Chronic Myeloid Leukemia
Conditions
Interventions
Experimental group:Receive treatment with Asenibuprofen
Sponsors
The Second People's Hospital of Shenzhen(The First Affiliated Hospital of Shenzhen University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in the study and signed the informed consent form. 2. Age >= 18 years old, both male and female are eligible. 3. Patients who were first diagnosed with Ph+ or BCR/ABL positive CML-CP according to the Chinese Diagnostic and Treatment Guidelines for Chronic Myeloid Leukemia (2020 Edition); Diagnosis definition: Positive Ph chromosome t(9;22) in bone marrow cytogenetics (observation of at least 20 interphase divisions) and/or positive BCR-ABL fusion gene (including rare atypical non-standard transcript types); The date of first diagnosis is defined as the sampling date on the first bone marrow cytogenetic or molecular report. The definition of chronic phase: All of the following 5 conditions must be met: = 1000×10^9/L or <100×10^9/L, but related to previous drug treatment; No extramedullary infiltration (except for hepatosplenomegaly). 4. Within 6 months after the diagnosis of CML. 5. Have received TKIs treatment for no more than 2 weeks previously. 6. Patients who need to receive Asunaprevir treatment according to the judgment of the treating doctor. 7. Female patients with reproductive capacity who have negative pregnancy test (screening period and baseline/first week blood pregnancy test).
Exclusion criteria
Exclusion criteria: 1.Received TKI therapy for more than 2 weeks prior to enrollment. 2.Received interferon therapy for more than 3 months prior to enrollment. 3.Received other anti-CML drugs (excluding hydroxyurea) for more than 2 weeks or undergone surgical treatment (including hematopoietic stem cell transplantation) prior to enrollment. 4.Currently participating in other clinical studies. 5.Undergone major surgery within 4 weeks or not recovered from surgery. 6.History of other malignancies, unless the primary malignancy has no current clinical significance or does not require active intervention. 7.Pregnant, lactating, or planning to become pregnant. 8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) >= 3. 9.Unable to comply with study procedures or follow-up schedule. 10.Known allergy or contraindication to the study drug (active pharmaceutical ingredient and/or excipients). 11.History of definite neurological or psychiatric disorders, including epilepsy or dementia. 12.Judged by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ultra-early molecular response rate of asciminib in newly diagnosed CML-CP patients.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving a =50% reduction in BCR::ABL1 IS from baseline at 6 weeks.;The rates of major molecular response (MMR) at 3, 6, 9, and 12 months.;the rates of deep molecular response (MR4, MR4.5) at 3, 6, 9, and 12 months.;The rates of complete cytogenetic response (CCyR) at 3, 6, 9, and 12 months.;The time to first achievement of MMR, MR4, MR4.5, or CCyR.;To determine the duration of MMR, MR4, MR4.5, and CCyR.;Progression-free survival (PFS) and overall survival (OS) at 12 months and beyond.;The occurrence of mutations in the ABL kinase region;Patient-reported outcome (PRO);Safety;To determine the time to treatment discontinuation due to adverse events (TTDAE) and corresponding reasons.;Compare the interruption rates and reasons for interruptions within 36 months between the Asciminib group and the first/second-generation TKIs group in ND CML- CP; | — |
Countries
China
Contacts
Public ContactXin Du
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
Outcome results
None listed