RIGOLETTO (EORTC 1926-BTG)
Research type
Research Study
Full title
Romiplostim for thrombocytopenia induced by lomustine at first progression of MGMT promoter-methylated glioblastoma: a randomized phase II open label multicenter study.
IRAS ID
1005011
Contact name
Eliza Starczewska
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer EORTC
Eudract number
2020-005429-10
Clinicaltrials.gov Identifier
Research summary
This study is for adults with a type of brain cancer called MGMT promoter-methylated glioblastoma, who have recently been diagnosed with low platelets in their blood, caused by their chemotherapy treatment (called lomustine). Low platelets are a common and potentially serious side effect of chemotherapy. We want to understand more about treating low platelet levels by using a treatment called romiplostim which is already approved for use in the USA, Europe, Australia and Switzerland to treat a type of blood disease in which the body breaks down its own platelets.
In this study, we want to find out whether giving romiplostim can help platelet levels go back to normal and stop the level from dropping again during further chemotherapy treatment. We want to find out if giving romiplostim will allow people to continue having chemotherapy without low platelets, compared with standard of care. We also want to find out if giving romiplostim means that there are fewer delays or stoppages to chemotherapy and fewer changes to the chemotherapy dose than with standard of care, which means that there is better control of this type of brain cancer.
In this study the benefit is measured by the length of time it takes before the disease worsens (also called progression-free survival). We will also look at the safety of the treatment and the effect on participants’ health and quality of life.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0442
Date of REC Opinion
28 Jul 2022
REC opinion
Further Information Favourable Opinion