An observational study in CML, Chronic Phase; TKI, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.
964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 491 is above the median of 141 across 149 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib
4.Patients who must sign informed consent before screening
Exclusion Criteria:
flumatinib 600mg QD, fasting administration
Drug: Flumatinib Mesylate · Drug: Nilotinib Pill
nilotinib 300mg BID, fasting administration
Drug: Flumatinib Mesylate · Drug: Nilotinib Pill
Flumatinib mesylate tablets 600mg qd
Nilotinib Capsules 300mg bid
Major molecular response rate at 12 months
Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale
Time frame: 12 months
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive→
The First Affiliated Hospital of Soochow University