Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

Inclusion Criteria: * Age 18 years or more on day of signing informed consent * Karnofsky Performance Score (KPS) of 60-100 * Life expectancy \> 8 weeks * Stable or decreasing dose of steroids for at least 1 week prior to enrolment * Glioblastoma isocitrate dehydrogenase (IDH1) R132H wild-type, per cIMPACT NOW recommendations (Brat et al., 2018; Brat et al., 2020) * MGMT promoter methylation determined by methylation-specific PCR or pyrosequencing or methylation profiling per local assessment. * Treatment with lomustine alone for first progression after any treatment comprising intent to treat with standard TMZ /RT →TMZ for newly diagnosed glioblastoma, with at least one dose of maintenance TMZ received. Hypofractionated regimens of RT are allowed. Patients should have received at least 75% of the RT dose. Patients enrolled in a clinical study for newly diagnosed glioblastoma and treated with standard of care and an experimental agent can participate. Patients who had RT alone or TMZ alone for newly diagnosed glioblastoma are not eligible. Patients must have received at least one dose of lomustine * Clinically relevant thrombocytopenia defined as thrombocytopenia requiring dose delay of lomustine for at least one week (more than 7 days) (for any grade of toxicity) or requiring a dose reduction of lomustine because of grade 3 or 4 thrombocytopenia * Diagnosis of first progression according to RANO criteria (Wen et al., 2010) more than 3 months after the end of radiotherapy fo…