A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

Trial Title: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

NCT ID: NCT06368414

Condition: Chronic Myeloid Leukemia, Chronic Phase

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Asciminib

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Asciminib
Description: that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation
Arm group label: Asciminib arm

Summary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI

Detailed description: We expect that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2024

Completion date: August 31, 2028

Lead sponsor:
Agency: Korean Society of Hematology
Agency class: Other

Source: Korean Society of Hematology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06368414