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CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

N

Navy General Hospital, Beijing

Status and phase

Not yet enrolling
Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: CHG Combined With Venetoclax and Azacytidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06470841
WATCH2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

85 participants in 1 patient group

CHG Combined With Venetoclax and Azacytidine
Experimental group
Description:
Patients were treated by CHG Combined With Venetoclax and Azacytidine
Treatment:
Drug: CHG Combined With Venetoclax and Azacytidine

Trial contacts and locations

1

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Central trial contact

Liren Qian, PhD

Data sourced from clinicaltrials.gov

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