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

NCT ID NCT07581002

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 5 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center /ID# 279395

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • China Medical University Hospital /ID# 279261

    RECRUITING

    Taichung, 40447, Taiwan

  • City of Hope National Medical Center /ID# 279568

    RECRUITING

    Duarte, California, 91010, United States

  • Hadassah Medical Center-Hebrew University /ID# 278866

    RECRUITING

    Jerusalem, 91120, Israel

  • Mayo Clinic Hospital - Phoenix /ID# 282904

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital Jacksonville /ID# 282903

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Montefiore Medical Center - Moses Campus /ID# 279399

    RECRUITING

    The Bronx, New York, 10467, United States

  • Rambam Health Care Campus- Haifa /ID# 278719

    RECRUITING

    Haifa, 3109601, Israel

  • Samsung Medical Center /ID# 279397

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, 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

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