Condition: CML, Chronic Phase · Chronic Myeloid Leukemia, Chronic Phase · Chronic Myeloid Leukemia, BCR/ABL-Positive · Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B). All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued. During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily. The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.
This description comes directly from the study's public registry record.
Paola Fazi · 0670390528 · p.fazi@gimema.it
Enrico Crea · 0670390514 · e.crea@gimema.it
Always discuss trial participation with your own doctor first.
| Hospital del Mar (Barcelona) | Barcelona, Spain | Recruiting |
| Hospital Universitario Basurto | Bilbao, Spain | Recruiting |
| Institut Català d'Oncologia Girona | Girona, Spain | Recruiting |
| Hospital Virgen de las Nieves | Granada, Spain | Recruiting |
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria, Spain | Recruiting |
| Hospital Gral U. Gregorio Marañón | Madrid, Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid, Spain | Recruiting |
| Hospital Universitario La Paz | Madrid, Spain | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia, Spain | Recruiting |
| Complejo Asistencial Universitario de Salamanca | Salamanca, Spain | Recruiting |
| Hospital Universitario La Fe Valencia | Valencia, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06409936