Last updated: March 12, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting
Phase
N/A
Condition
Acute Myeloid Leukemia
Platelet Disorders
Leukemia
Treatment
Cytarabine(standard-dose:d1-d7100mg/m2/day)
Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2)
Mitoxantrone hydrochloride liposome injection24mg/m2
Clinical Study ID
NCT05941585
HE071-032
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Able to understand the study and voluntarily sign informed consent.
- Age: 18~65 (including 18) years old, gender unlimited.
- Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to theWorld Health Organization classification of myeloid neoplasms and acute leukemia" whohaven't been treated.
- Eastern Cooperative Oncology Group (ECOG) physical state score: 0-1.
- Fit for intensive chemotherapy.
- The function of main organs should meet the following standards before treatment: Kidney: Serum creatinine ≤ 1.5 × Upper limit of normal range (ULN) Liver: Totalbilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3× ULN
- Patients should agree to use contraception (such as intrauterine device [IUD],contraceptive pill or condom) during the study period and within 6 months after theend of the study; Female patients must have a negative serum pregnancy test within 7days before enrollment.
Exclusion
Exclusion Criteria:
- Any of the following cases:(1) diagnosed as acute promyelocytic leukemia (APL);(2)chronic myelogenous leukemia in blast crisis;(3) AML with central nervous systemleukemia.
- AML arising from prior cytotoxic chemotherapy or radiotherapy for other tumours.
- Patient has been previously diagnosed with another malignancy in last 5 years (exceptfor cured basal cell carcinoma of skin or cervical carcinoma in situ).
- Has been previously treated with doxorubicin or other anthracyclines and drugs forAML.
- Allergic history of mitoxantrone hydrochloride injection or any other drugs used inthis study.
- Those on systemic anti-infective therapy with poorly controlled infection (signs ofinfection progression within 1 week prior to the first dose, or as determined by theinvestigator).
- Patient who is suffering from severe hemorrhagic diseases, such as haemophilia A,haemophilia B, von Willebrand disease and any other spontaneous bleeding requiremedical treatment.
- The estimated survival time is less than 3 months.
- Any of the following conditions occurs in cardiac function:(1) Long QTc syndrome orQTc interval > 480 ms;(2) Complete left bundle branch block or severe atrioventricularblock disease (without a pacemaker);(3) Serious and uncontrolled arrhythmias andunstable angina pectoris requiring drug treatment;(4) History of chronic congestiveheart failure, New York Heart Association (NYHA)≥grade 3;(5) The cardiac ejectionfraction is less than 50% in Echocardiography;(6)Uncontrollable hypertension (definedas multiple measurements of systolic blood pressure > 150 mmHg or diastolic bloodpressure > 90 mmHg under drug control);(7) History of myocardial infarction, unstableangina pectoris, viral myocarditis or severe pericardial disease, ECG evidence ofacute ischemia or active conduction system abnormalities within 6 months before firstdose.
- Patients have thromboembolic events within 6 months prior to first dose, such ascerebrovascular accidents (including transient ischemic attack) and pulmonaryembolism.
- HBsAg/HBcAb positive with HBV-DNA higher than the lower limit of the detection valueof the research center , hepatitis C antibody-positive with HCV-RNA higher than thelower limit of the detection value of the research center, or HIV antibody positive inthe preliminary screening.
- Patients who have been treated with strong/moderate CYP3A inducers/inhibitors or P-gpinhibitors within 7 days prior to first dose (for treatment group 3 only).
- Patients who cannot take oral medications or have absorption disorder (for treatmentgroup 3 only).
- Patient is suffering from any serious and /or non-controllable disease, or theinvestigator determines that the disease might affect the participation of patients inthe study, including (but not limited to, uncontrolled diabetes, dialysis relatedkidney diseases, severe liver diseases, life-threatening autoimmune diseases andhemorrhagic diseases, drug abuse, neurological diseases, etc.).
- Pregnant or lactating female.
- Patients who are not suitable for this study as decided by the investigator due toother reasons.
Study Design
Total Participants: 90
Treatment Group(s): 10
Primary Treatment: Cytarabine(standard-dose:d1-d7100mg/m2/day)
Phase:
Study Start date:
August 08, 2023
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
ChinaActive - Recruiting
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