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
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
-
given po.
- DRUG
-
given sc.
- DRUG
-
Cladribine
given ivgtt.
- DRUG
-
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
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