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)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified August 2026 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT07581002
Other Study ID Numbers:
M26-092
First Submitted
May 5, 2026
First Posted
May 11, 2026
Last Update Posted
September 3, 2026
Last Verified
August 2026

ClinicalTrials.gov processed this data on September 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Acute Myeloid Leukemia
Drug: Pivekimab SunirineDrug: VenetoclaxDrug: Pivekimab SunirineDrug: Venetoclax

Study Design

Study TypeInterventional
Actual Enrollment660 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateJune 29, 2026
Actual Primary Completion Date5yrs 7mos from now
Actual Study Completion Date5yrs 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Phase 2: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
Drug: Pivekimab Sunirine
Intravenous
Phase 2: Arm B - VEN and AZA
Participants will receive VEN and AZA
Drug: Venetoclax
Orally
Phase 3: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
Drug: Pivekimab Sunirine
Intravenous
Phase 3: Arm B - PVEK-Placebo, VEN, and AZA
Participants will receive PVEK-Placebo, VEN, and AZA
Drug: Venetoclax
Orally

Outcome Measures

Primary Outcome Measures
  1. Phase 2: Complete remission (CR)
    CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
  2. Phase 3: Complete remission (CR)
    CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
  3. Phase 3: Overall Survival (OS)
    The time (in number of days) from randomization to death due to any cause.
  4. Number of Participants with Adverse Events (AEs)
    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.
Secondary Outcome Measures
  1. Phase 2 and Phase 3: Composite Response
    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
  2. Phase 2 and Phase 3: Duration of CR (DoCR)
    Duration of CR (DoCR) defined as the time from achieving CR to hematologic relapse or death due to any cause, whichever occurs first.
  3. 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
    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).
  4. Phase 3: Percentage of Participants with Transfusion Independence
    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.
  5. Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence
    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.
  6. Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains
    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).
  7. Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains
    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).
  8. Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores
    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).
  9. Phase 3: Change from Baseline to the responses to FACT GP5
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
City of Hope National Medical Center /ID# 279568 | Duarte California, United States, 91010Moffitt Cancer Center /ID# 279192 | Tampa Florida, United States, 33612Winship Cancer Institute of Emory University /ID# 279006 | Atlanta Georgia, United States, 30322Montefiore Medical Center - Moses Campus /ID# 279399 | The Bronx New York, United States, 10467The University of Texas MD Anderson Cancer Center /ID# 279402 | Houston Texas, United States, 77030Universitaetsklinikum St. Poelten /ID# 278835 | Sankt Pölten Lower Austria, Austria, 3100Hanusch-Krankenhaus /ID# 279467 | Vienna State of Vienna, Austria, 1140Medizinische Universitaet Graz /ID# 278830 | Graz Styria, Austria, 8010Ordensklinikum Linz Elisabethinen /ID# 278824 | Linz Upper Austria, Austria, 4010Medizinische Universitaet Wien /ID# 278825 | Vienna , Austria, 1090Centre Hospitalier Universitaire D'Angers /ID# 280390 | Angers Pays de la Loire Region, France, 49933Rabin Medical Center /ID# 278714 | Petah Tikva Central District, Israel, 4941492Tel Aviv Sourasky Medical Center /ID# 278717 | Tel Aviv Tel Aviv, Israel, 6423906Rambam Health Care Campus- Haifa /ID# 278719 | Haifa , Israel, 3109601Shaare Zedek Medical Center /ID# 278712 | Jerusalem , Israel, 9103102Hadassah Medical Center-Hebrew University /ID# 278866 | Jerusalem , Israel, 91120Seoul National University Bundang Hospital /ID# 279634 | Seongnam-si Gyeonggido, South Korea, 13620Yonsei University Health System Severance Hospital /ID# 279933 | Seoul Seoul Teugbyeolsi, South Korea, 03722Asan Medical Center /ID# 279395 | Seoul Seoul Teugbyeolsi, South Korea, 05505Samsung Medical Center /ID# 279397 | Seoul Seoul Teugbyeolsi, South Korea, 06351Hospital Universitario Puerta De Hierro /ID# 279660 | Majadahonda Madrid, Spain, 28222China Medical University Hospital /ID# 279261 | Taichung , Taiwan, 40447Taichung Veterans General Hospital /ID# 279296 | Taichung , Taiwan, 407National Taiwan University Hospital /ID# 279289 | Taipei , Taiwan, 100Linkou Chang Gung Memorial Hospital /ID# 279294 | Taoyuan City , Taiwan, 333
Investigators
Study Director: ABBVIE INC., AbbVie