TriangleNCT04971226 · CITED IN SOURCE DOCUMENTS
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-08-28
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
Major Molecular Response at Week 96
Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE)
Major Molecular Response at Scheduled Data Collection Time Points
Major Molecular Response by Scheduled Data Collection Time Points
MR4.0 at Scheduled Data Collection Time Points
MR4.5 at All Scheduled Data Collection Time Points
MR4.0 by Scheduled Data Collection Time Points
MR4.5 by All Scheduled Data Collection Time Points
Complete Hematological Response (CHR) at All Scheduled Data Collection Time Points
Complete Hematological Response (CHR) by All Scheduled Data Collection Time Points
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96
Duration of MMR
Duration of MR4.0
Duration of MR4.5
Time to First MMR
Time to First MR4.0
Time to First MR4.5
BCR-ABL1≤1% at Scheduled Data Collection Time Points
BCR-ABL1≤1% by Scheduled Data Collection Time Points
Time to Treatment Failure (TTF)
Failure Free Survival (FFS)
Event Free Survival (EFS)
Progression Free Survival (PFS)
Overall Survival (OS)
Trough Plasma Concentrations.
Pharmacokinetics (PK) of Asciminib: Cmax
PK of Asciminib: Tmax
PK of Asciminib: AUCtau and AUClast
PK of Asciminib: CL/F
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria for treatment period: Participants eligible for inclusion in this study must meet all of the following criteria: * Male or female patients ≥ 18 years of age. * Participants with CML-CP within 3 months of diagnosis. * Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of 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 count ≥ 100 x 10\^9/L (≥ 100,000/mm\^3), * 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 \< 3 x ULN; patients with Gilbert's syndrome may only be included if total bilirubin ≤ 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 patients 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 * Ability to provide written informed consent 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. Exclusion Criteria for Treatment period: * 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, but no other 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 patients), ≥460 ms (female patients) 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 patient 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 www.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). Please refer to Section 6.3.1 * 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. * Known hypersensitivity to the study treatment Other protocol-defined Inclusion/exclusion criteria will apply. Inclusion Criteria for optional TFR period: Participants meeting the following additional criteria are not eligible to enter the TRI Period: * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures * A minimum of 5 years of study treatment up to maximum of 6 years of study treatment (i.e. participants are eligible to enter TFR any time between year 5 and year 6 of their study treatment * Sustained MR 4.0 (BCR::ABL1 IS ≤0.01%) or better, assessed by central laboratory for at least 2 years (equivalent to 104 weeks) which includes MR 4.5 (BCR::ABL1 IS ≤0.0032%) for at least 1 year (equivalent to 52 weeks) immediately prior to entry into the TFR Period, with the 5 last consecutive RQ-PCR (every 12 weeks) assessments at/or below MR 4.5. Entry into TFR Period should be no later than 12 weeks from the last MR 4.5 RQ-PCR assessment * Separate signed informed consent must be obtained prior to participation in the TFR Period Exclusion Criteria for optional TFR period: * Participants meeting the following additional criterion are not eligible for the inclusion in the optional TFR Period: * Participants in the treatment re-initiation (TRI) Period cannot re-enter TFR for a second TFR attempt Exclusion Criteria for Treatment Re-initiation (TRI) Period Participants meeting the following additional criterion are not eligible to enter the TRI Period: * In case of a pregnancy during the TFR Period, the pregnant woman must be discontinued upon loss of MMR (\>0.1% BCR::ABL1 IS at a single assessment) and cannot enter the TRI Period * Impaired cardiac function or cardiac repolarization abnormality * 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
- healthy Volunteers
- false
- maximum Age
- 100 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs
- intervention Names
- Drug: Asciminib
- label
- Asciminib
- type
- EXPERIMENTAL
- description
- Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food
- intervention Names
- Drug: Imatinib
- Drug: Nilotinib
- Drug: Bosutinib
- Drug: Dasatinib
- label
- Investigator selected TKIs
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Investigator selected TKIs
- description
- Comes in 100 mg and 400 mg tablets and taken orally
- name
- Imatinib
- other Names
- STI571
- type
- DRUG
- arm Group Labels
- Investigator selected TKIs
- description
- Comes in 150 mg and 200 mg capsules and taken orally
- name
- Nilotinib
- other Names
- AMN107
- type
- DRUG
- arm Group Labels
- Investigator selected TKIs
- description
- Comes in 100 mg and 400 mg tablets and taken orally
- name
- Bosutinib
- type
- DRUG
- arm Group Labels
- Investigator selected TKIs
- description
- Comes in 20 mg, 50 mg, 70 mg and 100 mg tablets and taken orally
- name
- Dasatinib
- type
- DRUG
- arm Group Labels
- Asciminib
- description
- Comes in 40 mg tablets and taken orally
- name
- Asciminib
- other Names
- ABL001
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 405
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- measure
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
- time Frame
- At 48 weeks
- description
- Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- measure
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)
- time Frame
- At 48 weeks
- secondary Outcomes
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- measure
- Major Molecular Response at Week 96
- time Frame
- at 96 weeks (96 weeks after last patient first dose)
- description
- TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to Adverse Event (AE). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date.
- measure
- Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE)
- time Frame
- 96 weeks after last patient first dose
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- measure
- Major Molecular Response at Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- measure
- Major Molecular Response by Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).
- measure
- MR4.0 at Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).
- measure
- MR4.5 at All Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).
- measure
- MR4.0 by Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).
- measure
- MR4.5 by All Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count \< 10 x 10\^9/L PLT count \< 450 x 10\^9/L Basophils \< 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes \< 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver
- measure
- Complete Hematological Response (CHR) at All Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count \< 10 x 10\^9/L PLT count \< 450 x 10\^9/L Basophils \< 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes \< 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver
- measure
- Complete Hematological Response (CHR) by All Scheduled Data Collection Time Points
- time Frame
- Planned total follow-up duration of 5 years
- description
- The CCyR response status was to be based on bone marrow assessment. Bone marrow examination for cytogenetic assessment was to be performed locally by the Investigator at baseline for all participants. Thereafter, during the course of the study, cytogenetic assessment was not mandatory and only performed if clinically indicated.
- measure
- Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96
- time Frame
- By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported later
- description
- Duration of MMR is defined as the time between the date of the first documented achievement of MMR and the earliest date of loss of MMR, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death
- measure
- Duration of MMR
- time Frame
- Planned total follow-up duration of 5 years
Full study description
- brief Summary
- The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.
- detailed Description
- This study is a phase III, multi-center, open-label, randomized study of oral asciminib 80 mg QD versus Investigator selected TKI (imatinib, nilotinib, dasatinib, or bosutinib) in adult patients with newly diagnosed Ph+ CML-CP. All comparator TKIs will be made available, unless not permitted by local regulations or local Health Authority or not approved for the treatment of CML in the country. Approximately 402 patients will be randomized in a 1:1 ratio to asciminib and Investigator selected TKI to join the treatment period. Randomization will be stratified based on the following two stratification factors: * ELTS score (low versus intermediate versus high) * Pre-randomization selected TKI (imatinib versus 2G TKI (nilotinib or dasatinib or bosutinib)). Prior to randomization, the Investigator, in consultation with the patient, considering the current treatment paradigm and patient characteristics and comorbidities, will make a selection of preference for imatinib or 2G TKI (nilotinib or dasatinib or bosutinib) if the patient is randomized to the comparator arm. The stratified randomization based on these two stratification factors will help to achieve a balance across the treatment arms for the possible comorbidities and baseline characteristics of patients enrolled in the study. To further ensure that the distribution of patients, between imatinib and 2G TKIs (nilotinib or dasatinib or bosutinib), in the Investigator selected TKI arm is reflective of the use of these agents in clinical practice, the enrollment into the strata of imatinib versus 2G TKI (nilotinib or dasatinib or bosutinib) based on the pre-randomization selection of TKI will be managed by Interactive Response Technology to be approximately 50% versus 50%. Treatment arms: The study will have 2 treatment arms: * Arm 1: asciminib 80 mg QD under fasting conditions * Arm 2: Investigator selected TKI that will include one of the below treatments: * Imatinib 400 mg QD administered with food * Nilotinib 300 mg BID administered under fasting conditions * Dasatinib 100 mg QD administered with or without meal * Bosutinib 400 mg QD administered with food. Apart from the treatment period described above, the present study comprises an optional Treatment-Free Remission (TFR) Period enrolling consenting participants of the treatment period (receiving asciminib or IS-TKI) who will discontinue their randomized treatment if they meet per protocol eligibility criteria. The optional TFR Period will last at least 2 years to assess the feasibility of TFR and TFR outcomes following discontinuation of their randomized treatment (asciminib or IS-TKI). In addition, during the TFR Period, participants who will lose major molecular response (MMR) must re-initiate treatment and will enter into a Treatment Reinitiation (TRI) Period. During the treatment period, no crossover of study treatment across arms and no change of study treatment within the Investigator selected TKI will be allowed. For specifically participants who must transition into the TRI Period, at the time of treatment re-initiation: a) participants who were previously treated with asciminib will resume asciminib at the same dose prior to entry into TFR. b) participants who were on IS-TKI may either continue with the same study treatment they were randomized to and at the same dose prior to entry into TFR or may switch to asciminib with a starting dose of 80 mg QD. Duration of Study treatment: Patients on the study will continue to receive the assigned treatment until the End of Study, premature discontinuation due to treatment failure, disease progression or intolerance, due to Investigator or participant decision. or due to patient going to TFR Period and/or TRI Period. Duration of study: The End of Study will occur 8 years from the last patient first treatment in the study. Patients who discontinue study treatment prematurely due to any reason, will be followed up for survival and progression (to AP/BC) until the End of Study.
Source references
- references
- citation
- Takahashi N, Kim DW, Kim I, Du X, Lee SE, Hu Y, Kikushige Y, Jiang Q, Wang Y, Chen S, Zhu H, Goto T, Tomita A, Ichii M, Nakamae H, Liu L, Liu B, Malek K, Zhu T, Wu S, Wang J. Asciminib Provides Better Efficacy and Favorable Safety and Tolerability Against Investigator-Selected Tyrosine Kinase Inhibitors in East Asian Patients With Newly Diagnosed Chronic Myeloid Leukemia: Results From a Subgroup Analysis of the Pivotal ASC4FIRST Study. Cancer Med. 2026 Jun;15(6):e72019. doi: 10.1002/cam4.72019.
- pmid
- 42339511
- type
- DERIVED
- citation
- Cortes JE, Hughes TP, Wang J, Kim DW, Kim DDH, Mayer J, Goh YT, le Coutre P, Etienne G, Kim I, Andorsky DJ, Bombaci F, Issa GC, Takahashi N, Kapoor S, Jinwal R, Malek K, McCulloch T, Yau L, Larson RA, Hochhaus A. Asciminib demonstrates superior efficacy and safety in newly diagnosed chronic myeloid leukemia in the ASC4FIRST trial. Blood. 2026 Mar 26;147(13):1433-1446. doi: 10.1182/blood.2025029210.
- pmid
- 41397287
- type
- DERIVED
- citation
- Hochhaus A, Wang J, Kim DW, Kim DDH, Mayer J, Goh YT, le Coutre P, Takahashi N, Kim I, Etienne G, Andorsky D, Issa GC, Larson RA, Bombaci F, Kapoor S, McCulloch T, Malek K, Yau L, Ifrah S, Hoch M, Cortes JE, Hughes TP; ASC4FIRST Investigators. Asciminib in Newly Diagnosed Chronic Myeloid Leukemia. N Engl J Med. 2024 Sep 12;391(10):885-898. doi: 10.1056/NEJMoa2400858. Epub 2024 May 31.
- pmid
- 38820078
- type
- DERIVED
- citation
- Cortes JE, Hochhaus A, Takahashi N, Larson RA, Issa GC, Bombaci F, Ramscar N, Ifrah S, Hughes TP. Asciminib monotherapy for newly diagnosed chronic myeloid leukemia in chronic phase: the ASC4FIRST phase III trial. Future Oncol. 2022 Dec;18(38):4161-4170. doi: 10.2217/fon-2022-0923. Epub 2022 Dec 16.
- pmid
- 36524980
- type
- DERIVED
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Discovery and provenance
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Preserved source evidence · Not medical advice