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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)

11 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

660

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 2: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
Geneesmiddel: Pivekimab Sunirine
Intraveneus
Geneesmiddel: Venetoclax
Orally
Geneesmiddel: Azacitidine
Intravenous Or Subcutaneous
Actieve vergelijker: Phase 2: Arm B - VEN and AZA
Participants will receive VEN and AZA
Geneesmiddel: Venetoclax
Orally
Geneesmiddel: Azacitidine
Intravenous Or Subcutaneous
Experimenteel: Phase 3: Arm A - PVEK, VEN, and AZA
Participants will receive PVEK, VEN, and AZA
Geneesmiddel: Pivekimab Sunirine
Intraveneus
Geneesmiddel: Venetoclax
Orally
Geneesmiddel: Azacitidine
Intravenous Or Subcutaneous
Experimenteel: Phase 3: Arm B - PVEK-Placebo, VEN, and AZA
Participants will receive PVEK-Placebo, VEN, and AZA
Geneesmiddel: Venetoclax
Orally
Geneesmiddel: Azacitidine
Intravenous Or Subcutaneous
Geneesmiddel: Matching Placebo for PVEK
Intravenous

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 2: Complete remission (CR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 2 and Phase 3: Composite Response
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AbbVie

Onderzoekers

  • Studie directeur: ABBVIE INC., AbbVie

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juni 2026

Primaire voltooiing (Geschat)

1 juni 2032

Studie voltooiing (Geschat)

1 juni 2032

Studieregistratiedata

Eerst ingediend

6 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M26-092
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523724-47-00 (Andere identificatie: EU CT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren