acute myeloid leukemia
Conditions
Interventions
Treatment group:1.azacytidine (75mg/m2/day, days 1 to 7). 2.cytarabine (75mg/m2 bid, days 1 to 5). 3.aclamycin (10mg/m2/day, day1,3,5). 4.Chidamide (30mg/day , days 0,3). 5.venetoclax (100mg day 1, 20
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are able to understand and willing to sign the informed consent form (ICF); 2. All patients should be aged 14 to 75 years, no gender limitation; 3. Patients who are diagnosed with R/R AML. Patients who have relapsed from prior remission or Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation; 4. The score of Eastern Cooperative Oncology Group (ECOG) is 0-3, and the predicted survival >= 4 months; 5. Patients without a severe allergic constitution.
Exclusion criteria
Exclusion criteria: 1. Patients with allergy or contraindication to the study drug; 2. Female patients who are pregnant or breast-feeding; 3. Patients with active infection; 4. Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; 5. Patients with mental illness or other states unable to comply with the protocol; 6. Less than 6 weeks after surgical operation of important organs; 7. Liver function: ALT and AST>2.5 times the upper limit of normal , bilirubin>2 times the upper limit of normal; Renal function: creatinine >the upper limit of normal; 8. The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission (CR) Rate;CR with Incomplete Blood Count Recovery Rate (CRi);partial remission rate;Rate of Minimal Residual Disease (MRD);Progression Free Survival (PFS);Overall Survival (OS);Rate of Participants With Adverse Events Type;Safety Assessments; | — |
Countries
China
Contacts
Public ContactLiping Dou
Chinese PLA General Hospital
Outcome results
None listed