A Phase Ib Study of CT053PTSA in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Exclusion Criteria

• •Subject meeting any of the following criteria will be excluded.
• •1. treatment history
• •1. chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;
• •2. nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;
• •3. have taken live vaccines within 4 weeks prior to /or concurrent with the administration;
• •4. received FLT3 or Axl inhibitors within 6 weeks prior to the administration;
• •5. have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration
• •2. disease history and surgery history
• •a) 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) b) with myeloid sarcoma or invasion of central nervous system; c) high blood pressure and not well controlled by drug (blood pressure ≥ 140/90 mmHg). Note: Blood pressure before the first administration (mean blood pressure of two measures that 24 hours interval or above ) should be controlled within 140/90 mmHg.
• •d) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \<50%; e) 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; f) any of the illness bellowed within 12 months prior to administration: myocardial infarction, severe or unstable angina, coronary artery bypass graft or peripheral artery bypass surgery, congestive heart failure, cerebrovascular events (including Transient ischemic attack); g) multiple factors that affect oral medication (eg, can not swallow, chronic diarrhea and intestinal obstruction, etc.); h)obvious tendency of gastrointestinal bleeding, including the following cases: local active ulcer lesion, and fecal occult blood test(≥++); melena or hematemesis within 2 months; gastrointestinal bleeding may occurs considered by investigator.
• •i)history of immunodeficiency, other acquired or congenital immunodeficiency,history of organ transplantation; j) previous thyroid dysfunction,thyroid function can not be maintained at the normal range even have drug taken.
• •k)Human immunodeficiency virus(HIV) positivity l) Hepatitis B surface antigen (HBsAg)positivity, and in the active phase(hepatitis B nucleic acid quantity≥ 1.00 × 103copies / ml); m) Hepatitis C antibody(Anti-HCV) positivity and in the active phase (hepatitis C nucleic acid quantity ≥1.00 × 102copies / ml) n) severe retinopathy or exfoliation judged by the Investigator; o) severe electrolyte imbalance judged by the investigator; p) active infectious disease judged by the investigator; q) other acute or chronic medical or psychological illnesses that are not suitable for clinical trials considered by the investigator or sponsor;
• •3. Pregnant or lactating women or female and male with fertility plan. 4)the therapy and/or drug forbidden
• •1. taking anticoagulant or vitamin K antagonist such as warfarin, heparin or other similar drugs;
• •2. taking other anti-leukemia drugs at the same time, including traditional Chinese medicine (some Chinese medicine can not be used listed in Annex 4);
• •3. taking drugs that will prolong QT interval(including Ia and III antiarrhythmic drugs);
• •4. patients who need oxygen therapy every day;
• •5. long-term use of corticosteroids (local inhalation excluded);
• •5)others
• •a) history of Psychotropic drugs abuse and can not drop or the mentally disordered; b) be used to drink grapefruit juice or too much tea, coffee and / or caffeine-containing drink, can not stop during the trial(including Cycle 1 and subsequent treatment period) c) in the vegistrator's judgment, there is a serious accompany disease that jeopardizes patient's safety or interfere with the completion of the study.
• •\-