RecruitingNot ApplicableNCT07117422

Venetoclax-Decitabine in Untreated Elderly/Unfit AML

Efficacy and Safety of Venetoclax Plus Decitabine in Elderly/Unfit Patients With Newly Diagnosed AML: A Multicenter Single-Arm Study

Sponsor

The Second Hospital of Hebei Medical University

Enrollment

39 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

AML, Adult

Summary

Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use. Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — venetoclax and decitabine — in older or physically frail adults who have been newly diagnosed with acute myeloid leukemia (AML), a cancer of the blood. The goal is to find a gentler but effective treatment for people who cannot tolerate standard intensive chemotherapy. **You may be eligible if...** - You are 65 or older and prefer not to receive intensive chemotherapy, OR you are over 18 and have been found unfit for standard chemotherapy due to heart, lung, or kidney issues - You have a new diagnosis of AML (specific subtypes only) - You have not received prior AML treatment (except hydroxyurea or low-dose cytarabine) - Your liver and kidney function are within acceptable ranges - You are willing to use contraception during and for 3 years after treatment **You may NOT be eligible if...** - You have a specific AML subtype called APL, or AML with BCR-ABL fusion - Your AML developed from a prior blood disorder (MDS or MPN) or from prior cancer treatment - You have active HIV, hepatitis B or C, or untreated tuberculosis - You have had a heart attack in the last 6 months or have uncontrolled heart failure - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVEN + DEC

Induction regimen Venetoclax (VEN): Day1-10 Decitabine (DEC):20mg/m²/day, Day 2-4 20mg/m² every 8 hours, Day 5-6 FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14 Post-Remission Treatment Venetoclax (VEN): 400 mg/day, Day 1-7 Decitabine (DEC): 20 mg/m² every 8 hours, Day 2-3 (Regimen repeated every 4-6 weeks) FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14