A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients

Acute Myeloid Leukemia Clinical Trial

Official title:

Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04015024
• Other study ID #: 1028201901/PRO
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Volunteer and sign informed consent forms

2. Male or female Chinese patients, age = 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: a) met any of the following conditions. B) 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:

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 × 10^3copies/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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrence

Intervention

Drug:
• SKLB1028 150mg bid
150mg oral administration twice a day
• SKLB1028 200mg bid
200mg oral administration twice a day
• SKLB1028 300mg qd
300mg oral administration once a day

Locations

Country	Name	City	State
China	West China Hospital,Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total remission rate (ORR)	Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission(PR)	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)
Secondary	Progression-free survival time (PFS)		Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Secondary	Total survival time (OS)		30 days after last subject discontinues treatment (assessed up to approximately 24 months)
Secondary	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
Secondary	FLT3 inhibition rate		Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)
Secondary	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)
Secondary	Vital signs		From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Secondary	12-lead ECG		From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Secondary	physical examination		From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Secondary	laboratory examination		From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)