Chronic Myeloid Leukemia (CML)Phase 2ESTIMATIONNCT07789574
Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations
A Phase 2 study testing asciminib 200 mg BID in people with Chronic Myeloid Leukemia (CML), run by Thomas Ernst, PD Dr. med. at 1 site in Germany.
Trial summary
This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 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?
- asciminib 200 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jun 2026to 31 Dec 2030
- Phase
- Phase 2
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
- Male or female patients with BCR::ABL1 positive CML in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven T315I mutations detected by Sanger sequencing or NGS.
- Age ≥ 18 years old (no upper age limit is given)
- ECOG performance status of ≤2.
- Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN [lower limit of normal] and ≤ULN [upper limit of normal]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
- AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia
- Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia
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- Total bilirubin ≤1.5 x ULN, except known Gilbert disease
- Serum creatinine ≤2 x ULN
- Written informed consent prior to any study procedures being performed
Who cannot join
- Pre-treatment with asciminib
- BCR::ABL1 variants lacking ABL1 exon a2
- Known impaired cardiac function, including any of the following:
- Congenital long QT syndrome
- History of or presence of clinically significant ventricular or atrial tachyarrhythmia
- QTc >450 msec on screening ECG
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- Myocardial infarction within 12 months prior to starting therapy
- Other clinically significant heart disease (e.g., unstable angina, congestive heart failure)
- Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled
- Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
- Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
- Known chronic pancreatitis
- Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
- Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential.
- Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug. (It is required that sexually active men use condom during intercourse while taking the drug and for 2 weeks after stopping treatment and not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of male patients must be advised to use highly effective methods of contraception.)
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- Active autoimmune disorder, including autoimmune hepatitis
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- hypersensitivity to the active ingredient asciminib or to any of the other ingredients listed according to the latest version of the SmPC
- Patients unwilling or unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 50 patients will be enrolled from approximately 20 study sites in Germany.
Read the detailed description
This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 50 patients will be enrolled from approximately 20 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. 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
- asciminib 200 mg BID
- 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.
asciminib 200 mg BIDDrug
All patients will be treated with asciminib 200 mg BID.
| Study group | Role | What they receive |
|---|---|---|
| asciminib 200 mg BID | Experimental | All patients will be treated with asciminib 200 mg BID Receives: Drug: asciminib 200 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MR2 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 posted27 Aug 2026
- Study start22 Jun 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Ernst, PD Dr. med.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Ernst, PD Dr. med., University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789574
- Sponsor's protocol ID
- ESTIMATION
- Other IDs
- 2025-523491-23-00, 2025
- Acronym
- ESTIMATION
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No