on day 28

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Number of patients who have completed at least 3 cycles of asciminib and have taken ≥ 70% planned doses in each cycle post cellular therapy
大体时间：Up to completion of 3 cycles (cycle length= 28 days)

The protocol therapy will be deemed feasible if > 70% or higher of patients meet this feasibility criteria. Point estimates and 90% confidence intervals will be provided.
Up to completion of 3 cycles (cycle length= 28 days)
Duration of remission
大体时间：Up to 1 year after completion of study treatment

Point estimates and 90% confidence intervals will be provided.
Up to 1 year after completion of study treatment
Relapse including minimal residual disease (MRD) relapsed
大体时间：Up to 1 year after completion of study treatment

MRD relapse assed by polymerase chain reaction (PCR) and flow cytometry. MRD relapse is defined as detectable leukemic cells at > 0.01% in morphological remission bone marrow. However, due to rate of false positivity of PCR BCR::ABL1, confirmation is required by either positive MRD flow or/and clonoSEQ > 0.01%. Will be calculated using the competing risk method. Point estimates and 90% confidence intervals will be provided.
Up to 1 year after completion of study treatment
Relapse free survival
大体时间：From start of protocol therapy to relapse, or death, up to 1 year after completion of study treatment

Kaplan-Meier curves will be used for survival endpoints. Point estimates and 90% confidence intervals will be provided.
From start of protocol therapy to relapse, or death, up to 1 year after completion of study treatment
Overall survival
大体时间：From start of protocol therapy to death regardless of cause, up to 1 year after completion of study treatment

Kaplan-Meier curves will be used for survival endpoints. Point estimates and 90% confidence intervals will be provided.
From start of protocol therapy to death regardless of cause, up to 1 year after completion of study treatment
Non-relapse mortality
大体时间：From start of protocol therapy to death without relapse/progression, up to 1 year after completion of study treatment

Will be calculated using the competing risk method. Point estimates and 90% confidence intervals will be provided.
From start of protocol therapy to death without relapse/progression, up to 1 year after completion of study treatment
Switching tyrosine kinase inhibitors (TKI)
大体时间：Up to 1 year after completion of study treatment

Defined as changing treatment to a different TKI due to asciminib toxicity or intolerability per the treating physician judgment. Point estimates and 90% confidence intervals will be provided.
Up to 1 year after completion of study treatment
Asciminib discontinuation
大体时间：Up to 1 year

Discontinuation is defined as not taking asciminib > 28 days due to treatment-related toxicity. Point estimates and 90% confidence intervals will be provided.
Up to 1 year
Asciminib interruption
大体时间：Up to 1 year

Interruption is defined as not taking asciminib for > 7 days because of treatment-related toxicity. Point estimates and 90% confidence intervals will be provided.
Up to 1 year
Rate of acute graft versus host disease (aGVHD) of grades 2-4 (arm 1)
大体时间：From hematopoietic stem cell transplantation (HSCT) to day 180 post HSCT

Documented/biopsy proven aGVHD is graded according to Mount Sinai Acute graft versus host disease (GVHD) International Consortium (MAGIC) grading. Point estimates and 90% confidence intervals will be provided.
From hematopoietic stem cell transplantation (HSCT) to day 180 post HSCT
Rate of aGVHD of grades 3-4 (Arm 1)
大体时间：From HSCT to day 180 post HSCT

Documented/biopsy proven aGVHD is graded according to MAGIC Grading. Point estimates and 90% confidence intervals will be provided.
From HSCT to day 180 post HSCT
GVHD-free, relapse-free survival (Arm 1)
大体时间：From start of protocol therapy to the first observation of developing grade 3-4 aGVHD, chronic (c) GVHD requiring systemic therapy, relapse/progression, or death, whichever comes first, up to 1 year after completion of study treatment

Kaplan-Meier curves will be used for survival endpoints. Point estimates and 90% confidence intervals will be provided.
From start of protocol therapy to the first observation of developing grade 3-4 aGVHD, chronic (c) GVHD requiring systemic therapy, relapse/progression, or death, whichever comes first, up to 1 year after completion of study treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
City of Hope Medical Center

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
National Cancer Institute (NCI)

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Ibrahim Aldoss、City of Hope Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2025年12月17日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2029年6月9日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2029年6月9日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2025年6月18日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2025年6月18日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2025年6月27日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月3日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年10月30日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • 25023
  • P30CA033572 (美国 NIH 拨款/合同)
  • 25023 (其他标识符：City of Hope Medical center)
  • NCI-2025-04103 (注册表标识符：CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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