SECONDARY PROPHYLAXIS USE OF ROMIPLOSTIM FOR THE PREVENTION OF THROMBOCYTOPENIA IN NEWLY DIAGNOSED GLIOBLASTOMA PATIENTS - PLATUM

CHRU de Lille0 个研究点目标入组 35 人开始时间: 2013年12月6日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•Histological proof of newly diagnosed glioblastoma,
•Age: 18 and older,
•Information to patient and signed consent form,
•Indication for a « Stupp » protocol (cerebral focal radiotherapy and concomitant TMZ followed by adjuvant TMZ – 6 cycles),
•Patient with grade 3 or 4 TP during Temozolomide chemotherapy, regardless of when the onset of TP was: after completion of concomitant RT/CT, before adjuvant CT or during adjuvant CT and only if a minimum of 2 cycles are still planned,
•Normal initial platelets count (> 100 000/mm3) before the start of Temozolomide during the RT/CT concomitant phase,
•Adequate haematological, renal, hepatic function at the time of inclusion visit,
•ECOG PS 0-2 (patients unable to walk because of a paralysis and who are up in a wheel chair will be considered as ambulatory for the evaluation of the ECOG performance status),
•Life expectancy > 2 months,
•Patients covered by the French Health Insurance System,
•Negative pregnancy test at the time of inclusion visit,
•If required, effective contraception respecting criteria of CPMP/ICH/286/95 (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•Concomitant radiotherapy (Romiplostim will be started after the completion of the RT/CT concomitant phase),
•Other malignancies (prior hx malignancies),
•Any anterior systemic chemotherapy,
•Any known coagulation disease or known haematological disease even if resolved. Known hypercoagulate state (e.g., factor V Leiden, protein C defiency, protein S deficiency, PT 20201, antiphospholipid antibody syndrome…),
•Prior Romiplostim exposure or prior exposure to other TPO mimetics,
•History of thromboembolic disease < 6 months. Treatment with anticoagulant such as Heparin or antivitamin K (LMWH as prophylactic treatment is authorized),
•Any other hemato-toxicity (anemia, neutropenia) requiring EPO or GCSF,
•Other causes of Temozolomide interruption (non haematological toxicities),
•Known hypersensitivity to any E-coli derived product,
•Participation to any other study during the last 30 days,
•Refusal to give written informed consent,
•Pregnancy or nursing,
•For all men and women of childbearing potential: Refusal or inability to use effective means of contraception,
•Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
•Persons protected by a legal regime (guardianship, trusteeship),
•Patients in emergency situations,
•Patients kept in detention.

发起方

CHRU de Lille