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Venetoclax-Decitabine in Untreated Elderly/Unfit AML

ConditionAML, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe Second Hospital of Hebei Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients meeting the World Health Organization (WHO) 2022 diagnostic criteria for acute myeloid leukemia (AML), excluding:Acute promyelocytic leukemia (APL)

Patients classified as AML, not otherwise specified (NOS) per WHO criteria, excluding:Acute panmyelosis with myelofibrosis 、Myeloid sarcoma

No prior AML therapy, except:Hydroxyurea、Low-dose cytarabine (<1.0 g/day)

ECOG performance status ≤3

Disqualifiers

AML with BCR::ABL1 fusion or chronic myeloid leukemia (CML) in blast crisis.

Previously treated AML patients (received prior induction chemotherapy, regardless of response).

Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)

Concurrent hematologic disorders (e.g., hemophilia, myelofibrosis, or other conditions deemed ineligible by the investigator). Exception: Patients with prior blood count abnormalities but confirmed non-MDS/MPN by bone marrow examination may be included.

Trial design

Design model

Single group

Treatments tested in this trial

  • VEN + DEC

    Drug

    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

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: VEN+DECExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the Complete Remission (CR) Rate after Cycle 1

Time frame
up to 42 days after treatment

Secondary outcomes

1

Overall Survival (OS)

Time frame
Within 5 years after randomization
2

Relapse-Free Survival Rate (RFS)

Time frame
Within 5 years after randomization
3

Cumulative incidence of relapse

Time frame
Within 5 years after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Hospital of Hebei Medical University

Lead sponsor

Handan First Hospital

Collaborator

Source ClinicalTrials.gov
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