Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)

Summary

This research is looking 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.

The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. The study subject will be followed for their condition for about 5 years. The subject will be randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat subjects with ET or PV currently, but the investigators are unsure which study drug is better.

Conditions

• High Risk Polycythemia Vera
• High Risk Essential Thrombocythemia

Interventions

DRUG

PEGASYS

The subject will begin receiving the PEGASYS at a dose level of 45 micrograms weekly and gradually get increased to the maximum dose of 180 micrograms per week. The dose will be administered by prefilled syringes that will be injected subcutaneously. Subjects will receive therapy for up to 12 months.

DRUG

Hydroxyurea

Subjects will receive a 500mg tablet to be taken twice daily for up to 12 months of treatment.

DRUG

Aspirin

Subject will be asked to take 81 to 100mg per day for the 12 months of the study treatment.

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

• Ronald Hoffman, MD · Icahn School of Medicine at Mount Sinai

• Claire Harrison, MD · Guy's and St Thomas' NHS Foundation Trust

• Ruben Mesa, MD · Mayo Clinic

• Jean-Jacques Kiladjian, MD · Hopitaux de Paris

• Mary Frances McMullin, MD · Belfast Health and Social Care Trust

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

Study Design

Allocation

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

2017-06-30

Completion

2017-06-30

Countries

• United States
• France
• Italy
• United Kingdom

Study Locations