Venetoclax and Azacitidine after Stem Cell Transplant in AML (VIALE-T)
Research type
Research Study
Full title
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)
IRAS ID
276686
Contact name
Liz Sheasby
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2019-002621-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 17 days
Research summary
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (white blood cells responsible for fighting infections). Successful treatment of AML depends on what sub-type of AML the patient has, and the age of the patient when diagnosed. This study will evaluate the safety and efficacy of Venetoclax and Azacitidine compared to Best Supportive Care (BSC) in patients with AML, following allogeneic stem cell transplant.
Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study will include approximately 424 total adolescent and adult participants with AML post-transplant in Part 1 and Part 2 of the trial, in 17 countries. Adolescent participants will only be enrolled in Part 2. Approximately 24 participants will be enrolled in Part 1 of the study.
The study consists of two parts: In Part 1, the safety and dosing of Venetoclax and Azacitidine will be established. Part 2 of the study will focus on efficacy of Venetoclax and Azacitidine, as compared to BSC, after stem cell transplant. The total length of the study will depend on enrollment of participants, with a current estimate of about 7 years.
During visits, various examinations like physical exam, blood tests, bone marrow samples, questionnaires, and vital signs will be conducted.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0160
Date of REC Opinion
10 Jun 2020
REC opinion
Further Information Favourable Opinion