Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial (Ph- ALL-2026)
2026年6月8日 更新者：Institute of Hematology & Blood Diseases Hospital, China
A Prospective Umbrella Clinical Trial of Immuno-Targeted Agents Combined With Low-Dose Chemotherapy for Newly Diagnosed Adult Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.
The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
32
阶段
- 阶段2
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。
学习联系方式
- 姓名：Ying Wang, MD, PhD
- 电话号码：+86 22-23608095
- 邮箱：wangying1@ihcams.ac.cn
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
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.
- CD22-positive expression on tumor cells (CD22 ≥20%).
- Expected survival ≥3 months.
- Sexually active men and women of childbearing potential must agree to use effective contraception.
- Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures.
Exclusion Criteria:
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnant women.
- Severe, uncontrolled active infections.
- History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS).
- History of clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), or sinus node dysfunction or high-grade atrioventricular (AV) block with chronic bradycardia, unless a permanent pacemaker has been implanted.
- Uncontrolled active hepatitis B or hepatitis C infection, or known HIV seropositivity. HIV testing may be required according to local regulations or standards.
- Psychiatric disorders that may impair the subject's ability to complete treatment or provide informed consent.
- Any other conditions deemed by the investigator to render the subject unsuitable for participation in the study.
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：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immuno-Targeted Therapy Plus Low-Dose Chemotherapy
Adult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL) receive frontline treatment with immuno-targeted agents, a BCL2 inhibitor, and low-dose chemotherapy.
Induction therapy includes inotuzumab ozogamicin, venetoclax, vincristine, cyclophosphamide, and dexamethasone.
Subsequent treatment is adapted according to measurable residual disease (MRD) response, antigen expression profile, and clinical condition, and may include blinatumomab-based immunotherapy, venetoclax-containing chemotherapy, CD19-directed CAR-T cell therapy, or hematopoietic stem cell transplantation.
All patients proceed to protocol-defined maintenance therapy.
|
Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.
Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.
A vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells.
An alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells.
A synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden.
A folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells.
A pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation.
A glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy.
A purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Flow Cytometric MRD-Negative Complete Remission Rate
大体时间：At the end of induction therapy (approximately 1 month after treatment initiation)
|
Proportion of patients achieving complete remission (CR) with negative measurable residual disease (MRD) assessed by multiparameter flow cytometry after completion of induction therapy.
|
At the end of induction therapy (approximately 1 month after treatment initiation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Next-Generation Sequencing (NGS)-MRD Negative Remission Rate
大体时间：Within 3 months after treatment initiation
|
Proportion of patients achieving MRD-negative remission assessed by immune repertoire sequencing.
|
Within 3 months after treatment initiation
|
|
Best MRD Clearance Rate
大体时间：Within 3 months after treatment initiation
|
Proportion of patients achieving the deepest MRD response during the first 3 months of treatment as assessed by flow cytometry, quantitative PCR, or immune repertoire sequencing.
|
Within 3 months after treatment initiation
|
|
Overall Survival (OS)
大体时间：Up to 5 years
|
Time from study enrollment to death from any cause.
|
Up to 5 years
|
|
Disease-Free Survival (DFS)
大体时间：Up to 5 years
|
Time from achievement of complete remission to relapse or death from any cause.
|
Up to 5 years
|
|
Relapse-Free Survival (RFS)
大体时间：Up to 5 years
|
Time from achievement of MRD-negative remission to hematologic relapse or death.
|
Up to 5 years
|
|
30-Day Mortality
大体时间：30 days
|
Proportion of patients who die from any cause within 30 days after treatment initiation.
|
30 days
|
|
60-Day Mortality
大体时间：60 days
|
Proportion of patients who die from any cause within 60 days after treatment initiation.
|
60 days
|
|
Incidence of Adverse Events
大体时间：From treatment initiation through completion of study treatment, up to 5 years
|
Frequency, severity, and type of adverse events graded according to the National Cancer
|
From treatment initiation through completion of study treatment, up to 5 years
|
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。
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 (估计的)
2026年6月12日
初级完成 (估计的)
2028年5月31日
研究完成 (估计的)
2030年5月31日
研究注册日期
首次提交
2026年6月8日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 氨基酸，肽和蛋白质
- 蛋白质
- 硫化合物
- 有机化学品
- 杂环化合物，1形
- 杂环化合物
- 杂环化合物，2环
- 杂环化合物，融合环
- 核酸，核苷酸和核苷
- 碳氢化合物
- 碳水化合物
- 生物碱
- 多环化合物
- 糖苷
- 吲哚
- 抗体，单克隆，人源化
- 抗体，单克隆
- 抗体
- 免疫球蛋白
- 免疫蛋白
- 血蛋白
- 血清球蛋白
- 球蛋白
- 嘌呤
- 胞苷
- 嘧啶核苷
- 嘧啶
- 怀孕
- 怀孕
- 类固醇
- 融合环化合物
- 类固醇，氟化
- 磷酰胺芥末
- 氮芥末化合物
- 芥末化合物
- 碳氢化合物，卤素
- 磷酰胺
- 有机磷化合物
- 核苷
- 翼
- 翼状
- 疗法
- 妊娠二培养子
- VINCA生物碱
- Secologanin色素生物碱
- 吲哚生物碱
- 吲哚衍生物
- 吲哚王
- 阿拉伯核苷
- 氨基翅目
- 氨基糖苷
- 亚硫烯基化合物
- Calicheamicins
- 伊珠单抗奥佐米星
- 地塞米松
- 甲氨蝶呤
- 强的松
- 环磷酰胺
- 阿糖胞苷
- 长春新碱
- 巯基嘌呤
- Venetoclax
- blinatumomab
其他研究编号
- IIT2026063
- IIT2026063-EC-1 (其他标识符：Ethics Committee of Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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