Chronic Myeloid Leukemia (CML)Phase 2ARTISTNCT07804901
Asciminib Frontline Risk Adapted
A Phase 2 study testing Dasatinib 80mg QD (5 days per week) and Standarc of Care in people with Chronic Myeloid Leukemia (CML), run by Prof. Dr. med. Andreas Hochhaus at 1 site in Germany.
Trial summary
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- Dasatinib 80mg QD (5 days per week) and Standarc of Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2027to 30 Jun 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the trial
- Newly diagnosed patients with BCR::ABL1+ CML-CP up to 12 weeks after diagnosis
- Evidence of any BCR::ABL1 transcript except transcripts lacking ABL1 exon a2.
- Male or female patients ≥ 18 years of age
- ECOG performance status of ≤2
- Diagnosis of CML-CP (ELN 2025 criteria)
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- Documented chronic phase CML will meet all the below criteria (Apperley et all 2025) with <20% blasts in PB and BM
- No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
- Adequate end organ function prior to randomization as defined by:
- Total bilirubin (TBL) < 3 x ULN; participants with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
- eGFR ≥ 30 mL/min/1.73m2 as calculated using the CKD-EPI 2021 equation
- 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 eGFR* ≥ 90 mL/min/1.73m2)
- 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 eGFR* ≥ 90 mL/min/1.73m2)
- Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with eGFR* ≥ 90 mL/min/1.73m2)
- For participants with mild to moderate renal impairment (eGFR* ≥ 30 mL/min/1.73m2 and < 90 mL/min/1.73m2) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization.
- eGFR as calculated using CKD-EPI 2021 equation
Who cannot join
- Previous treatment for CML or any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea for a maximum of 12 weeks or any TKI for a maximum of 2 weeks.
- BCR::ABL1 transcripts lacking ABL1 exon a2 (e.g., e13a3, e14a3, e1a3)
- 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 of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to starting study treatment.
- 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).
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- QTcF ≥ 450 ms on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF.
- 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 treatment 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 mellitus, 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 trial entry or patients who have not recovered from prior surgery.
- 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 history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection.
- History of Human Immunodeficiency Virus (HIV) infection unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatment (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery).
- Participation in a prior investigational trial within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
- Known hypersensitivity to the study treatment
- Pregnant or nursing (lactating) women
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking trial treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). Women of childbearing potential are excluded unless they are using highly effective methods of contraception while taking study treatment and for a period of time after stopping study medication.
- Highly effective contraception methods include (according to the CTCG - Recommendations related to contraception and pregnancy testing in clinical trials version 1.2.):
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).
- Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success
- Combined (estrogen and progesteron containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
- Progesteron-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking trial treatment.
- Women are considered post-menopausal 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 tubal ligation at least six weeks prior to enrollment on the trial. 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 trial treatment do not require contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Universitätsklinikum Jena
Jena, 07747
Andreas Hochhaus, Prof. Dr., +4936419396670, kim2-studienzentrale@med.uni-jena.de
About this study
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. The study will be conducted in Germany.
Read the detailed description
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. 200 patients will be enrolled from approximately 60 study sites in Germany.
Total maximum study duration is anticipated to be approximately 4 years. This includes an enrolment period of approximately 24 months and a minimum of 24 months of treatment with asciminib ± dasatinib. The study will continue for 24 months from the date of the last patient enrolled. Enrolled patients will be followed for the duration of the study, death or withdrawal from participation. Patients who discontinue treatment during the study will also be followed for the duration of the study, including those, who changed anticancer therapy. Patients who experience an AE within the 30 days post discontinuation will be followed in particular to determine the consequences of the AE.
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- Dasatinib 80mg QD (5 days per week), Standarc of Care
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib 80mg QD (5 days per week)Drug
Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib.
Standarc of CareDrug
Asciminib 80mg QD ist the usual standard of care therapy for CML
| Study group | Role | What they receive |
|---|---|---|
| asciminib 80 mg QD | Active comparator | Asciminb 80 mg QD is the usual standard of care for CML patients Receives: Drug: Standarc of Care |
| Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week) | Experimental | Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week, 4 weeks after start of asciminib. Receives: Drug: Dasatinib 80mg QD (5 days per week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MMR at 12 months
rate of response after 12 months
Measured: 12 months after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized but stratified; All patietns start with Asciminib, patients with standard risk factors commence in standard of Care, patients with risk factors start additional therapy with Dasatinib (in combination with Asciminib).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Andreas Hochhaus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Andreas Hochhaus, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804901
- Sponsor's protocol ID
- ARTIST
- Other IDs
- 2026-528103-13-00
- Acronym
- ARTIST
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asciminib Frontline Risk Adapted
- ClinicalTrials.gov ID
- NCT07804901
- Acronym / sponsor ID
- ARTIST / ARTIST
- Conditions
- Chronic Myeloid Leukemia (CML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Andreas HochhausUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. The study will be conducted in Germany.
Detailed description
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. 200 patients will be enrolled from approximately 60 study sites in Germany.
Total maximum study duration is anticipated to be approximately 4 years. This includes an enrolment period of approximately 24 months and a minimum of 24 months of treatment with asciminib ± dasatinib. The study will continue for 24 months from the date of the last patient enrolled. Enrolled patients will be followed for the duration of the study, death or withdrawal from participation. Patients who discontinue treatment during the study will also be followed for the duration of the study, including those, who changed anticancer therapy. Patients who experience an AE within the 30 days post discontinuation will be followed in particular to determine the consequences of the AE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized but stratified; All patietns start with Asciminib, patients with standard risk factors commence in standard of Care, patients with risk factors start additional therapy with Dasatinib (in combination with Asciminib).
| Arm | Type | Receives |
|---|---|---|
| asciminib 80 mg QD | Active comparator | Drug: Standarc of CareAsciminb 80 mg QD is the usual standard of care for CML patients |
| Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week) | Experimental | Drug: Dasatinib 80mg QD (5 days per week)Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week, 4 weeks after start of asciminib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent must be obtained prior to participation in the trial
- Newly diagnosed patients with BCR::ABL1+ CML-CP up to 12 weeks after diagnosis
- Evidence of any BCR::ABL1 transcript except transcripts lacking ABL1 exon a2.
- Male or female patients ≥ 18 years of age
- ECOG performance status of ≤2
Key exclusion criteria (32 listed)
- Previous treatment for CML or any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea for a maximum of 12 weeks or any TKI for a maximum of 2 weeks.
- BCR::ABL1 transcripts lacking ABL1 exon a2 (e.g., e13a3, e14a3, e1a3)
- 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:
- 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 mellitus, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib 80mg QD (5 days per week)Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. | Drug | Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week) |
| Standarc of CareAsciminib 80mg QD ist the usual standard of care therapy for CML | Drug | asciminib 80 mg QD |
Primary outcome
Rate of MMR at 12 months
Time frame: 12 months after start of therapy
rate of response after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib 80mg QD (5 days per week) and Standarc of Care in people with Chronic Myeloid Leukemia (CML), run by Prof. Dr. med. Andreas Hochhaus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Fabisch, Dr. (+49 3641 939 66 70, artist@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MMR at 12 months (time frame: 12 months after start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.