Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 2

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

50 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 50 patients will be enrolled from approximately 20 study sites in Germany.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• Male or female patients with BCR::ABL1 positive CML in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven T315I mutations detected by Sanger sequencing or NGS.
• Age ≥ 18 years old (no upper age limit is given)
• ECOG performance status of ≤2.
• Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN \[lower limit of normal\] and ≤ULN \[upper limit of normal\]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
• AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia
• Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia
• Total bilirubin ≤1.5 x ULN, except known Gilbert disease
• Serum creatinine ≤2 x ULN
• Written informed consent prior to any study procedures being performed

Exclusion Criteria:

• Pre-treatment with asciminib
• BCR::ABL1 variants lacking ABL1 exon a2
• Known impaired cardiac function, including any of the following:

• Congenital long QT syndrome
• History of or presence of clinically significant ventricular or atrial tachyarrhythmia
• QTc \>450 msec on screening ECG
• Myocardial infarction within 12 months prior to starting therapy
• Other clinically significant heart disease (e.g., unstable angina, congestive heart failure)
• Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores \>6), even if controlled
• Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
• Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
• Known chronic pancreatitis
• Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
• Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential.
• Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug. (It is required that sexually active men use condom during intercourse while taking the drug and for 2 weeks after stopping treatment and not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of male patients must be advised to use highly effective methods of contraception.)
• Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
• Active autoimmune disorder, including autoimmune hepatitis
• Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
• hypersensitivity to the active ingredient asciminib or to any of the other ingredients listed according to the latest version of the SmPC
• Patients unwilling or unable to comply with the protocol.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (10)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

10 centros

Equipo y fechas

Patrocinador principal

Thomas Ernst, Prof. Dr. med.

Inicio del estudio

2026-11 Estimado

Finalización primaria

30 jun 2030 Estimado

Finalización del estudio

31 dic 2030 Estimado

Primera publicación

27 ago 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio