M19-388 Venetoclax Extension Study
Research type
Research Study
Full title
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
IRAS ID
281051
Contact name
David Lewis
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2018-004356-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Blood cancers like Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin’s lymphoma (NHL), and Acute Lymphoblastic Leukemia (ALL) are grouped under the umbrella of hematologic (blood) malignancies (cancers). The purpose of this extension study is to provide Venetoclax to and see how safe it is for participants who continue to tolerate and obtain benefit from receiving the drug in ongoing studies.
Venetoclax is an oral drug developed for the treatment of various blood cancers. It kills cancer cells by blocking a protein (part of a cell) that allows cancer to stay alive. Participants in this study will continue to receive Venetoclax at the same dose administered to them during the previous study in which they were enrolled. If patients are receiving other drugs at the time of study entry, they may continue to receive them, but the other drugs will not be supplied or reimbursed. Adult participants with diagnosis of CLL, AML, MM, NHL, and ALL participating in ongoing Venetoclax studies will be enrolled. Around 550 participants will be enrolled in the study in approximately 323 sites worldwide.
Participants will receive oral Venetoclax daily and will be evaluated per standard of care. Participants should return every 12 weeks (± 2 weeks) to continue receiving Venetoclax and will be monitored for adverse events (side effects) and use of concomitant (associated) medicines. Participants will receive Venetoclax daily until discontinued from the study.
There will be 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 the treatment will be checked by medical assessments, blood and urine tests, checking for side effects and completing questionnaires.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0161
Date of REC Opinion
20 Jul 2020
REC opinion
Further Information Favourable Opinion