Active, not recruitingPhase IIEN originalLeukemia

Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

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About the trial

This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej.
  • Nowo zdiagnozowana przewlekła białaczka szpikowa w fazie przewlekłej.
  • Choroba wykryta w ciągu ostatnich 6 miesięcy.
  • Przyjmowanie mniej niż 30 dni innego leku z grupy TKI w przeszłości.
  • Ogólny stan zdrowia pozwalający na udział w badaniu.
  • Dobre wyniki badań czynności narządów (wątroby, nerek, serca).

✗ Disqualifies

  • Nieprawidłowe wyniki badań wątroby (enzymy AST i ALT ponad 3 razy powyżej normy).
  • Nieprawidłowe wyniki badań nerek (eGFR poniżej 30 ml/min).
  • Problemy z ciśnieniem krwi, które nie są dobrze kontrolowane.
  • Wysoki poziom lipazy (enzym trzustkowy) powyżej normy.
  • Kobiety w wieku rozrodczym niechętne stosowaniu antykoncepcji.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (8)

University of Alabama at Birmingham

Birmingham, United States

Winship Cancer Institute Emory University

Atlanta, United States

Georgia Cancer Center at Augusta University

Augusta, United States

Karmanos Cancer Institute

Detroit, United States

Roswell Park Comprehensive Cancer Center

Buffalo, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Huntsman Cancer Institute

Salt Lake City, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, United States

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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