Asciminib for chronic phase CML with T315I mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm phase II trial enrolling about 50 adults with BCR-ABL1 T315I-positive CML in first or second chronic phase after allogeneic stem cell transplantation. All participants receive asciminib 200 mg twice daily and are followed for up to four years, including an enrollment period of ~24 months and at least 24 months of treatment. The study is non-randomized and does not include a control arm. Key safety and efficacy follow-up continues for the full study duration, including post-treatment observation for adverse events. Primary goal is to determine whether asciminib can provide clinical benefit in this specific mutation subset.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Uniklinik der RWTH Aachen
  Aachen, Germany Recruiting
• Universitätsklinikum Jena
  Jena, Germany Recruiting
• Universitätsklinikum Leipzig AöR
  Leipzig, Germany Recruiting
• Medizinische Fakultät Mannheim der Universität Heidelberg
  Mannheim, Germany Recruiting
• Universitätsklinikum Ulm
  Ulm, Germany Recruiting
• Charite CVK
  Berlin, Germany Not yet recruiting

Study contacts

• Study coordinator: Christian Fabisch, Dr.
• Email: estimation@med.uni-jena.de
• Phone: +49 3641 939 66 70

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using asciminib to treat chronic myeloid leukemia patients with a specific mutation

  This study is testing if a new drug called asciminib can help people with chronic myeloid leukemia who have a specific mutation and haven't had success with other treatments.

  Recruiting at 6 sites Phase 2 Novartis · Bordeaux and 5 other locations · NCT06514534

• Asciminib for Ph+ CML-CP in Germany: real-world patient experiences

  This real-world study tests how asciminib performs in adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, including those newly diagnosed or after one prior TKI.

  Recruiting at 74 sites Novartis · Baden-Baden, Baden-Wurttemberg and 73 other locations · NCT07549516

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Scemblix (asciminib) for newly diagnosed chronic-phase CML in China

  This project will try asciminib (Scemblix) in adults newly diagnosed with chronic-phase CML to see if it controls the disease and is safe.

  Recruiting Novartis · Wuhan, Hubei · NCT07375355

• Asciminib for children and teens with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase

  This study will try asciminib as a treatment for children aged 1 to under 18 with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, including newly diagnosed patients and those who are resistant or intolerant to prior TKIs, with or without the T315I mutation.

  Recruiting at 39 sites Phase 2 Novartis · Chicago, Illinois and 38 other locations · NCT07354074

• Early Tacrolimus Taper After Allogeneic Transplant

  This study tests whether stopping tacrolimus early after an allogeneic stem cell transplant is safe and feasible for people with AML, MDS, MF, CML, CMML, or GVHD risk after transplant.

  Recruiting Phase 1 Stanford University · Palo Alto, California · NCT07302776

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.