Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04933942
Status:
WITHDRAWN
Last Update Posted:
2023-05-24
First Post:
2021-06-14
Brief Title:
Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma a Randomized Phase II Open Label Multicenter Study
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Amgen withdrew interest in providing further financial support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIGOLETTO
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None