GLOW: JNJ-54179060 - CLL3011
Research type
Research Study
Full title
A randomised, open-label, phase 3 study of the combination of ibrutinib plus venetoclax versus chlorambucil plus obinutuzumab for the first-line treatment of subjects with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL).
IRAS ID
242258
Contact name
Tahla Munir
Contact email
Eudract number
2017-004699-77
Duration of Study in the UK
5 years, 10 months, 30 days
Research summary
This is a research study in 200 patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). These are both types of cancer that create abnormal white blood cells, and both are treated in the same way.
The type and intensity of initial therapy for patients is guided by multiple factors, with patients falling into either a “fit” or “less fit” category. This study will only involve “less fit” patients. Standard care initial therapy for these patients is 6 months treatment with two medications: chlorambucil plus obinutuzumab (known as “G-Clb”).
In this study, half of the patients will receive standard care treatment. This will be compared to an investigational, fixed duration combination of medications that half of the patients will receive: ibrutinib plus venetoclax (known as “I+VEN”). These medications are currently approved for use individually for the treatment of CLL/SLL, but are not approved when used together.
The purpose of the study is to see whether CLL/SLL responds to treatment with ibrutinib plus venetoclax, and to compare the efficacy and safety of the investigational combination with standard care. I+VEN was chosen as the medications work well together and previous studies have indicated that the combination may result in better patient outcomes.
The study is conducted in 3 phases: screening (up to 30 days), treatment (between 6 – 18 months), and follow-up (every 6 months). Participation in the study will last up to 6 years. Half the participants will receive 6 months treatment with G-Clb (6 cycles of 28 days), and half the patients will receive 18 months of treatment with I+VEN (18 cycles of 28 days, with the first and last 3 cycles of treatment with ibrutinib only).
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0069
Date of REC Opinion
20 Mar 2018
REC opinion
Favourable Opinion