A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients
Study Details
Study Description
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 With FLT3 Mutations.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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 myeloid leukemia with FLT3 mutation. Divided into three dose groups,150mg BID,200mg BID,300mg QD. The main end point is total remission rate (ORR), total survival time (OS), progress-free survival time (PFS), remission duration, FLT3 suppression rate, competitive parameters, safety (incidence of adverse events).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: SKLB1028 150mg bid Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs. |
Drug: SKLB1028 150mg bid
150mg oral administration twice a day
|
Experimental: SKLB1028 200mg bid Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs |
Drug: SKLB1028 200mg bid
200mg oral administration twice a day
|
Experimental: SKLB1028 300mg qd Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs |
Drug: SKLB1028 300mg qd
300mg oral administration once a day
|
Outcome Measures
Primary Outcome Measures
- Total remission rate (ORR) [Evaluation at the end of each cycle(a cycle is 28 days) of administration and at the end of the study (assessed up to approximately 24 months)]
Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission(PR)
Secondary Outcome Measures
- Progression-free survival time (PFS) [Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death]
- Total survival time (OS) [30 days after last subject discontinues treatment (assessed up to approximately 24 months)]
- CR mitigation duration (DoR-CR) [Time from the date at which the patient's objective status is first noted to be a CR to the earliest date progression is documented (assessed up to approximately 24 months]
- FLT3 inhibition rate [Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)]
- Incidence of adverse events [From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)]
- Vital signs [From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)]
- 12-lead ECG [From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)]
- physical examination [From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)]
- laboratory examination [From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Volunteer and sign informed consent forms
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Male or female Chinese patients, age ≥ 18 years old
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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
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Ecog score 0-3
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Expected survival time greater than 3 months
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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
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Upper limit of normal value of serum creatinine ≤ 1.5 times
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The upper limit of the normal value of total bilirubin ≤ 1.5 times, except for gilbert's syndrome and leukemia involving organs.
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Upper limit of serum AST,ALT ≤ 3.0 times normal value, except where leukemia involves organs
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The subjects of childbearing age agreed to take effective contraceptives during the treatment and 6 months after the completion of the treatment.
Exclusion Criteria:
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Diagnosed acute promyelocytic leukemia
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Recent symptomatic central neurosystemic leukemia
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There are grade 2 or more non-hematological toxicity caused by previous chemotherapy
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Bone marrow transplants within 100 days of the study
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Uncontrollable active infections (acute or chronic fungi, bacteria, viruses, or other infections)
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Major surgical treatment of major organs was performed in the first 4 weeks of the study
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Radiotherapy was performed within 4 weeks before entering the study
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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
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Hiv positive
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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
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Pregnant or lactating women
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There are serious diseases or complications, or diseases that the researchers determine may endanger the safety of the patient or interfere with the study
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Patients who are not considered to be able to enter the study
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Treatment is currently under way in another clinical trial or in another clinical trial within four weeks of the commencement of SKLB1028 treatment
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Patients who have previously received sklb1028 or other FLT3 inhibitors (midostaurin,gilteritinib, quizartinib)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | West China Hospital,Sichuan University | Chengdu | Sichuan | China |
Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1028201901/PRO