Acute myeloid leukemia
Conditions
Interventions
150mg BID:Oral sklb1028 capsule 150mg bid
200mg BID:Oral sklb1028 capsule 200mg bid
300mg QD:Oral sklb1028 capsule 300mg QD
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer and sign informed consent forms; 2. Male or female Chinese patients, aged >=18 years old; 3. In patients with primary or secondary aml diagnosed according to (who) classification of the World Health Organization, patients with FLT3 mutation were detected by leukemia cell gene, and refractory aml; after at least one cycle of induction treatment of: (1) met any of the following conditions; (2) recurrent aml; after at least one cycle of induction therapy; 4. Ecog score 0-3; 5. Expected survival time greater than 3 months; 6. The study drug was at least 2 weeks apart from prior cytotoxic chemotherapy (except for hydroxyl groups), or at least 5 half-lives or 4 weeks with prior non-cytotoxic chemotherapy agents, short-term; 7. Upper limit of normal value of serum creatinine <=1.5 times; 8. The upper limit of the normal value of total bilirubin <=1.5 times, except for gilbert's syndrome and leukemia involving organs; 9. Upper limit of serum AST, ALT <=3.0 times normal value, except where leukemia involves organs; 10. The subjects of childbearing age agreed to take effective contraceptives during the treatment and 6 months after the completion of the treatment.
Exclusion criteria
Exclusion criteria: 1. Diagnosed acute promyelocytic leukemia; 2. Recent symptomatic central neurosystemic leukemia; 3. There are grade 2 or more non-hematological toxicity caused by previous chemotherapy; 4. Bone marrow transplants within 100 days of the study; 5. Uncontrollable active infections (acute or chronic fungi, bacteria, viruses, or other infections); 6. Major surgical treatment of major organs was performed in the first 4 weeks of the study; 7. Radiotherapy was performed within 4 weeks before entering the study; 8. Cardiac ejection fraction below 50% or below the lower limit of normal value; patients with prolonged history of qtc (male > 450 Ms, female > 470ms); severe history of heart; 9. Hiv positive; 10. Active hepatitis B virus infection (hepatitis B virus surface antigen positive and hepatitis B dna quantity >=1 x10^3 copies/ml), hepatitis C virus infection or other liver diseases; 11. Pregnant or lactating women; 12. There are serious diseases or complications, or diseases that the researchers determine may endanger the safety of the patient or interfere with the study; 13. Patients who are not considered to be able to enter the study; 14. Treatment is currently under way in another clinical trial or in another clinical trial within four weeks of the commencement of SKLB1028 treatment; 15. Patients who have previously received sklb1028 or other FLT3 inhibitors (midostaurin,gilteritinib, quizartinib).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total remission rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total survival time (OS);Progression-free survival time (PFS);Incidence of adverse events (type and frequency of adverse events (teae) during treatment, evaluation of toxicity level of adverse events according to nci-ctcae (version 5.0);Vital signs;12-lead ECG;physical examination;ECOG;laboratory examination; | — |
Contacts
Public ContactLiu Ting
West China Hospital, Sichuan University
Outcome results
None listed