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A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) (REVIVAL)

2026年9月11日 更新者：AbbVie

A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy.

Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide.

In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

660

阶段

  • 阶段2
  • 第三阶段

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

学习地点

  • 以色列
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus- Haifa /ID# 278719
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Medical Center /ID# 278712
      • Jerusalem、以色列、91120
        • 招聘中
        • Hadassah Medical Center-Hebrew University /ID# 278866
    • Central District
      • Petah Tikva、Central District、以色列、4941492
        • 招聘中
        • Rabin Medical Center /ID# 278714
    • Tel Aviv
      • Tel Aviv、Tel Aviv、以色列、6423906
        • 招聘中
        • Tel Aviv Sourasky Medical Center /ID# 278717
  • 台湾
      • Taichung、台湾、40447
        • 招聘中
        • China Medical University Hospital /ID# 279261
      • Taichung、台湾、407
        • 招聘中
        • Taichung Veterans General Hospital /ID# 279296
      • Taipei、台湾、100
        • 招聘中
        • National Taiwan University Hospital /ID# 279289
      • Taoyuan City、台湾、333
        • 招聘中
        • Linkou Chang Gung Memorial Hospital /ID# 279294
  • 奥地利
      • Vienna、奥地利、1090
        • 招聘中
        • Medizinische Universitaet Wien /ID# 278825
    • Lower Austria
      • Sankt Pölten、Lower Austria、奥地利、3100
        • 招聘中
        • Universitaetsklinikum St. Poelten /ID# 278835
    • State of Vienna
      • Vienna、State of Vienna、奥地利、1140
        • 招聘中
        • Hanusch-Krankenhaus /ID# 279467
    • Styria
      • Graz、Styria、奥地利、8010
        • 招聘中
        • Medizinische Universitaet Graz /ID# 278830
    • Upper Austria
      • Linz、Upper Austria、奥地利、4010
        • 招聘中
        • Ordensklinikum Linz Elisabethinen /ID# 278824
  • 法国
    • New Aquitaine
      • Pessac、New Aquitaine、法国、33604
        • 招聘中
        • Centre Hospitalier Universitaire de Bordeaux /ID# 279001
    • Pays de la Loire Region
      • Angers、Pays de la Loire Region、法国、49933
        • 招聘中
        • Centre Hospitalier Universitaire D'Angers /ID# 280390
  • 美国
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope National Medical Center /ID# 279568
    • Florida
      • Tampa、Florida、美国、33612
        • 招聘中
        • Moffitt Cancer Center /ID# 279192
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Winship Cancer Institute of Emory University /ID# 279006
    • New York
      • The Bronx、New York、美国、10467
        • 招聘中
        • Montefiore Medical Center - Moses Campus /ID# 279399
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • The University of Texas MD Anderson Cancer Center /ID# 279402
  • 西班牙
    • Madrid
      • Majadahonda、Madrid、西班牙、28222
        • 招聘中
        • Hospital Universitario Puerta De Hierro /ID# 279660
    • Navarre
      • Pamplona、Navarre、西班牙、31008
        • 招聘中
        • Clinica Universidad de Navarra - Pamplona /ID# 279516
  • 韩国
    • Gyeonggido
      • Seongnam-si、Gyeonggido、韩国、13620
        • 招聘中
        • Seoul National University Bundang Hospital /ID# 279634
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韩国、06351
        • 招聘中
        • Samsung Medical Center /ID# 279397
      • Seoul、Seoul Teugbyeolsi、韩国、05505
        • 招聘中
        • Asan Medical Center /ID# 279395
      • Seoul、Seoul Teugbyeolsi、韩国、03722
        • 招聘中
        • Yonsei University Health System Severance Hospital /ID# 279933
      • Seoul、Seoul Teugbyeolsi、韩国、03080
        • 招聘中
        • Seoul National University Hospital /ID# 279396

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:

  1. Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria with a projected life expectancy of at least 12 weeks.
  2. CD123-positive

  3. Ineligible for intensive induction therapy (chemotherapy) defined by:

    • ≥ 75 years of age OR

    • ≥ 18 to 74 years of age with at least one of the following co-morbidities:

      • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
      • Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina
      • Diffusion capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%
      • Creatinine clearance ≥ 30 mL/min to < 45 mL/min
      • Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × upper limit of normal (ULN)
      • Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the medical monitor before study enrollment.
  4. ECOG performance status 0 to 2 for subjects ≥ 75 years of age or 0 to 3 for subjects ≥ 18 to 74 years of age.
  5. White blood cell (WBC) count < 25 × 10^9/L (hydroxyurea is permitted prior to beginning study treatment to reduce the WBC count to < 25 × 10^9/L).

  6. Subjects must have adequate organ function:

    • Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.

    • Adequate liver function as demonstrated by:

      • Aspartate aminotransferase (AST) ≤ 3.0 × ULN*,

      • Alanine aminotransferase (ALT) ≤ 3.0 × ULN*,

        ---*Unless considered due to leukemic organ involvement

      • Subjects < 75 years of age may have total bilirubin ≤ 3 x ULN
      • Subjects ≥ 75 years of age total bilirubin ≤ 1.5 × ULN unless elevated level is considered to be due to Gilbert's syndrome or hemolysis, total bilirubin must be < 3 x ULN and direct bilirubin < 1 x ULN
      • Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × ULN International Normalized Ratio (INR) <1.5

Exclusion Criteria:

  • Acute promyelocytic leukemia (APL), blast phase of CML or AML with t(9;22) or BCR:ABL1 fusion, transformation from myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), myelodysplastic/myeloproliferative neoplasm unspecified, or myeloid sarcoma.
  • Known active central nervous system (CNS) involvement with AML. Participants may have non-CNS extramedullary disease (excludes participants with myeloid sarcoma as the only disease manifestation at screening).
  • Participants with history of any malignancies within 2 years prior to screening with exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast, in situ - carcinomas of bladder and esophagus; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have no evidence of relapse within 2 years.
  • Participants must not have received a hypomethylating agent, any BCL-2 inhibitors including venetoclax, and/or chemotherapeutic agent for Myelodysplastic syndromes (MDS) or AML, CAR-T cell therapy, be currently participating in another clinical study, received any investigational treatment within 30 days prior to the first use of study combination product.
  • Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study and for approximately 7 months after the last dose of any study drug. Female participant of childbearing potential must agree to use at least 1 protocol specified method of birth control and male participant, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.

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：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Phase 2: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
药品：匹维基单抗 苏尼林
静脉注射
药品：Venetoclax
Orally
药品：Azacitidine
Intravenous Or Subcutaneous
有源比较器：Phase 2: Arm B - VEN and AZA
Participants will receive VEN and AZA
药品：Venetoclax
Orally
药品：Azacitidine
Intravenous Or Subcutaneous
实验性的：Phase 3: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
药品：匹维基单抗 苏尼林
静脉注射
药品：Venetoclax
Orally
药品：Azacitidine
Intravenous Or Subcutaneous
实验性的：Phase 3: Arm B - PVEK-Placebo, VEN, and AZA
Participants will receive PVEK-Placebo, VEN, and AZA
药品：Venetoclax
Orally
药品：Azacitidine
Intravenous Or Subcutaneous
药品：Matching Placebo for PVEK
Intravenous

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
Phase 2: Complete remission (CR)
大体时间：Up to Approximately 71 Months
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
Up to Approximately 71 Months
Phase 3: Complete remission (CR)
大体时间：Up to Approximately 71 Months
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
Up to Approximately 71 Months
Phase 3: Overall Survival (OS)
大体时间：Up to Approximately 71 Months
The time (in number of days) from randomization to death due to any cause.
Up to Approximately 71 Months
Number of Participants with Adverse Events (AEs)
大体时间：Up to approximately 71 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 71 months

次要结果测量

结果测量
措施说明
大体时间
Phase 2 and Phase 3: Composite Response
大体时间：Up to Approximately 71 Months
Composite Complete Remission (CR) + Complete Remission with Incomplete Blood Count Recovery (CRi) and Complete Remission (CR) + Complete Remission with Partial Hematologic Recovery (CRh) response defined as participants achieving CR plus CRi, and CR plus CRh
Up to Approximately 71 Months
Phase 2 and Phase 3: Duration of CR (DoCR)
大体时间：Up to Approximately 71 Months
Duration of CR (DoCR) defined as the time from achieving CR to hematologic relapse or death due to any cause, whichever occurs first.
Up to Approximately 71 Months
Phase 2: Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ-C30) domains
大体时间：Up to Approximately 71 Months
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/Quality of Life (QoL) scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Up to Approximately 71 Months
Phase 3: Percentage of Participants with Transfusion Independence
大体时间：Up to Approximately 71 Months
Transfusion independence is defined as a period of at least 56 days with no red blood cell (RBC) and no platelet transfusion during the treatment period.
Up to Approximately 71 Months
Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence
大体时间：Up to Approximately 71 Months
Conversion from baseline transfusion dependence to post-baseline transfusion independence is defined as a period of at least 56 days with no RBC and no platelet transfusion during the treatment period among participants who were transfusion dependent within at least 28 days prior to study treatment.
Up to Approximately 71 Months
Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains
大体时间：Up to Approximately 71 Months
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Up to Approximately 71 Months
Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains
大体时间：Up to Approximately 71 Months
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Up to Approximately 71 Months
Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores
大体时间：Up to Approximately 71 Months
The EQ-5D-5L is a generic preference instrument that has been validated in numerous cancer populations. The EQ-5D-5L consists of 2 components: the descriptive system and the visual analog scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Up to Approximately 71 Months
Phase 3: Change from Baseline to the responses to FACT GP5
大体时间：Up to Approximately 71 Months
Functional Assessment of Cancer Therapy - General item GP5 (FACT GP5) item is a one-item questionnaire that is used to assess overall treatment tolerability in participants by assessing the overall side effect impact on participants. This item is rated on a 5-point Likert scale from 0 = "not at all" to 4 = "very much" using a 7-day recall period.
Up to Approximately 71 Months

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

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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)

2026年6月30日

初级完成 (估计的)

2032年6月1日

研究完成 (估计的)

2032年6月1日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • M26-092
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523724-47-00 (其他标识符：EU CT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共享时间框架

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 共享访问标准

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共享支持信息类型

  • 研究方案
  • 树液

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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