M16-186 Phase 1 study of Venetoclax and Alvocidib in R/R AML Patients
Research type
Research Study
Full title
Phase 1b Study of Venetoclax and Alvocidib in Patients with Relapsed/Refractory Acute Myeloid Leukemia
IRAS ID
238375
Contact name
Natalia Tomkiewicz
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-002531-42
Duration of Study in the UK
1 years, 6 months, 24 days
Research summary
Acute Myeloid Leukaemia (AML) is a cancer of the white blood cells. Myeloid cells are a type of white blood cell 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.
A small number of AML patients respond to current medications but most patients with AML will relapse (their cancer will return) or will not respond to treatment and have poor survival rates.
Venetoclax is an experimental drug that kills cancer cells. Alvocidib is an experimental drug that stops the spread of fast growing cancer cells. Both drugs have been studied in patients with AML and each has activity against the disease. The goal of this study is to see if the combination of both drugs works even better in patients who have relapsed or do not respond to treatment.
In this study, all patients will receive both drugs. For Alvocidib, all patients will receive the drug daily for the first 3 days of each treatment period (cycle) only. For venetoclax, all patients will receive increasing doses for the first 3 or 4 days initially, followed by a fixed daily dose for the rest of the 28 day cycles. After the 1st cycle, patients will continue to have study visits and receive treatment as long as they tolerate it and show clinical benefit. The study will take place at about 15 sites and enrol approximately 44 patients.
The effect of the treatment on AML will be checked by taking blood, bone marrow, and measuring side effects. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.REC name
Wales REC 1
REC reference
18/WA/0243
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion