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New hope for AML patients: Triple-Drug combo targets Tough-to-Treat leukemia

NCT ID NCT07581002

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 21 times

Summary

This study tests whether adding pivekimab sunirine to the standard drugs venetoclax and azacitidine helps adults with newly diagnosed acute myeloid leukemia (AML) who are not healthy enough for intensive chemotherapy. About 660 participants will be randomly assigned to receive either the triple combination or standard care. The goal is to see if the new combo improves remission rates and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pivekimab sunirine, venetoclax, and azacitidine
What this could lead to
If successful, this combination could offer a new, more effective treatment option for AML patients who cannot tolerate intensive chemotherapy.
What could go wrong
This is an early-to-mid-stage trial, so the added benefit over standard care is unproven. Side effects from the combination may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 660 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center /ID# 279395

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Centre Hospitalier Universitaire D'Angers /ID# 280390

    RECRUITING

    Angers, Pays de la Loire Region, 49933, France

  • Centre Hospitalier Universitaire de Bordeaux /ID# 279001

    RECRUITING

    Pessac, New Aquitaine, 33604, France

  • China Medical University Hospital /ID# 279261

    RECRUITING

    Taichung, 40447, Taiwan

  • City of Hope National Medical Center /ID# 279568

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra - Pamplona /ID# 279516

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hadassah Medical Center-Hebrew University /ID# 278866

    RECRUITING

    Jerusalem, 91120, Israel

  • Hanusch-Krankenhaus /ID# 279467

    RECRUITING

    Vienna, State of Vienna, 1140, Austria

  • Hospital Universitario Puerta De Hierro /ID# 279660

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Linkou Chang Gung Memorial Hospital /ID# 279294

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Medizinische Universitaet Graz /ID# 278830

    RECRUITING

    Graz, Styria, 8010, Austria

  • Medizinische Universitaet Wien /ID# 278825

    RECRUITING

    Vienna, 1090, Austria

  • Moffitt Cancer Center /ID# 279192

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center - Moses Campus /ID# 279399

    RECRUITING

    The Bronx, New York, 10467, United States

  • National Taiwan University Hospital /ID# 279289

    RECRUITING

    Taipei, 100, Taiwan

  • Ordensklinikum Linz Elisabethinen /ID# 278824

    RECRUITING

    Linz, Upper Austria, 4010, Austria

  • Rabin Medical Center /ID# 278714

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 278719

    RECRUITING

    Haifa, 3109601, Israel

  • Samsung Medical Center /ID# 279397

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital /ID# 279634

    RECRUITING

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital /ID# 279396

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shaare Zedek Medical Center /ID# 278712

    RECRUITING

    Jerusalem, 9103102, Israel

  • Taichung Veterans General Hospital /ID# 279296

    RECRUITING

    Taichung, 407, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 278717

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The University of Texas MD Anderson Cancer Center /ID# 279402

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitaetsklinikum St. Poelten /ID# 278835

    RECRUITING

    Sankt Pölten, Lower Austria, 3100, Austria

  • Winship Cancer Institute of Emory University /ID# 279006

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yonsei University Health System Severance Hospital /ID# 279933

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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