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A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
EU CTIS ID: 2023-508838-33-00
What this study is testing
To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of participants that are in Major Molecular Response (MMR) at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within the stratum of participants with imatinib as the pre-randomization selected TKI, with respect to the proportion of participants that are in MMR at Week 48.
- Therapeutic confirmatory (Phase III)
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 participants ≥ 18 years of age.
- Participants with CML-CP within 3 months of diagnosis.
- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome • Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020): • < 15% blasts in peripheral blood and bone marrow, • < 30% blasts plus promyelocytes in peripheral blood and bone marrow, • < 20% basophils in the peripheral blood, • Platelet (PLT) count ≥ 100 x 109/L (≥ 100,000/mm3), • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate end organ function as defined by: • Total bilirubin (TBL) < 3 x upper limit of normal (ULN); participants with Gilbert’s syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN • Creatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula • 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
- Participants must have the following laboratory values within normal limits 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 CrCl* ≥ 90 mL/min) • 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 CrCl* ≥ 90 mL/min) • Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min) • For participants with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization. • CrCl* as calculated using Cockcroft-Gault formula
You likely can't join if
- Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤ 2 weeks is allowed. No treatment with other tyrosine kinase inhibitors prior to randomization is permitted.
- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: • History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG). • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block). • QTc ≥ 450 ms (male participants), ≥ 460 ms (female participants) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the participant re-screened for QTc. • 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 (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. • Concomitant medication(s) with a “Known risk of Torsades de Pointes” per //.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug 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 arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
See the full eligibility criteria
Who can join
- Male or female participants ≥ 18 years of age.
- Participants with CML-CP within 3 months of diagnosis.
- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome • Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020): • < 15% blasts in peripheral blood and bone marrow, • < 30% blasts plus promyelocytes in peripheral blood and bone marrow, • < 20% basophils in the peripheral blood, • Platelet (PLT) count ≥ 100 x 109/L (≥ 100,000/mm3), • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate end organ function as defined by: • Total bilirubin (TBL) < 3 x upper limit of normal (ULN); participants with Gilbert’s syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN • Creatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula • 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
- Participants must have the following laboratory values within normal limits 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 CrCl* ≥ 90 mL/min) • 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 CrCl* ≥ 90 mL/min) • Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min) • For participants with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization. • CrCl* as calculated using Cockcroft-Gault formula
- Signed informed consent must be obtained prior to any study related screening procedures being performed.
- Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification.
What rules you out
- Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤ 2 weeks is allowed. No treatment with other tyrosine kinase inhibitors prior to randomization is permitted.
- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: • History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG). • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block). • QTc ≥ 450 ms (male participants), ≥ 460 ms (female participants) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the participant re-screened for QTc. • 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 (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. • Concomitant medication(s) with a “Known risk of Torsades de Pointes” per //.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug 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 arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
- History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
- History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
- History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Japan
- Canada
- United States
- Australia
- India
- Israel
- Switzerland
- Taiwan
- Singapore
- Malaysia
- United Kingdom
- China
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; Japan; Canada; United States; Australia; India and 7 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.