Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations

NCT07789574 | Active Not Recruiting Phase 2

• 3 other identifiers: ESTIMATION2025-523491-23-002025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 50 patients will be enrolled from approximately 20 study sites in Germany.

Conditions

Chronic Myeloid Leukemia (CML)

Outcome Measures

Primary Outcomes (1)

• Rate of MR2 at 12 months

  rate of response after 12 months

  12 months after start of therapy

Study Arms (1)

asciminib 200 mg BID

EXPERIMENTAL

All patients will be treated with asciminib 200 mg BID

Drug: asciminib 200 mg BID

Interventions

asciminib 200 mg BID DRUG

All patients will be treated with asciminib 200 mg BID.

asciminib 200 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Thomas Ernst, PD Dr. med.: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

asciminib; BID protein, human

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)