CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

Phase 2

Not yet recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: CHG Combined With Venetoclax and Azacytidine

• Registration Number: NCT06470841
• Lead Sponsor: Navy General Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Study Start: 2024-09-20
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHG Combined With Venetoclax and Azacytidine	CHG Combined With Venetoclax and Azacytidine	Patients were treated by CHG Combined With Venetoclax and Azacytidine

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1 year	ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China