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

NCT05909293 | Recruiting

• 1 other identifier: 2022-SR-541
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 2-year overall survival (OS)

  2-year overall survival (OS) refers to the percentage of patients who are alive 2 years after a certain event or treatment.The time from diagnosis to patient death or the end of follow-up is calculated.

  From the time of CR/CRi to time for up to 2 years

• Recurrence-free survival (RFS)

  The term "Recurrence-free survival (RFS)" refers to the period of time starting from the point of complete remission (CR) or incomplete complete remission (CRi) and ending at the occurrence of leukemia relapse or any event leading to death. During this period, the patient does not experience a relapse or progression of leukemia and does not die from other causes. RFS is an important measure of survival used to assess the effectiveness of treatment in controlling leukemia relapse.

  From the time of CR/CRi to time for up to 2 years

Secondary Outcomes (3)

• Assessment of efficacy.

  At the end of the 6 cycle of treatment, which corresponds to 28 days per cycle.

• The impact of maintenance therapy on minimal residual disease (MRD) kinetics.

  From the time of CR/CRi to time for up to 2 years

• Safety evaluation

  From the time of CR/CRi to time for up to 2 years

Study Arms (1)

Venclexta

EXPERIMENTAL

During the consolidation phase, which occurs within 2 months after the completion of consolidation therapy, the BCL-2 inhibitor maintenance treatment will consist of 12 cycles, with each cycle lasting 28 days. The specific regimen for the Venclexta is as follows: Venclexta: 400mg/day, orally, from day 1 to day 14 of each cycle.

Drug: Venclexta 100 MG Oral Tablet

Interventions

Venclexta 100 MG Oral Tablet DRUG

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.

Also known as: Granulocyte colony-stimulating factor (G-CSF), Interleukin-11 (IL-11), Antibiotics, Blood products, Antiemetics

Venclexta

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• Patients who have received curative-intent treatment and have not had any known active disease of malignant tumors for ≥ 5 years before enrollment.
• 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).
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Huai'an First People's Hospital: collaborator
• Yancheng First People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Tablets; Granulocyte Colony-Stimulating Factor; Interleukin-11; Anti-Bacterial Agents; Antiemetics

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Agents; Gastrointestinal Agents

Central Study Contacts

Ming Hong, MD

CONTACT

+8613914722662; minniehm122@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 18, 2023
• Study Start: April 12, 2023
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (1)