Chronic Myeloid Leukemia, Chronic Phase, Flumatinib, Imatinib
Conditions
Keywords
Flumatinib, CML-CP with Ph+
Brief summary
The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Detailed description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.
Interventions
DRUGFlumatinib
600 mg of Flumatinib orally daily for 24 months
Sponsors
Hainan General Hospital
Sanya Central Hospital
First Affiliated Hospital of Shantou University Medical College
Peking University Shenzhen Hospital
Dongguan People's Hospital
Shenzhen Second People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Diagnosis of CML-CP with Ph+. * ECOG performance of 0-2. * Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN. * Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%. * Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion criteria
* Previously documented T315I mutation. * History of TKI treatments except of imatinib. * History of undergone major surgery within 4 weeks. * Patients unwilling or unable to comply with the protocol. * Pregnant or breast-feeding patients. * patients with other malignant tumor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test. | 12 months | Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with MR 4.0 at 3, 6, 9, 12 months. | 3, 6, 9, 12 months. | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent. |
| Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. | 3, 6, 9, 12 months. | Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent. |
| Proportion of patients with MMR at 3, 6, 9 months. | 3, 6, 9 months | — |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib. | 24 months | Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges. |
Countries
China
Contacts
Primary ContactXin Du, Phd
Outcome results
None listed