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RECRUITING

NCT05909293

Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission. This study involves the following content: BCL-2 inhibitors.

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

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-04-12

Completion Date

2028-05-30

Last Updated

2023-06-18

Healthy Volunteers

Conditions

Acute Myeloid Leukemia

Interventions

DRUG

Venclexta 100 MG Oral Tablet

When there is a deficiency of neutrophils, G-CSF treatment may be necessary. The treatment is continued until the absolute neutrophil count (ANC) reaches either \>0.5×109/L and remains at that level for 3 consecutive days, or \>2×109/L. The purpose of G-CSF therapy in this context is to stimulate the production of neutrophils and restore their levels to a sufficient and stable range. This helps to strengthen the immune system and reduce the risk of infections associated with low neutrophil counts. When experiencing Grade 3-4 thrombocytopenia, subcutaneous injection of IL-11 can be administered as a treatment. When symptoms of infection occur, aggressive antimicrobial therapy and other supportive treatments should be administered. All blood products should undergo irradiation when transfused, and all blood products must be filtered before infusion. If gastrointestinal adverse reactions occur, antiemetic medications can be administered to alleviate symptoms.

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China