Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET)

Summary

The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots.

It is important for patients with ET or PV who are at risk of blood clots to receive drugs which will minimize the risks of developing these blood clots but at the moment the investigators are not sure which drugs will best control the disorder.

The purpose of this study is to look at the effectiveness of giving patients who have been diagnosed with ET and PV a study drug regimen using Aspirin and PEGASYS (also known as Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea (or hydroxycarbamide or Hydroxyurea), for whom this drug may not be suitable. The drug may not be suitable either because it is not adequately controlling the number of blood cells or some specific side effects occur.

Conditions

• High Risk Polycythemia Vera
• High Risk Essential Thrombocythemia

Interventions

DRUG

PEGASYS

Patient will start at 45 micrograms per week and gradually increase to 180 micrograms per week. Pegasys will be supplied in prefilled syringes and are to be given subcutaneously.

DRUG

Aspirin

81 or 100 mg daily.

Sponsors & Collaborators

• Myeloproliferative Disorders-Research Consortium

  collaborator NETWORK

• National Cancer Institute (NCI)

  collaborator NIH

• Roche Pharma AG

  collaborator INDUSTRY

• Ronald Hoffman

  lead OTHER

Principal Investigators

• John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

• Ellen Ritchie, MD · Myeloproliferative Disorders-Research Consortium

• Alessandro Rambaldi, MD · Myeloproliferative Disorders-Research Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• United States
• Italy

Study Locations