subcutaneous Granulocyte - Colony Stimulating Factor ( on top of optimal standard of care) and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Patients will be receive optimal standard of care and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Anterior Myocardial Infarction

Heart Failure

rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously

rhu G-CSF

optimal standard of care

Myocardial Contrast Echocardiography with sulphur hexafluoride.

Myocardial Contrast Echocardiography

Fondazione Policlinico Universitario Agostino Gemelli

RIGENERA 2.0 Trial

RIGENERA 2.0 (Recupero Dall'Infarto Miocardico Con G-CSF E Nuovi Esempi di Rigenerazione Avanzata) Project: "The Combined Effect of Subcutaneous Granulocyte - Colony Stimulating Factor and Myocardial Contrast Echocardiography With Intravenous Infusion of Sulphur Hexafluoride on Post-infarction Left Ventricular Function"

Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic Resonance and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Clinical Major adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and rehospitalization due to heart failure) at 1 year

Antonio Maria Leone, MD

MD, PhD

Catholic University of the Sacred Heart

Part A: RG7388 as a single agent; given at a starting dose of 100 mg each day for five days for the first cycle which will be 56 days.
Part B: combination of RG7388 and Pegasys if subject does not achieve at least a PR by the end of 3 cycles of single agent RG7388

Polycythemia Vera

Essential Thrombocythemia

RG7388 is supplied as film-coated tablets at dosage strengths of 50 mg, 200 mg, 300mg and 400 mg.

RG7388

PEGASYS is supplied as a clear, sterile solution for subcutaneous (SQ) injection available in prefilled syringes. weekly doses at 45ug subcutaneously

Pegasys

Georgetown University Medical Center

Icahn School of Medicine at Mount Sinai

Wake Forest University Baptist Medical Center

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

Open Label Phase I Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia (With Pilot Feasibility Study in Combination With Pegylated Interferon Alfa 2a for Patients Who do Not Respond to the Single Agent at Each Dose Level)

John Mascarenhas

Associate Professor

Roche Pharma AG

The Leukemia and Lymphoma Society

Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.

Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.

Childhood Choroid Plexus Tumor

Childhood Medulloblastoma

Childhood Pineoblastoma

Childhood Soft Tissue Sarcoma

Childhood Supratentorial Primitive Neuroectodermal Tumor

Neuroblastoma

Osteosarcoma

Retinoblastoma

Wilms Tumor and Other Childhood Kidney Tumors

Recurrent/Refractory Childhood Hodgkin Lymphoma

Unspecified Childhood Solid Tumor, Protocol Specific

Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)

filgrastim

Barbara Ann Karmanos Cancer Institute

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer

The analysis will be reported by displaying mean values (for each treatment in each sequence) as well as their differences, and 95% confidence intervals for the mean difference between treatments (adjusting for the period effect). Kaplan-Meier approach will be used.

Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

GLM procedure will be performed to examine differences between groups.

Univariately, continuously scaled variables will be presented as means, standard deviations, medians, ranges, and interquartile ranges.

febrile neutropenia/baş ağrısı

RIGENERA 2.0 Trial

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

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