Maintenance Venetoclax in AML Fit Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SC cytarabine +Venetoclax.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukaemia (AML). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
Overview
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
- Drug SC 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
Primary outcome measures
- Disease free survival DFS [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Sohag university hospital — Sohag
- Sohag university — Sohag
Publications
- 1. Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374:2209-21. 2. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. Lancet. 2023;401:2073-86. 3. Miranda-Filho A, Piñeros M, Ferlay J, et al: Epidemiological patterns of leukaemia in 184 countries: A population-based
Identifiers
NCT: NCT07244367 · Soh-Med-25-9---3MD