Medium-dose cytarabine plus venetoclax for consolidation in older adults with intermediate- or high-risk AML

A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination With Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in The Elderly

This study will try giving medium-dose cytarabine together with venetoclax as consolidation therapy to people aged 60–75 with intermediate- or high-risk AML who are in remission after induction.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06990321 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, single-arm phase 3 cohort enrolling about 68 elderly patients with intermediate- or high-risk non-APL AML who are in remission after induction therapy. Participants will receive intermediate-dose cytarabine combined with venetoclax as consolidation between June 1, 2025 and December 31, 2026, with baseline demographics, medications, laboratory results, and outcomes recorded. The study will collect safety and effectiveness outcome measures and perform statistical analyses comparing response durability and relapse rates over the follow-up period. Eligibility includes age 60–75, ECOG 0–2, adequate organ function, and unsuitability for allogeneic stem cell transplantation.

Who should consider this trial

Good fit: Adults aged 60–75 with intermediate- or high-risk non-APL AML who achieved remission after induction, have ECOG 0–2 and adequate labs, and are not suitable for allogeneic transplant are ideal candidates.

Not a fit: Patients with acute promyelocytic leukemia, severe organ dysfunction, those younger than 60 or older than 75, or those who are eligible for transplant are unlikely to be eligible or to benefit from this regimen.

Why it matters

Potential benefit: If successful, this regimen could prolong remission and lower relapse risk for older AML patients who are not candidates for stem cell transplant.

How similar studies have performed: Venetoclax combinations (for example with hypomethylating agents or low-dose cytarabine) have shown benefit in older AML, but using intermediate-dose cytarabine specifically as consolidation is relatively novel and has limited published data.

Eligibility criteria

Inclusion Criteria:

1.Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment):

1. Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
2. AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
3. Serum creatinine \< 2 times the upper limit of normal for the same age group;
4. Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications.

Exclusion Criteria:

Subjects who meet any of the following criteria shall not be included in this study:

1. Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.
2. Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
3. Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
4. Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
5. Known or suspected drug abuse or alcohol dependence.
6. Mental illness or any condition that prevents obtaining informed consent, or inability to comply with the study treatment and examination requirements.
7. Liver dysfunction (total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN, or liver-involved patients with ALT/AST \>5×ULN), kidney dysfunction (serum creatinine \>1.5×ULN).
8. Active heart disease, defined as one or more of the following:

1\) History of uncontrolled or symptomatic angina. 2) Myocardial infarction within 6 months prior to enrollment. 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms.

4\) Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2). 5) Ejection fraction below the lower limit of normal. 9.Participation in another clinical trial within 30 days. 10.Active infection. 11.The investigator deems the subject unfit for participation in this trial.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yehui Tan

Conditions Acute Myeloid Leukemia; Elderly