M19-708 Venetoclax as Maintenance Therapy for AML
Research type
Research Study
Full title
Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
IRAS ID
275346
Contact name
Richard Dillon
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2019-002217-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 30 days
Research summary
Acute Myeloid Leukemia (AML) is cancer of the White Blood Cells (WBC). Myeloid cells are a type of WBCs which perform many functions, including fighting bacterial infections and defending the body against parasites. Acute means it progresses rapidly and aggressively, which means AML requires immediate treatment. The purpose of this study is to evaluate the safety and efficacy of Venetoclax with azacitidine (AZA) compared to Best Supportive Care (BSC) as maintenance therapy in participants with Acute Myeloid Leukemia (AML) in first remission after conventional chemotherapy.
Venetoclax is an oral drug developed for treatment of AML. It kills cancer cells by blocking a protein (part of a cell) that allows cancer to stay alive. The study has two arms: Part 1 (dose confirmation), and Part 2 (randomization). Part 2 consists of 2 study arms – Arm A wherein Venetoclax and AZA will be given along with BSC, and Arm B, wherein BSC will be given. Adult participants with diagnosis of AML will be enrolled. Part 1 will enrol 20 participants and Part 2 will enrol 340 participants. The study will be conducted in approximately 175 sites across 19 countries.
Participants in Part 1 and Part 2 Arm A will receive oral Venetoclax once daily for 28 days and intravenous (IV) or subcutaneous (SQ) AZA daily for the first 5 days of each 28-day cycle for the first 6 cycles only. Study treatment may be received for up to 2 years and participation in this study may last up to 5 years.
There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.
REC name
Wales REC 1
REC reference
20/WA/0098
Date of REC Opinion
29 Apr 2020
REC opinion
Further Information Favourable Opinion