Clinical Trial Details
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NCT02227576 : Prevention of Thrombocytopenia in Glioblastoma Patients
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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).

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.
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