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Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma | Clinical Trials | Clareo Health

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

Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study

NCT04933942•European Organisation for Research and Treatment of Cancer - EORTC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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 for first-line treatment
•Patients may have been operated for recurrence. If operated, patients should have fully recovered from surgery as assessed by the investigator. Criteria for full recovery include absence of post-operative infection, recovery from medical complications (CTCAE grade 0 and 1 acceptable). Residual and measurable disease after surgery is not required, but surgery must have confirmed the recurrence. The post-surgery MRI (performed within 72 h) can be used for enrolment if dated within 6 weeks of enrolment.
•For non-operated patients: recurrent disease must correspond to at least one bi-dimensionally measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with minimal diameters of 10 mm (10x10 mm), visible on 2 or more axial slices 5 mm apart (measurable disease according to RANO criteria). The MRI can be used for enrolment if dated within 6 weeks prior to enrolment.
•In case of clinical deterioration or increase of steroids since the last MRI, a new MRI should be done prior to enrolment and should be dated within 6 weeks prior to enrolment.
•Patients diagnosed with a venous thromboembolism or thrombotic events within the last 3 months can be enrolled if they have been on a stable regimen of anticoagulants for at least 14 days.
•Capacity for adequate fluid and oral intake
•Adequate bone marrow (except for platelet count, which can be \<100 x 109/L at enrolment), renal and hepatic function within 7 days before enrolment
•Hemoglobin ≥ 8 g/dl
•Leukocytes count NOT requiring CGSF per local Standard of Care
+29 more criteria

Locations (5)

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

Zurich, Switzerland

Key Dates

Start Date

September 13, 2022

Primary Completion Date

December 19, 2022

Completion Date

December 19, 2022

Last Updated

May 24, 2023

Conditions

First Progression of MGMT Promoter-methylated Glioblastoma

Interventions

Lomustine

DRUG

Romiplostim

DRUG