relapsed/refractory acute myeloid leukemia, or intermediate- and high-risk myelodysplastic syndromes
Conditions
Interventions
50mg?100mg?200mg?300mg?450 mg and 600 mg Dose group:CTS2016
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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. Male or female patient aged >=18 years; 3. Diagnosis of relapsed/refractory acute myeloid leukemia (AML); 4. Diagnosis of relapsed/refractory intermediate- and high-risk myelodysplastic syndromes (MDS); 5. Eastern Cooperative Oncology Group (ECOG) performance status of = 12 weeks at screening; 7. Subjects should take adequate non-drug contraceptive measures from the time of signing the informed consent to 180 days after the last administration.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL positive chronic myeloid leukemia(b-cell acute lymphoblastic leukemia); (2) Patients with MDS have uncorrected serum folic acid deficiency or vitamin B12 deficiency, as well as treatment-related MDS (t-MDS), myeloproliferative disease (MPN) transformed MDS; (3) Patients with other malignant tumors, except for the following cases: cured stage IB or lower-grade cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete response (CR)>10 years, and other malignant tumors with complete response (CR)>5 years; (4) Non-hematologic toxicity above grade 2 caused by previous treatment for AML or MDS; (5) Hematopoietic stem cell transplantation (HSCT) within 2 months before the first administration, or the continuous non-hematological toxicity related to transplantation >= 2, or the graft-versus-host disease requiring treatment; (6) Patients with Central nervous system (CNS) involvement; (7) Having received cytotoxic chemotherapy drugs within 2 weeks or within 5 half-lives (whichever is longer), or non-cytotoxic chemotherapy drugs within 5 half-lives (excluding hydroxyurea and other treatments used to control leukocytosis), or adoptive immunocyte therapy, including chimeric antigen receptor T cells (CAR-T cells), within 12 weeks before the first administration; (8) Liver function: ALT > 2.5*ULN, and AST > 2.5*ULN; total bilirubin (TBIL) >1.5*ULN; Renal function: blood creatinine >1.5*ULN or eGFR = 45%); (13) ECG examination in screening period showed that QTcF> 450 ms in male, QTcF> 470 ms in female or in patients with long QT syndrome; (14) Present with active or uncontrolled infection; positive for hepatitis B virus surface antigen (HBsAg) or positive for hepatitis B core antibody and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) >= 2000 IU/mL within nearly 3 months; Positive for hepatitis C antibody (HCV-Ab) and hepatitis C virus (HCV) ribonucleic acid (RNA) within nearly 3 months; known active syphilis infection or human immunodeficiency virus (HIV); (15)Female patients in pregnancy or lactation; (16)Patients with known gastrointestinal absorption abnormalities or swallowing problem; (17)Patients who are not suitable to participate in this clinical study due to any clinical or laboratory examination abnormalities or other reasons judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE Rate;Dose-limiting toxicity;the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2Ds); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Objective remission rate;duration of remission, DoR;Event-free survival;Relapse-free survival;Overall survival OS; | — |
Countries
China
Contacts
Public ContactXudong Wei
Henan Cancer Hospital
Outcome results
None listed