Maintenance Venetoclax in AML Fit Patients

this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.

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Key information

Conditions

Acute Myeloid Leukaemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university, Sohag, Egypt

About this study

this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age : 18 - 60 years . Patients who are not eligible for immediate bone marrow transplantation. Newly diagnosed AML patients who attained CR after 1st line. Refractory / recurrant AML patients who attained CR after 2nd line .

Exclusion criteria

Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation

Treatment and study plan

SC cytarabine +Venetoclax

Drug

SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation

Other names: Venclexta

Primary outcomes

Disease free survival DFS

Time frame: 24 months

time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Eman I Abdelshakour, Asst lect

CONTACT

[email protected]

+201063901450 ext. +201122103385

Walaa G Mohamed, Lecturer

CONTACT

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Nov 24, 2025
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting