The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.
Name: PegIntron
Name: Pegasys
Name: PegIntron
Name: Pegasys
Name: Hydrea
Description: Molecular responses (JAK V617F allele burden) are assessed by qPCR according to the ELN guidelines.
Measure: molecular response (changes from baseline) Time: 18, 36 and 60 monthsDescription: The proportion of patients treated with PegIntron, Pegasys and Hydrea who need to discontinue therapy due to intolerability
Measure: toxicity (discontinuation of therapy due to intolerability) Time: 18 monthsDescription: Quality of life will be evaluated according to EORTC QLQ C-30 and MPN-SAF
Measure: Quality of life (changes from baseline) Time: 4, 12, 24, 36, 48 and 60 monthsDescription: A bone marrow sample will be evaluated in order to detect and grade changes in bone marrow morphology.
Measure: Histopathological response (changes from baseline) Time: 36 and 60 monthsDescription: investigation of the sustainability of an obtained molecular remission (< 1% JAK2V617F mutated alleles) after discontinuation of interferon- alpha( Pegasys, PegIntron, Multiferon) or Hydrea.
Measure: Sustained molecular response (changes from level at time of discontinuation of therapy) Time: 12, 24 and 36 monthsDescription: Proportion of patients treated with Peintron and Pegasys who have developed neutralizing antibodies.
Measure: Neutralizing antibodies against PegIntron and Pegasys Time: 24 monthsDescription: Hematological response will be evaluated according to the ELN guidelines.
Measure: hematological response Time: 12 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Molecular responses (JAK V617F allele burden) are assessed by qPCR according to the ELN guidelines.. toxicity (discontinuation of therapy due to intolerability). --- V617F ---
In 2005 major breakthrough in our understanding of the molecular pathophysiology was achieved with the identification of the JAK2 V617F mutation which is present in almost all patients with PV (98%) and about half of patients with ET and PMF. --- V617F ---
Within recent years IFN-alpha has demonstrated a capacity of inducing deep molecular remission (evaluated by JAK2 V617F qPCR) and normalisation of bone marrow morphology. --- V617F ---
If patients have a sustained deep molecular response (below 1 % JAK2 V617F mutated alleles for 12 months) therapy will be stopped to asses the sustainability of the remission off therapy.Patients over the age of 75 and intolerant or resistant to hydroxyurea will be offered rescue treatment with orally busulfan (Myleran). --- V617F ---