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Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult

NCT06285136 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-29

No results posted yet for this study

Summary

This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country.

Conditions

  • Acute Myeloid Leukemia, Adult

Interventions

PROCEDURE

DEC3-VEN

Venetoclax in combination with decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time \>2h) Sorafenib 800mg/d, d8-14 (only for FLT3/ITD mutation positive patients)

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Handan Central Hospital

    collaborator OTHER

  • Taian City Central Hospital

    collaborator OTHER

  • Tianjin People's Hospital

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Central South University

    collaborator OTHER

  • Western Theater General Hospital

    collaborator UNKNOWN

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Chengdu Jingdongfang Hospital

    collaborator UNKNOWN

  • The Second Affiliated Hospital of Kunming Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06285136 on ClinicalTrials.gov