Clinical Trials /

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

NCT04015024

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients
  • Official Title: Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients

Clinical Trial IDs

  • ORG STUDY ID: 1028201901/PRO
  • NCT ID: NCT04015024

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
SKLB1028 150mg bidSKLB1028 150mg bid
SKLB1028 200mg bidSKLB1028 200mg bid
SKLB1028 300mg qdSKLB1028 300mg qd

Purpose

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.

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).
    

Trial Arms

NameTypeDescriptionInterventions
SKLB1028 150mg bidExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs.
  • SKLB1028 150mg bid
SKLB1028 200mg bidExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
  • SKLB1028 200mg bid
SKLB1028 300mg qdExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
  • SKLB1028 300mg qd

Eligibility Criteria

        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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Total remission rate (ORR)
Time Frame: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)
Safety Issue:
Description:Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission(PR)

Secondary Outcome Measures

Measure:Progression-free survival time (PFS)
Time Frame:Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Safety Issue:
Description:
Measure:Total survival time (OS)
Time Frame:30 days after last subject discontinues treatment (assessed up to approximately 24 months)
Safety Issue:
Description:
Measure:CR mitigation duration (DoR-CR)
Time Frame: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
Safety Issue:
Description:
Measure:FLT3 inhibition rate
Time Frame:Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)
Safety Issue:
Description:
Measure:Incidence of adverse events
Time Frame:From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Safety Issue:
Description:
Measure:Vital signs
Time Frame:From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Safety Issue:
Description:
Measure:12-lead ECG
Time Frame:From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Safety Issue:
Description:
Measure:physical examination
Time Frame:From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Safety Issue:
Description:
Measure:laboratory examination
Time Frame:From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Trial Keywords

  • Acute myeloid leukemia
  • monotherapy
  • SKLB1028

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