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Study of efficacy and safety of asciminib in addition to imatinib in CML-CP patients without a deep level or response on imatinib
EU CTIS ID: 2024-515040-23-00
What this study is testing
The primary objective of this study is to assess whether asciminib 40 mg once daily (QD) + imatinib 400 mg QD or asciminib 60 mg QD + imatinib 400 mg QD is more effective than continued imatinib by testing the MR4.5 rate at 48 weeks.
- 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
- Signed informed consent must be obtained prior to participation in the study.
- Male or female patients ≥ 18 years of age with a confirmed diagnosis of CMLCP.
- Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 300 mg QD or higher).
- BCR-ABL1 levels > 0.01% IS and ≤ 1% IS at the time of study entry as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) at any time during prior imatinib treatment.
- Patient must meet the following laboratory values before randomization: • Absolute Neutrophil Count ≥ 1.5 x 109 L • Platelets ≥ 75 x 109/L • Hemoglobin ≥ 9 g/dL • Serum creatinine (sCr) < 1.5 mg/dL • Total bilirubin (TBL) ≤ 1.5 x upper limit of normal (ULN) except for patients with Gilbert’s syndrome who may only be included with total bilirubin ≤ 3.0 x ULN • Aspartate aminotransaminase (AST) ≤ 3.0 x ULN • Alanine aminotransaminase (ALT) ≤ 3.0 x ULN • Alkaline phosphatase (ALP) ≤ 2.5 x ULN • Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
- Patients must have the following laboratory values (≥ lower limit of normal (LLN)) or corrected to within normal limits with supplements prior to randomization: • Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance* within normal limits) • Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance* within normal limits) • Magnesium (magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance* within normal limits. *Creatinine clearance as calculated using Cockcroft-Gault formula
You likely can't join if
- Treatment failure according to ELN 2013 criteria during imatinib treatment.
- Known second chronic phase of CML after previous progression to accelerated phase/blast crisis (AP/BC).
- Previous treatment with any TKIs other than imatinib
- History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as: • History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to randomization • Concomitant clinically significant arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular (AV) block without a pacemaker • Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following • Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia • Concomitant medications with a "known" risk of Torsades de Pointes per qtdrugs.org that cannot be discontinued or replaced by safe alternative medication • inability to determine the QTcF interval
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase).
- History of acute pancreatitis within 1 year prior to randomization or past medical history of chronic pancreatitis or history of acute or chronic liver disease.
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study.
- Male or female patients ≥ 18 years of age with a confirmed diagnosis of CMLCP.
- Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 300 mg QD or higher).
- BCR-ABL1 levels > 0.01% IS and ≤ 1% IS at the time of study entry as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) at any time during prior imatinib treatment.
- Patient must meet the following laboratory values before randomization: • Absolute Neutrophil Count ≥ 1.5 x 109 L • Platelets ≥ 75 x 109/L • Hemoglobin ≥ 9 g/dL • Serum creatinine (sCr) < 1.5 mg/dL • Total bilirubin (TBL) ≤ 1.5 x upper limit of normal (ULN) except for patients with Gilbert’s syndrome who may only be included with total bilirubin ≤ 3.0 x ULN • Aspartate aminotransaminase (AST) ≤ 3.0 x ULN • Alanine aminotransaminase (ALT) ≤ 3.0 x ULN • Alkaline phosphatase (ALP) ≤ 2.5 x ULN • Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
- Patients must have the following laboratory values (≥ lower limit of normal (LLN)) or corrected to within normal limits with supplements prior to randomization: • Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance* within normal limits) • Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance* within normal limits) • Magnesium (magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance* within normal limits. *Creatinine clearance as calculated using Cockcroft-Gault formula
What rules you out
- Treatment failure according to ELN 2013 criteria during imatinib treatment.
- Known second chronic phase of CML after previous progression to accelerated phase/blast crisis (AP/BC).
- Previous treatment with any TKIs other than imatinib
- History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as: • History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to randomization • Concomitant clinically significant arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular (AV) block without a pacemaker • Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following • Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia • Concomitant medications with a "known" risk of Torsades de Pointes per qtdrugs.org that cannot be discontinued or replaced by safe alternative medication • inability to determine the QTcF interval
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase).
- History of acute pancreatitis within 1 year prior to randomization or past medical history of chronic pancreatitis or history of acute or chronic liver disease.
- History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- Taiwan
- Russian Federation
- Chile
- United States
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; Taiwan; Russian Federation; Chile; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.