MPD-RC 112 (Pegasys)

• Research type

  Research Study

• Full title

  Randomized Trial of Pegylated Interferon Alfa-2a versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera and High Risk Essential Thrombocythemia

• IRAS ID

  90880

• Contact name

  Claire Harrison

• Sponsor organisation

  Consorzio Mario Negri Sud

• Eudract number

  2010-019501-41

• Clinicaltrials.gov Identifier

  NCT01259856

• Research summary

  The MPD-RC 112 Pegasys trial is an international, multicentre, not-for-profit, investigator-generated, randomised, phase III trial promoted by the Myeloproliferative Disorders Research Consortium (MPD-RC). The study design is a randomized open label clinical trial between hydroxyurea and Pegylated Interferon Alfa-2a in two independent disease strata: (1) high risk polycythaemia vera (PV) and (2) high risk essential thrombocythaemia (ET). The primary objective is to compare the complete haematologic response rates in patients randomized to treatment with the Pegylated Interferon Alfa-2a (PEGASYS) vs. Hydroxyurea. Patients randomised in this trial will be treated for up to 12 months (with 3 months for confirmation - therefore up to 15 months) to achieve complete or partial response. Patients who achieve a complete or partial response will be followed for up to a maximum of 4 years for the first patient and 2 years for the last patient.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1606

• Date of REC Opinion

  10 Jan 2013

• REC opinion

  Further Information Favourable Opinion