A Phase 3 interventional study of Asciminib and Nilotinib in Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 119 sites in 24 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 21 studies testing asciminib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive — 8 open to participants now, 13 under way, 2 of them phase 3. asciminib · Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Among the 21 studies testing asciminib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive, this one has the largest enrollment, is one of 3 that started in 2022, is one of 5 in phase 3, reaches primary completion later than 1 of the 12 other live ones, and was the 15th registered.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →8 of the 21 studies testing asciminib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive are open now, in 12 countries. Recruiting first, the newest first:
Thomas Ernst, Prof. Dr. med. · Sites in Germany
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Australia, Brazil and 14 more countries
Ages 1–18
Gruppo Italiano Malattie EMatologiche dell'Adulto · Sites in Spain
Ages 18+
Novartis Pharmaceuticals · Sites in France
Ages 18–99
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
asciminib: first FDA approval 2021 (SCEMBLIX), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 79 Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies recruiting now, 48 (61%) set no upper age limit and 20 (25%) stop at 75 or younger; 20 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 12 · Phase 3 5 · Phase 4 2
First in 2014; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 568 is above the median of 44 across 681 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Median enrollment 100 across the 21 interventional studies. Of the 8 that completed or were terminated, 4 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 21 have an industry lead sponsor. The 9 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
92 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive by Novartis: 9 open now, 13 under way, 2 of them phase 3. Of 73 finished, 35 (48%) have results posted.
Among the 92 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive by Novartis, this one is the 4th largest by enrollment of the 63 interventional ones that give a count, is one of 5 that started in 2022, is one of 19 in phase 3, reaches primary completion later than 1 of the 12 other live ones, and was the 71st registered.
Novartis’s Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies by the year they started, since 1999.
2 of the studies testing asciminib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03906292University of JenaFrontline Asciminib Combination in Chronic Phase CML | 2027-03 |
| NCT04925479Novartis PharmaceuticalsStudy to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia | 2027-09-03 |
Add all 2 to your calendar (.ics) → With an account.
Among the 21 studies testing asciminib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive, from their registry updates:
Among Novartis’s 92 in Leukemia, Myelogenous, Chronic, BCR-ABL Positive:
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The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
The study is designed to compare the tolerability of asciminib with nilotinib for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP and has 3 phases: Treatment Phase, Optional Treatment-Free Remission (TFR) Phase, and Treatment Re-initiation (TRI) Phase.
Participants were randomized in the study in a 1:1 ratio to asciminib or nilotinib. No crossover of study treatment across arms were allowed.
Randomization was stratified based on European Treatment Outcome Study (EUTOS) long-term survival (ELTS) score (low versus intermediate versus high) to help achieve a balance between the treatment arms.
An interim analysis was planned in the protocol when 46 discontinuations due to AE occurred. The purpose of the interim analysis was to allow an early assessment of the tolerability of asciminib and the goal was to continue to primary analysis regardless of the outcome of the interim analysis. Therefore, following the interim analysis, the primary analysis was performed when approximately 65 discontinuations of either study treatment due to Adverse Event (AE) occurred.
Eligible participants on both arms may choose to participate in an optional 2-year Treatment Free Remission (TFR) Phase. Participants with loss of Major Molecular Response (MMR) during TFR Phase will enter the Treatment Re-initiation (TRI) Phase. Additionally, treatment re-initiation in the TRI Phase may be based on investigator or participant decision.
Key Inclusion Criteria:
Diagnosis of CML-CP (European Leukemia Network [ELN] 2020 criteria) with cytogenetic confirmation of the Philadelphia (Ph) chromosome. A cryptic Ph chromosome should be confirmed by metaphase Fluorescence in situ Hybridization (FISH) • Documented chronic phase CML will meet all the below criteria (Baccarani et al 2013): \~ \< 15% blasts in peripheral blood and bone marrow,
\~ \< 30% blasts plus promyelocytes in peripheral blood and bone marrow,
\~\< 20% basophils in the peripheral blood,
Adequate end organ function as defined by:
Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:
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 within normal limits or corrected to within normal limits with supplements prior to randomization.
CrCl as calculated using Cockcroft-Gault formula.
Inclusion Criteria for optional Treatment Free Remission (TFR) Phase:
Key Exclusion Criteria:
Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:
Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Highly effective contraception methods include:
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Women are considered if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate history of vasomotor symptoms). Women are considered not of child bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to enrollment on the study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child bearing potential.
Sexually active males taking study treatment do not require contraception. - Known to the study treatment. Note: The Investigator has the discretion to include/exclude a patient in the study, who will be found to have symptoms representative of coronavirus disease of 2019 (COVID-19) or tested positive for COVID-19 during the screening phase. Such patients should be managed as per the country specific guidelines related to COVID-19. For patients who test positive for COVID-19, re-testing is recommended before initiating study treatment.
Exclusion Criteria for optional Treatment Free Remission (TFR) Phase:
Exclusion criteria for Treatment Re-initiation (TRI) Phase
Relevant exclusion criteria for treatment phase apply including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received asciminib 80 mg once a day (QD).
Drug: Asciminib
Participants will receive nilotinib 300 mg BID
Drug: Nilotinib
Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
Time frame: From date of first dose to date of treatment discontinuation due to AE, assessed after 50 events had occurred, about 2 years since first patient first visit (FPFV).
Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Primary Analysis)
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
Time frame: From date of first dose to date of treatment discontinuation due to AE, assessed after 67 events had occurred, about 2.5 years since first patient first visit (FPFV),
Percentage of Participants With Major Molecular Response (MMR) at Scheduled Data Collection Time Points
MMR will be assessed using fusion gene of the BCR and ABL genes (BCR-ABL) transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MMR at each time point will be assessed.
Time frame: approximately 7.5 years
Percentage of Participants With Major Molecular Response (MMR) by Scheduled Data Collection Time Points
MMR will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MMR) at or before the specified visit will be calculated.
Time frame: approximately 7.5 years
Percentage of Participants With MR4.0 at Scheduled Data Collection Time Points
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.0 at each time point will be assessed.
Time frame: approximately 7.5 years
Percentage of Participants With MR4.0 by Scheduled Data Collection Time Points
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.0) at or before the specified visit will be calculated
Time frame: approximately 7.5 years
Percentage of Participants With MR4.5 at Scheduled Data Collection Time Points
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.5 at each time point will be assessed.
Time frame: approximately 7.5 years
Percentage of Participants With MR4.5 by Scheduled Data Collection Time Points
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.5) at or before the specified visit will be calculated
Time frame: approximately 7.5 years
Percentage of Participants With Complete Hematological Response (CHR) at Scheduled Data Collection Time Points
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants with CHR at each time point will be assessed.
Time frame: approximately 7.5 years
Percentage of Participants With Complete Hematological Response (CHR) by Scheduled Data Collection Time Points
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants who meet the criteria for having achieved the endpoint (CHR) at or before the specified visit will be calculated
Time frame: approximately 7.5 years
Percentage of Participants With BCR::ABL1 Ratio ≤1% at Scheduled Data Collection Time Points
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at the specified visit will be calculated
Time frame: approximately 7.5 years
Percentage of Participants With BCR::ABL1 Ratio ≤1% by Scheduled Data Collection Timepoints
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at or before the specified visit will be calculated
Time frame: approximately 7.5 years
Duration of MMR
Duration of MMR is defined as the time between the date of the first documented achievement MMR and the earliest date of loss of MMR, treatment failure, progression to AP/BC, or CML-related death.
Time frame: approximately 7.5 years
Duration of MR4.0
Duration of MR4.0 is defined as the time between the date of the first documented achievement MR4 and the earliest date of loss of MR4, treatment failure, progression to AP/BC, or CML-related death
Time frame: approximately 7.5 years
Duration of MR4.5
Duration of MR4.5 is defined as the time between the date of the first documented achievement MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to AP/BC, or CML-related death.
Time frame: approximately 7.5 years
Time to First MMR
Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR.
Time frame: approximately 7.5 years
Time to First MR4.0
Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.
Time frame: approximately 7.5 years
Time to First MR4.5
Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5.
Time frame: approximately 7.5 years
Time to Treatment Failure (TTF).
TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: * Treatment failure per European leukemia network (ELN) criteria, * Confirmed loss of MMR (in 2 consecutive tests) at any time while on study treatment, * Discontinuation from study treatment due to any reason
Time frame: approximately 7.5 years
Event Free Survival (EFS)
EFS is defined as the time from the date of the first dose of study treatment to the earliest occurrence of treatment failure, confirmed lost of MMR, discontinuation due to AE, progression to AP/BC, and death from any cause.
Time frame: approximately 7.5 years
Progression Free Survival (PFS).
PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.
Time frame: approximately 7.5 years
Overall Survival (OS).
OS is defined as the time from the date of randomization to the date of death from any cause.
Time frame: approximately 7.5 years
Time to Treatment Discontinuation (TTD) Due to Selected Reasons
TTD is the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to lack of efficacy, treatment failure, disease progression, suboptimal response or death
Time frame: approximately 7.5 years
Change From Baseline in Overall Scores and Individual Scales of the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-C30. The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures based on the participant's experience over the past week. These include five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Time frame: approximately 7.5 years
Change From Baseline in Overall Scores and Individual Scales of the European Organization for Research and Treatment of Cancer CML Module (EORTC QLQ-CML24)
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-CML24. The EORTC QLQ-CML24 assesses specific concepts relevant to the experience of patients with CML. The QLQ-CML24 has 24 items which assess symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life based on the participant's experience over the past week.
Time frame: approximately 7.5 years
568 participants with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) were enrolled into this study from 120 sites in 24 countries.
| Milestone | Asciminib | Nilotinib |
|---|---|---|
| Started | 284 | 284 |
| Participants treated | 284 | 282 |
| Participants not treated | 0 | 2 |
| Completed | 234 | 204 |
| Not completed | 50 | 80 |
| Withdrew: Adverse event | 20 | 44 |
| Withdrew: Unsatisfactory therapeutic effect | 19 | 21 |
| Withdrew: Progressive disease | 3 | 1 |
| Withdrew: Physician decision | 2 | 3 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Withdrawal of informed consent | 1 | 0 |
| Withdrew: Pregnancy | 0 | 2 |
| Withdrew: Requires prohibited medication | 0 | 1 |
| Withdrew: Technical problems | 0 | 1 |
| Withdrew: Participants not treated | 0 | 2 |
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
| Participants | Asciminib | Nilotinib |
|---|---|---|
| Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis) | 16 | 34 |
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
| Participants | Asciminib | Nilotinib |
|---|---|---|
| Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Primary Analysis) | 22 | 45 |
MMR will be assessed using fusion gene of the BCR and ABL genes (BCR-ABL) transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MMR at each time point will be assessed.
Results for this outcome have not been posted.
MMR will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MMR) at or before the specified visit will be calculated.
Results for this outcome have not been posted.
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.0 at each time point will be assessed.
Results for this outcome have not been posted.
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.0) at or before the specified visit will be calculated
Results for this outcome have not been posted.
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.5 at each time point will be assessed.
Results for this outcome have not been posted.
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.5) at or before the specified visit will be calculated
Results for this outcome have not been posted.
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants with CHR at each time point will be assessed.
Results for this outcome have not been posted.
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants who meet the criteria for having achieved the endpoint (CHR) at or before the specified visit will be calculated
Results for this outcome have not been posted.
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at the specified visit will be calculated
Results for this outcome have not been posted.
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at or before the specified visit will be calculated
Results for this outcome have not been posted.
Duration of MMR is defined as the time between the date of the first documented achievement MMR and the earliest date of loss of MMR, treatment failure, progression to AP/BC, or CML-related death.
Results for this outcome have not been posted.
Duration of MR4.0 is defined as the time between the date of the first documented achievement MR4 and the earliest date of loss of MR4, treatment failure, progression to AP/BC, or CML-related death
Results for this outcome have not been posted.
Duration of MR4.5 is defined as the time between the date of the first documented achievement MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to AP/BC, or CML-related death.
Results for this outcome have not been posted.
Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR.
Results for this outcome have not been posted.
Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.
Results for this outcome have not been posted.
Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5.
Results for this outcome have not been posted.
TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: * Treatment failure per European leukemia network (ELN) criteria, * Confirmed loss of MMR (in 2 consecutive tests) at any time while on study treatment, * Discontinuation from study treatment due to any reason
Results for this outcome have not been posted.
EFS is defined as the time from the date of the first dose of study treatment to the earliest occurrence of treatment failure, confirmed lost of MMR, discontinuation due to AE, progression to AP/BC, and death from any cause.
Results for this outcome have not been posted.
PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.
Results for this outcome have not been posted.
OS is defined as the time from the date of randomization to the date of death from any cause.
Results for this outcome have not been posted.
TTD is the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to lack of efficacy, treatment failure, disease progression, suboptimal response or death
Results for this outcome have not been posted.
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-C30. The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures based on the participant's experience over the past week. These include five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Results for this outcome have not been posted.
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-CML24. The EORTC QLQ-CML24 assesses specific concepts relevant to the experience of patients with CML. The QLQ-CML24 has 24 items which assess symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life based on the participant's experience over the past week.
Results for this outcome have not been posted.
Collected over Adverse Events (AEs) were reported from the first dose of study treatment until end of treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until data cut-off on 15-May-2025 (approx. 2.5 years).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asciminib | 2/284 (0.7%) | 47/284 (16.5%) | 213/284 (75%) |
| Nilotinib | 1/282 (0.4%) | 42/282 (14.9%) | 235/282 (83.3%) |
| All Participants | 3/566 (0.5%) | 89/566 (15.7%) | 448/566 (79.2%) |
| Event | Asciminib | Nilotinib | All Participants |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 2/284 | 5/282 | 7/566 |
| PancreatitisGastrointestinal disorders | 1/284 | 3/282 | 4/566 |
| Pancreatitis acuteGastrointestinal disorders | 0/284 | 3/282 | 3/566 |
| Drug-induced liver injuryHepatobiliary disorders | 0/284 | 3/282 | 3/566 |
| PneumoniaInfections and infestations | 3/284 | 1/282 | 4/566 |
| Atrial fibrillationCardiac disorders | 0/284 | 2/282 | 2/566 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/284 | 0/282 | 2/566 |
| Acute left ventricular failureCardiac disorders | 0/284 | 1/282 | 1/566 |
| Acute myocardial infarctionCardiac disorders | 0/284 | 1/282 | 1/566 |
| Arteriospasm coronaryCardiac disorders | 0/284 | 1/282 | 1/566 |
| Event | Asciminib | Nilotinib | All Participants |
|---|---|---|---|
| RashSkin and subcutaneous tissue disorders | 33/284 | 48/282 | 81/566 |
| ThrombocytopeniaBlood and lymphatic system disorders | 46/284 | 40/282 | 86/566 |
| Alanine aminotransferase increasedInvestigations | 15/284 | 42/282 | 57/566 |
| HeadacheNervous system disorders | 38/284 | 41/282 | 79/566 |
| Blood bilirubin increasedInvestigations | 6/284 | 39/282 | 45/566 |
| FatigueGeneral disorders | 32/284 | 35/282 | 67/566 |
| MyalgiaMusculoskeletal and connective tissue disorders | 35/284 | 26/282 | 61/566 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 22/284 | 32/282 | 54/566 |
| NauseaGastrointestinal disorders | 32/284 | 21/282 | 53/566 |
| DiarrhoeaGastrointestinal disorders | 31/284 | 24/282 | 55/566 |
The Full analysis set (FAS) comprises all participants to whom study treatment has been assigned by randomization.
| Age, Continuous(years) | Asciminib | Nilotinib | Total |
|---|---|---|---|
| Mean | 48.3 ± 14.74 | 48.8 ± 15.04 | 48.6 ± 14.88 |
| Sex: Female, Male(Participants) | Asciminib | Nilotinib | Total |
|---|---|---|---|
| Female | 107 | 126 | 233 |
| Male | 177 | 158 | 335 |
| Race/Ethnicity, Customized(Participants) | Asciminib | Nilotinib | Total |
|---|---|---|---|
| White | 227 | 217 | 444 |
| Asian | 40 | 46 | 86 |
| Black or African American | 12 | 10 | 22 |
| Not reported | 2 | 6 | 8 |
| Unknown | 2 | 1 | 3 |
| American Indian or Alaska Native | 1 | 1 | 2 |
| Multiple | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
Showing the first 100 of 119 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Nov 2022 to primary completion in May 2025, 29 months.
Results were first posted in May 2026, 1 year after primary completion.
Of 24 phase 3 interventional studies under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 79. This study's 29 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Asciminib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive →