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

NCT05909293 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Huai'an First People's Hospital

    collaborator OTHER

  • Yancheng First People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2025-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909293 on ClinicalTrials.gov