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Brief Title: Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma
Official Title: Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study
Study ID: NCT04933942
Brief Summary: Romiplostim for low platelets caused by lomustine chemotherapy in patients with first recurrence (growing back) of a brain tumor, glioblastoma that is MGMT methylated. Lomustine is an anticancer drug often used to treat glioblastoma that grows back after initial treatment. This anticancer drug can cause side effects. The most frequent and potentially serious side effect of all is lowering of the blood platelets. Low platelets can cause bleedings in the the stomach and intestines, the skin, the brain and other systems and tissues. Low platelets are also the main cause of delaying or prematurely (ending treatment before the planned end) stopping chemotherapy. There is no treatment for low platelets except platelet transfusions. Romiplostim is a drug that stimulates the production of platelets in the bone marrow. It is an approved drug in USA, Europe, Australia and Switzerland for a special type of blood disease in which the body breaks down its own blood platelets. The purpose of the study is to start the treatment with romiplostim once low platelets are diagnosed in order to restore the platelet count and to prevent the platelet count from dropping again during the lomustine treatment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Clinic Universitari de Barcelona, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
UniversitaetsSpital, Zürich, , Switzerland
Name: Emilie Le Rhun
Affiliation: EORTC Study Coordinator
Role: PRINCIPAL_INVESTIGATOR