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

  • STATUS
    Recruiting
  • End date
    Mar 18, 2023
  • participants needed
    30
  • sponsor
    LanZhou University
Updated on 9 May 2022
remission
cytarabine
idarubicin
azacitidine
cladribine
venetoclax

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.

Description

Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.

regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.

Details
Condition Acute Myeloid Leukemia
Treatment cytarabine, Idarubicin, Azacitidine, cladribine, venetoclax
Clinical Study IdentifierNCT05053425
SponsorLanZhou University
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The elderly patients(≥ 60) with AML diagnosed according to WHO criteria
Participants are ineligible for induction regimen
The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3
The patients and their families agree and sign the informed consent form

Exclusion Criteria

Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs)
Infiltration of the central nervous system
Drugs use history affecting CYP3A within 7 days before enrollment
participants considered by the investigator to be unsuitable for inclusion
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