Maintenance therapy with Venetoclax for elderly patients with acute myeloid leukemia in remission

Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

This study is testing if a medication called Venetoclax can help older patients with acute myeloid leukemia stay in remission and live longer after their initial treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05909293 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of maintenance therapy using BCL-2 inhibitors, specifically Venetoclax, in elderly patients aged 60 to 85 who have achieved their first complete remission from acute myeloid leukemia (AML). The study is a prospective, multicenter, open-label, single-arm design, focusing on patients who have undergone induction and consolidation treatments. By administering Venetoclax, the study aims to observe potential survival benefits and safety profiles in this patient population, building on previous findings regarding maintenance therapies for elderly AML patients.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60 to 85 who have achieved first complete remission from acute myeloid leukemia after induction and consolidation therapy.

Not a fit: Patients with acute promyelocytic leukemia or those who have not achieved complete remission may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new maintenance therapy option that improves survival rates for elderly patients with AML.

How similar studies have performed: Previous studies have shown promising results with maintenance therapies for elderly AML patients, indicating a potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with acute myeloid leukemia (AML) diagnosed based on bone marrow morphology and immunophenotyping (meeting the diagnostic criteria of WHO 2016).
* Achieving first complete remission (CR) or incomplete complete remission (CRi) after 1-2 cycles of induction therapy and receiving consolidation treatment for at least 4 cycles.
* Age between 60 and 85 years.
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN), serum bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 2.0 times ULN, and serum creatine kinase \< 2.0 times ULN.
* Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Obtaining informed consent from the patient or their legal representative.

Exclusion Criteria:

* Acute promyelocytic leukemia, myeloid sarcoma, blast phase of chronic myeloid leukemia.
* Patients who achieve CR after relapse and re-induction therapy.
* Extramedullary involvement of AML, including active central nervous system leukemia.
* Allergy to any of the drugs involved in the protocol. Pregnant or lactating women and reproductive-age patients who are unwilling to use contraception.
* Significant abnormalities in liver or kidney function beyond the inclusion criteria.
* Presence of organic heart disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction with clinical symptoms or cardiac dysfunction within the past 6 months (according to New York Heart Association functional classification NYHA ≥ 3).
* Concurrent presence of other malignant tumors, except for the following conditions:

  1. Patients who have received curative-intent treatment and have not had any known active disease of malignant tumors for ≥ 5 years before enrollment.
  2. Patients who have received adequate treatment and do not show signs of disease for non-melanoma skin cancer or malignant melanocytic nevi (even if it is within 3 years before randomization).
  3. Patients who have received adequate treatment and do not show signs of disease for in situ carcinoma (even if it is within 3 years before randomization).
* Patients with HIV/AIDS, syphilis, active hepatitis B (detectable HBV-DNA), and hepatitis C.
* Any concurrent medical condition or disease (such as active systemic infection) that may interfere with the study procedures or results or pose risks to the participant as determined by the investigator.Inability to understand or comply with the study protocol.
* Patients younger than 60 years or older than 85 years.
* Undergoing major surgery within 4 weeks prior to randomization.
* Patients who have undergone allogeneic hematopoietic stem cell transplantation.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ming Hong, MD

Conditions Acute Myeloid Leukemia