Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma (RIGOLETTO)
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|ClinicalTrials.gov Identifier: NCT04933942|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2021
Last Update Posted : June 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|First Progression of MGMT Promoter-methylated Glioblastoma||Drug: Lomustine Drug: Romiplostim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study|
|Estimated Study Start Date :||December 2021|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Control group
Oral administration of Lomustine
Experimental: Experimental group
Lomustine plus Romiplostim
Oral administration of Lomustine
Subcutaneous administration of Romiplostim
- Progression Free Survival (PFS) [ Time Frame: 5 months after the last patient in ]
- Overall Survival (OS) [ Time Frame: 5 months after the last patient in ]
- the Health-related Quality of Life (HRQoL) [ Time Frame: 5 months after the last patient in ]HRQoL will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3.
- Frequency of worst Adverse Events (AEs) [ Time Frame: 5 months after the last patient in ]This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933942
|Principal Investigator:||Emilie Le Rhun||EORTC Study Coordinator|