Status:
COMPLETED
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed 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 Be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04827069
Start Date
May 18 2018
End Date
August 30 2023
Last Update
September 19 2024
Active Locations (1)
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1
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China