Acute Myeloid Leukemia
Conditions
Brief summary
The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.
Detailed description
The investigators will evaluate response rate of CHG regimen Combined With Venetoclax in newly diagnosed acute myeloid leukemia. After induction therapy, patients will be given standardized treatment according to risk stratification according to NCCN guidelines. Progression free survival (PFS), Overall survival (OS), and Toxicity will be counted.
Interventions
DRUGCHG Combined With Venetoclax and Azacytidine
Patients were treated by CHG Combined With Venetoclax and Azacytidine: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7; Homoharringtonine 1mg/m2 iv qd d1-14; Cytarabine 10mg/m2 subcutaneous injection q12h d1-14; G 250ug/m2 subcutaneous injection qd d0-14.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements. * The patient is willing and able to adhere to the study visit schedule and other protocol requirements. * The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO). * The patient should not have received any prior treatment for AML.
Exclusion criteria
* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 1 year | ORR was defined as the proportion of patients who achieved CR or PR as their best response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | through study completion, an average of 3 years | OS was defined as time from diagnosis to death from any cause or the last follow-up |
| Progression Free Survival (PFS) | 2 years | For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse. |
Countries
China
Contacts
Primary ContactLiren Qian, PhD
Outcome results
None listed