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Safety and Efficacy of Venetoclax in Combination With Azacitidine and HA Regimen in the Treatment of AML in the Elderly

NCT05949762 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-07-18

No results posted yet for this study

Summary

This is a prospective phase II, single-arm clinical study that plans to enroll 45 patients aged 60 years or older with primary AML diagnosed after April 1, 2023.The purpose of this trial is to evaluate the efficacy of Venetoclax in combination with azacitidine and HA regimens in elderly patients aged \>60 years with primary acute myeloid leukemia and to provide evidence for optimal selection of clinical treatment regimens.

Conditions

Interventions

PROCEDURE

Venetoclax in Combination With Azacitidine and HA Regimen

Patients diagnosed with primary AML based on morphology, immunophenotyping, and history and meeting the inclusion exclusion criteria were induced with Venetoclax in combination with Azacitidine and HA regimen. Details for: Venetoclax 200mg d1-10 Azacitidine 100mg/d (or 50-75mg/m2/d), d2-7 Hautriacontin 2mg/m2/d, d3-7 Cytarabine 100mg/m2/d, d3-8 (infusion 24h)

Sponsors & Collaborators

  • Handan Central Hospital

    collaborator OTHER

  • Taian City Central Hospital

    collaborator OTHER

  • Tianjin People's Hospital

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    collaborator OTHER

  • Western War Zone General Hospital

    collaborator UNKNOWN

  • ZePing Zhou

    lead OTHER

Principal Investigators

  • ZePing Zhou · The Second Affiliated Hospital of Kunming Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05949762 on ClinicalTrials.gov