Treatment-free remission with asciminib plus TKIs in chronic-phase chronic myeloid leukemia

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 Phase 2 interventional protocol adds asciminib to patients' current TKI (imatinib, nilotinib, or dasatinib) for people with chronic-phase CML who previously failed a TKI cessation attempt. Eligible adults have been on a TKI for five years or more, lost MR3.0 after stopping TKIs, and then regained at least MR3.0 on a TKI retrial of at least 12 weeks with adequate organ function. Participants receive asciminib added to their TKI with the goal of achieving and maintaining MR4.5 for the protocol-specified duration before attempting treatment-free remission again, and TKIs will be restarted if MR3.0 is lost. The study is conducted at Gachon University Gil Medical Center in Incheon, South Korea, and is sponsored by the Korean Society of Hematology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 19 year or older
2. CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
3. Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
4. Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
5. Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
6. Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5
7. Adequate end organ function as defined by:

   * Total bilirubin (TBL) \< 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
   * Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula
   * 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
8. Patients who can sign the informed consent of their own free will

Exclusion Criteria:

1. Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
2. Patients who are receiving any other investigational agents.
3. Patients who currently have uncontrolled infections
4. Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
5. Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.
6. Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment.
7. Patients with active hepatitis B or C with uncontrolled disease activity.
8. Patients who have active malignancies requiring treatment other than CML.
9. Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study.
10. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
11. Pregnant women are excluded from this study Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib and TKIs, breastfeeding should be discontinued if the mother is treated with asciminib and TKIs.

Where it's running

• Gachon University Gil Medical Center
  Incheon, Incheon, South Korea Recruiting

Study contacts

• Study coordinator: Hawk Kim
• Email: ksh.cml.wp@gmail.com
• Phone: 82-10-8533-8019

Similar studies

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

• Potential of asciminib in early chronic‑phase CML

  This trial will see if asciminib alone, or asciminib plus nilotinib, helps adults newly diagnosed with chronic‑phase, BCR‑ABL–positive CML reach deep molecular responses and remain off treatment.

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• Asciminib for chronic phase CML with T315I mutation

  This study tests asciminib 200 mg twice daily in adults with chronic phase CML and a T315I mutation after stem cell transplant to see if it helps control leukemia.

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• 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

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  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

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.