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RECRUITING
NCT05805098
PHASE2/PHASE3

Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Official title: Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-03-01

Completion Date

2028-03-01

Last Updated

2023-04-07

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.

DRUG

Homoharringtonine

On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.

DRUG

Cytarabine

On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Locations (1)

Qiu Huiying

Suzhou, Jiangsu, China