CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

NCT06470841 | Not Yet Recruiting Phase 2

• 1 other identifier: WATCH2023
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the proportion of patients who achieved CR or PR as their best response

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  through study completion, an average of 3 years

• Progression Free Survival (PFS)

  2 years

Study Arms (1)

CHG Combined With Venetoclax and Azacytidine

EXPERIMENTAL

Patients were treated by CHG Combined With Venetoclax and Azacytidine

Drug: CHG Combined With Venetoclax and Azacytidine

Interventions

CHG Combined With Venetoclax and Azacytidine DRUG

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.

Also known as: VACHG

CHG Combined With Venetoclax and Azacytidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Liren Qian, PhD

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947192; qlr2007@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)