A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    80
  • sponsor
    Sunshine Lake Pharma Co., Ltd.
Updated on 10 May 2022
calcium
potassium
serum bilirubin level
refractory acute myeloid leukemia (aml)
acute promyelocytic leukemia

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.

Description

It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.

Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.

Details
Condition Acute Myeloid Leukemia
Treatment Clifutinib Besylate
Clinical Study IdentifierNCT04827069
SponsorSunshine Lake Pharma Co., Ltd.
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented acute myeloid leukemia according to World Health Organization(WHO) criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse
ECOG performance status of 0-1
Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment:
Lood routine examination: WBC≤2000/mm3
Liver function: Alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≤2.5×upper limit of normal(ULN); serum bilirubin ≤ 1.5 × ULN
Renal function: Serum creatinine ≤ 1.5×ULN, or the creatinine clearance (CrCl)≥ 60 mL / min calculated by the Cockcroft-Gault formula
Electrolyte: serum potassium≥3.0mmol/L; serum calcium≥2.0 mmol/L;serum magnesium≥0.5 mmol/L
Coagulation function:fibrinogen≥1.0g/L; activated partial thromboplastin time( APTT)≦ULN+10s; prothrombin time(PT)≤ULN+3s

Exclusion Criteria

Received FLT3 inhibitors within 4 weeks prior to the administration
Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD
Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration
Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration
Have taken live vaccines within 4 weeks prior to /or concurrent with the administration
Have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration
Documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(PML)/retinoic acid receptor alpha (RARa) positivity found in the chromosome, variant acute promyelocytic leukemia
With myeloid sarcoma or invasion of central nervous system
NCI CTCAE 4.03 ≥ 2 grade of arrhythmia, or corrected QT interval(QTc )> 450 ms ; patients with a history of torsion or congenital QT prolonged syndrome; active infectious disease judged by the investigator
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