Maintenance Venetoclax in AML Fit Patients

Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07244367

Enrollment

Registered

2025-11-24

Start date

2025-09-01

Completion date

2027-09-01

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukaemia (AML)

Keywords

AML, Venetoclax

Brief summary

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.

Detailed description

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

Interventions

DRUGSC cytarabine +Venetoclax

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

this study is a prospective,phase III , randomized ,open , interventional study. double blind, placebo control clinical trial . Evaluating efficacy of maintenance venetoclax based therapy in Acute meyloid leukemia fit patients who acheived complete remission after standard induction and consolidation therapy.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disease free survival DFS	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

Countries

Egypt

Contacts

Primary ContactEman I Abdelshakour, Asst lect

Eman011065@med.sohag.edu.eg+201063901450

Backup ContactWalaa G Mohamed, Lecturer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026