Treatment of relapsed / refractory acute myeloid leukemia (AML)
Conditions
Interventions
experimental group:Oral tablet
specification: 10mg
once a day, 10mg each time
duration of administration: one day for a single administration
14 days for continuous administration, one treatment cycle every 21 days, until disease progression or intolerability.
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects fully understand the purpose, content, process and possible adverse reactions of the test, voluntarily act as the subjects and sign the informed consent; 2. It was diagnosed as relapsed / refractory acute myeloid leukemia (AML); 3. Aged >= 18 years, male or female; 4. After hematology support treatment, the ECoG physical strength score was 0-2; 5. The estimated survival time is at least 12 weeks; 6. The subjects had proper organ function, which was in accordance with the results of laboratory examination before admission; 7. Previous treatment before administration of investigational drug; 8. The subjects were willing to provide effective diagnosis evidence before treatment or to accept bone marrow puncture or biopsy for diagnosis, and were willing to accept bone marrow puncture or biopsy for efficacy evaluation after treatment; 9. The subjects agreed that there was no birth plan or sperm / egg donation plan within 3 months after the last administration, and they voluntarily took effective physical contraceptive measures; 10. Observe the regulations of lifestyle precautions during the test; 11. The subjects were able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergy to acc010 tablet or any drug component, or have had two or more drugs and / or food allergies; 2. There are other serious diseases that may hinder the understanding of the research, the compliance of the research treatment, the safety or the interpretation of the research results; 3. Urine drug abuse screening is positive or has drug abuse history or used drugs in the past 3 years; 4. Positive breath test or alcohol history; 5. Participated in clinical trials of other drugs within one month before administration of the test drug; 6. Take excessive special diet or vigorous exercise within 7 days before administration of the test drug, or other factors affecting acc010 absorption, distribution, metabolism, excretion, etc.; 7. Any food or drink containing alcohol or caffeine, such as chocolate or coffee, has been ingested within 24 hours before administration of the test drug; 8. Female subjects were in pregnancy or lactation, or the quantitative results of serum ß- hCG exceeded the upper limit of normal range; 9. The researchers believe that subjects have other factors that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity (DLT) and maximum tolerable dose (MTD).;The safety was evaluated by adverse events, body weight, BMI, ECoG score, vital signs, physical examination, urine routine, stool routine and occult blood, blood biochemistry, coagulation function, urine pregnancy test, 12 lead ECG, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indexes: Cmax, Tmax, auc0-t, aucinf, MRT, T1 / 2, Cl, VD, Cmax, SS, Cmin, SS, CAV, SS, auc0-t, SS, aucinf, SS, auc0 - t, SS, AR, DF, etc.;Objective response rate, compound response rate, complete response rate, cytogenetic response rate, molecular biology response rate, response duration, event free survival time, recurrence free survival time, total survival time; | — |
Countries
China
Contacts
Public ContactJie Jin
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed