This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. Patients with moderate to severe cardiac impairment will include those with moderate to severe cardiac conditions, who may have been excluded from previous acalabrutinib clinical trials and in whom the safety of acalabrutinib was not systematically assessed. The study is planned to take place in approximately 25 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team. An IDMC will be responsible for making recommendations for study continuation.
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
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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