Status:
UNKNOWN
A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients will receive oral SKLB1028 for 28 days as a course of treatment, and then to evaluate the side effects,tolerability and best dose for treating relapsed or refractory acute myeloid leukemia Wi...
Detailed Description
It is an open,multicenter,queue extension study designed to characterize the efficacy and safety of different administration regimens of SKLB1028 capsules in patients with recurrent/refractory acute m...
Eligibility Criteria
Inclusion
- Volunteer and sign informed consent forms
- Male or female Chinese patients, age ≥ 18 years old
- 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: a) met any of the following conditions. B) recurrent aml; after at least one cycle of induction therapy
- Ecog score 0-3
- Expected survival time greater than 3 months
- 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
- Upper limit of normal value of serum creatinine ≤ 1.5 times
- The upper limit of the normal value of total bilirubin ≤ 1.5 times, except for gilbert's syndrome and leukemia involving organs.
- Upper limit of serum AST,ALT ≤ 3.0 times normal value, except where leukemia involves organs
- The subjects of childbearing age agreed to take effective contraceptives during the treatment and 6 months after the completion of the treatment.
Exclusion
- Diagnosed acute promyelocytic leukemia
- Recent symptomatic central neurosystemic leukemia
- There are grade 2 or more non-hematological toxicity caused by previous chemotherapy
- Bone marrow transplants within 100 days of the study
- Uncontrollable active infections (acute or chronic fungi, bacteria, viruses, or other infections)
- Major surgical treatment of major organs was performed in the first 4 weeks of the study
- Radiotherapy was performed within 4 weeks before entering the study
- 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
- Hiv positive
- Active hepatitis B virus infection (hepatitis B virus surface antigen positive and hepatitis B dna quantity ≥ 1 × 10\^3copies/ml), hepatitis C virus infection or other liver diseases
- Pregnant or lactating women
- There are serious diseases or complications, or diseases that the researchers determine may endanger the safety of the patient or interfere with the study
- Patients who are not considered to be able to enter the study
- Treatment is currently under way in another clinical trial or in another clinical trial within four weeks of the commencement of SKLB1028 treatment
- Patients who have previously received sklb1028 or other FLT3 inhibitors (midostaurin,gilteritinib, quizartinib)
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04015024
Start Date
July 1 2019
End Date
June 1 2021
Last Update
July 16 2019
Active Locations (1)
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1
West China Hospital，Sichuan University
Chengdu, Sichuan, China