Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

NCT05053425 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-26

No results posted yet for this study

Summary

In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.

Conditions

Interventions

DRUG

Venetoclax

given po.

DRUG

Azacitidine

given sc.

DRUG

Cladribine

given ivgtt.

DRUG

Cytarabine

given sc or ivgtt.

DRUG

Idarubicin

given ivgtt.

Sponsors & Collaborators

  • LanZhou University

    lead OTHER

Principal Investigators

  • Long Zhao, M.M. · The First Hospital of Lanzhou University,Lanzhou,Gansu,China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2023-01-18
Completion
2023-03-18

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05053425 on ClinicalTrials.gov