Authorised Therapeutic exploratory (Phase II) Chronic Myeloid Leukemia

Frontline Asciminib combination in chronic phase CML

EU CTIS ID: 2024-516212-24-00

What this study is testing

Achievement of deep molecular response (MR4) with the combination of ATP competing BCR‐ABL1 inhibitors with asciminib in newly diagnosed CML patients

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Male or female patients with diagnosis of CP‐CML with cytogenetic confirmation of the Ph+ chromosome [t(9;22)(q34;q11)]
Serum lipase ≤1.5 x ULN
Written informed consent prior to any study procedures being performed
Ph‐negative cases or patients with variant translocations who are BCR‐ABL1 positive in multiplex PCR will be also considered eligible
ECOG performance status of ≤2
Age ≥ 18 years old (no upper age limit is given)

You likely can't join if

Allogeneic stem cell transplantation
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)

See the full eligibility criteria

Who can join

Male or female patients with diagnosis of CP‐CML with cytogenetic confirmation of the Ph+ chromosome [t(9;22)(q34;q11)]
Serum lipase ≤1.5 x ULN
Written informed consent prior to any study procedures being performed
Ph‐negative cases or patients with variant translocations who are BCR‐ABL1 positive in multiplex PCR will be also considered eligible
ECOG performance status of ≤2
Age ≥ 18 years old (no upper age limit is given)
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

What rules you out

Allogeneic stem cell transplantation
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)
Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib
Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
Patients unwilling or unable to comply with the protocol
Known impaired cardiac function, including any of the following: o Congenital long QT syndrome o History of or presence of clinically significant ventricular or atrial tachyarrhythmia o QTc >450 ms on screening ECG o Myocardial infarction within 12 months prior to starting therapy o History of clinically significant/ symptomatic bradycardia o Family history of idiopathic sudden death
Patients with resting QTcF ≥450 msec (male) or ≥460 msec (female) at pretreatment, or inability to determine the QTcF interval
Patients with uncorrected hypokalemia or hypomagnesemia
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)
History of acute or chronic pancreatitis

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.