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

PHASE3CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
High Risk Polycythemia VeraHigh 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.

Trial Locations (25)

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

Weill Cornell Medical College, New York

11632

Ospedale San Maartino Genova, Genova

17822

Geisinger Cancer Center, Danville

20007

Georgetown University Medical Center, Washington D.C.

27100

San Matteo Hospital, Pavia

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

30322

Emory Hospital, Atlanta

60612

John H. Stroger Hospital of Cook County, Chicago

University of Illinois at Chicago, Chicago

66205

University of Kansas Cancer Center, Westwood

75010

Hopitaux de Paris, Paris

84132

University of Utah, Salt Lake City

85259

Mayo Clinic, Scottsdale

90033

USC Norris Comprehensive Cancer Center, Los Angeles

94301

The Palo Alto Clinic, Palo Alto

94305

Stanford University School of Medicine, Stanford

Unknown

Ospedale Riuniti de Bergamo, Bergamo

University Of Florence, Florence

00168

Universita Cattolica del Sacro Cuore, Rome

BT9 7AB

Belfast City Hospital, Belfast

B9 5SS

Heart of England NHS Foundation Trust, Birmingham

SE1 7EH

Guy's and St. Thomas' NHS Foundation Trust, London

All Listed Sponsors
collaborator

Myeloproliferative Disorders-Research Consortium

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Roche Pharma AG

INDUSTRY

lead

Ronald Hoffman

OTHER

NCT01259856 - Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) | Biotech Hunter | Biotech Hunter