MedDRA version: 14.1 Level: LLT Classification code 10043559 Term: Thrombocytopenia toxic System Organ Class: 100000004851 MedDRA version: 14.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nplate 250 micrograms powder for solution for injection
Product Name: Nplate 250 micrograms powder for solution for injection
Pharmaceutical Form: Powder for solution for injection
Sponsors
CHRU de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the incidence of completed chemotherapy cycles;Secondary Objective: • To evaluate the safety of Romiplostim in treating Chemotherapy Induced Thrombocytopenia (CIT) in newly diagnosed glioblastoma patients receiving myelosuppressive chemotherapy by Temozolomide (TMZ). • To determine the incidence of delayed chemotherapy cycles and the incidence of chemotherapy cycles with dose reduction due to severe TP. • To describe the incidence of TP resolution during Romiplostim treatment period. • To determine the incidence of platelets transfusion for TP during Romiplostim treatment. • To describe the adverse events during Romiplostim and Temozolomide combined treatment. • To determine the 6 months Progression Free Survival. ;Primary end point(s): Proportion of patients receiving 100% of the planned TMZ dosage in the whole Stupp protocol. The primary endpoint will consider dose reduction and dose delay.;Timepoint(s) of evaluation of this end point: 34 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of serious adverse events according to CTCAE 4.0 criteria. • Incidence of chemotherapy cycles with dose reduction and reasons for dose reduction, incidence of postponed cycles of chemotherapy, reasons for delay and number of delayed days. • Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim. • Number and percentage of patients receiving platelets transfusion for TP. • Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment. • 6 months Progression Free Survival: The progression will be defined according to the RANO criteria. The progression will not be reported as an adverse event if it is related to the disease. ;Timepoint(s) of evaluation of this end point: 34 weeks | — |
Countries
France
Contacts
Public ContactY. MORICE
CHRU de Lille
Outcome results
None listed