Acute Myeloid LeukemiaPhase 2/3REVIVALNCT07581002
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)
A Phase 2/3 study testing Pivekimab Sunirine, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by AbbVie at 38 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Pivekimab Sunirine, Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 30 Jun 2026to Jun 2032
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- CD123-positive
- 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
Show all 22Show fewer
- 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.
- ECOG performance status 0 to 2 for subjects ≥ 75 years of age or 0 to 3 for subjects ≥ 18 to 74 years of age.
- 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).
- 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
Who cannot join
- 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.
Trial locations and contacts
38 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 7 countries
United States6 sites, 6 recruiting
- Recruiting
Winship Cancer Institute of Emory University /ID# 279006
Atlanta, Georgia, 30322
- Recruiting
City of Hope National Medical Center /ID# 279568
Duarte, California, 91010
- Recruiting
The University of Texas MD Anderson Cancer Center /ID# 279402
Houston, Texas, 77030
- Recruiting
Washington University /ID# 280295
St Louis, Missouri, 63110
- Recruiting
Moffitt Cancer Center /ID# 279192
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Center - Moses Campus /ID# 279399
The Bronx, New York, 10467
France6 sites, 6 recruiting
- Recruiting
CHU Amiens-Picardie Site Sud /ID# 280716
Amiens, Somme, 80054
- Recruiting
Centre Hospitalier Universitaire D'Angers /ID# 280390
Angers, Pays de la Loire Region, 49933
- Recruiting
Institut Paoli-Calmettes /ID# 279015
Marseille, Bouches-du-Rhone, 13273
- Recruiting
Chu de Nice-Hopital Larchet Ii /Id# 278998
Nice, Alpes-Maritimes, 06202
- Recruiting
Hopital Saint-Louis /ID# 279032
Paris, 75010
- Recruiting
Centre Hospitalier Universitaire de Bordeaux /ID# 279001
Pessac, New Aquitaine, 33604
Spain6 sites, 6 recruiting
- Recruiting
Hospital General Universitario Gregorio Maranon /ID# 279479
Madrid, 28007
- Recruiting
Md Anderson Cancer Center /ID# 279480
Madrid, 28033
- Recruiting
Hospital Universitario Puerta De Hierro /ID# 279660
Majadahonda, Madrid, 28222
- Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 279516
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Virgen del Rocio /ID# 279471
Seville, Sevilla, 41013
- Recruiting
Hospital Clinico Universitario de Valencia /ID# 279635
Valencia, 46010
Austria5 sites, 5 recruiting
- Recruiting
Medizinische Universitaet Graz /ID# 278830
Graz, Styria, 8010
- Recruiting
Ordensklinikum Linz Elisabethinen /ID# 278824
Linz, Upper Austria, 4010
- Recruiting
Universitaetsklinikum St. Poelten /ID# 278835
Sankt Pölten, Lower Austria, 3100
- Recruiting
Hanusch-Krankenhaus /ID# 279467
Vienna, State of Vienna, 1140
- Recruiting
Medizinische Universitaet Wien /ID# 278825
Vienna, 1090
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus- Haifa /ID# 278719
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center /ID# 278712
Jerusalem, 9103102
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 278866
Jerusalem, 91120
- Recruiting
Rabin Medical Center /ID# 278714
Petah Tikva, Central District, 4941492
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 278717
Tel Aviv, Tel Aviv, 6423906
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital /ID# 279634
Seongnam-si, Gyeonggido, 13620
- Recruiting
Seoul National University Hospital /ID# 279396
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Yonsei University Health System - Severance Hospital /ID# 279933
Seoul, Seoul Teugbyeolsi, 03722
- Recruiting
Asan Medical Center /ID# 279395
Seoul, Seoul Teugbyeolsi, 05505
- Recruiting
Samsung Medical Center /ID# 279397
Seoul, Seoul Teugbyeolsi, 06351
Taiwan5 sites, 5 recruiting
- Recruiting
China Medical University Hospital /ID# 279261
Taichung, 40447
- Recruiting
Taichung Veterans General Hospital /ID# 279296
Taichung, 407219
- Recruiting
National Taiwan University Hospital /ID# 279289
Taipei, 100
- Recruiting
Taipei Veterans General Hospital /ID# 281480
Taipei, 112
- Recruiting
Linkou Chang Gung Memorial Hospital /ID# 279294
Taoyuan City, 333
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Pivekimab Sunirine, Venetoclax, Azacitidine, Matching Placebo for PVEK
- Keywords
- Acute Myeloid Leukemia, Pivekimab Sunirine (PVEK), Azacitidine, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivekimab SunirineDrug
Intravenous
VenetoclaxDrug
Orally
AzacitidineDrug
Intravenous Or Subcutaneous
Matching Placebo for PVEKDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Arm A - PVEK, VEN, and AZA | Experimental | Participants will receive PVEK, VEN, and AZA Receives: Drug: Pivekimab Sunirine; Drug: Venetoclax; Drug: Azacitidine |
| Phase 2: Arm B - VEN and AZA | Active comparator | Participants will receive VEN and AZA Receives: Drug: Venetoclax; Drug: Azacitidine |
| Phase 3: Arm A - PVEK, VEN, and AZA | Experimental | Participants will receive PVEK, VEN, and AZA Receives: Drug: Pivekimab Sunirine; Drug: Venetoclax; Drug: Azacitidine |
| Phase 3: Arm B - PVEK-Placebo, VEN, and AZA | Experimental | Participants will receive PVEK-Placebo, VEN, and AZA Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Matching Placebo for PVEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Complete remission (CR)
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
Measured: Up to Approximately 71 Months
Phase 3: Complete remission (CR)
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
Measured: Up to Approximately 71 Months
Phase 3: Overall Survival (OS)
The time (in number of days) from randomization to death due to any cause.
Measured: Up to Approximately 71 Months
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.
Measured: Up to approximately 71 months
Secondary outcomes (9)
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
Measured: Up to Approximately 71 Months
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.
Measured: 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
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).
Measured: Up to Approximately 71 Months
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.
Measured: Up to Approximately 71 Months
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.
Measured: Up to Approximately 71 Months
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).
Measured: Up to Approximately 71 Months
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).
Measured: 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
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).
Measured: Up to Approximately 71 Months
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.
Measured: Up to Approximately 71 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Jun 2026
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581002
- Sponsor's protocol ID
- M26-092
- Other IDs
- 2025-523724-47-00, 2025
- Acronym
- REVIVAL
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.