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Acute Myeloid LeukemiaPhase 2NCT04015024

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

A Phase 2 study testing SKLB1028 150mg bid, SKLB1028 200mg bid and SKLB1028 300mg qd in people with Acute Myeloid Leukemia, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
SKLB1028 150mg bid, SKLB1028 200mg bid and SKLB1028 300mg qd
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jul 2019to Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Ting Liu, Dr., 86-028-85422364, liuting@scu.edu.cn

Other trials in China

About this study

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

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.

Read the 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).

Being tested
SKLB1028 150mg bid, SKLB1028 200mg bid, SKLB1028 300mg qd
Keywords
Acute myeloid leukemia, monotherapy, SKLB1028
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKLB1028 150mg bidDrug

    150mg oral administration twice a day

  • SKLB1028 200mg bidDrug

    200mg oral administration twice a day

  • SKLB1028 300mg qdDrug

    300mg oral administration once a day

Study groups in NCT04015024
Study groupRoleWhat they receive
SKLB1028 150mg bidExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs.
Receives: Drug: SKLB1028 150mg bid
SKLB1028 200mg bidExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Receives: Drug: SKLB1028 200mg bid
SKLB1028 300mg qdExperimentalRepeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Receives: Drug: SKLB1028 300mg qd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total remission rate (ORR)

    Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission（PR）

    Measured: 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 outcomes (9)

  1. Progression-free survival time (PFS)

    Measured: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death

  2. Total survival time (OS)

    Measured: 30 days after last subject discontinues treatment (assessed up to approximately 24 months)

  3. CR mitigation duration (DoR-CR)

    Measured: 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

  4. FLT3 inhibition rate

    Measured: Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)

  5. Incidence of adverse events

    Measured: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

  6. Vital signs

    Measured: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

  7. 12-lead ECG

    Measured: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

  8. physical examination

    Measured: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

  9. laboratory examination

    Measured: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study startJul 2019 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
The dose was initiated at 150 mg bid and after completion of the safety tolerance,200 mg bid was performed.300mg qd is safe and tolerant at phase 1 ,so the other participants were able to conduct the 300 mg qd test group when the safety tolerance.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04015024
Sponsor's protocol ID
1028201901/PRO
Status last verified
Jul 2019
First submitted
22 May 2019
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKLB1028 150mg bid, SKLB1028 200mg bid and SKLB1028 300mg qd in people with Acute Myeloid Leukemia, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04015024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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