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Trial Title:
CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML
NCT ID:
NCT06470841
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CHG Combined With Venetoclax and Azacytidine
Description:
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.
Arm group label:
CHG Combined With Venetoclax and Azacytidine
Other name:
VACHG
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Navy General Hospital
Address:
City:
Beijing
Zip:
100048
Country:
China
Contact:
Last name:
Liren Qian, M.D.
Phone:
+861066957676
Email:
qlr2007@126.com
Start date:
September 20, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06470841
