RecruitingPhase 2Phase 3NCT05805098

Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

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


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

60 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of three drugs — venetoclax, homoharringtonine, and cytarabine — as initial (induction) treatment for younger adults newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer. **You may be eligible if:** - You are between 18 and 60 years old - You have been newly diagnosed with AML (confirmed by WHO criteria) - You have not previously been treated for AML - You are eligible for and able to tolerate intensive chemotherapy - Your heart, kidneys, and liver are functioning adequately - Your white blood cell count can be brought below a safe threshold before treatment starts **You may NOT be eligible if:** - You are over 60 or under 18 years old - You have acute promyelocytic leukemia (a specific subtype, called M3) - You are ineligible for intensive chemotherapy due to severe health problems - Your organ function is too poor for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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.

DRUGHomoharringtonine

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

DRUGCytarabine

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


Locations(1)

Qiu Huiying

Suzhou, Jiangsu, China

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NCT05805098


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