D45
Conditions
Interventions
Group 1: The treatment duration with IFN is planned for two years. Treatment with is performed continuously without interruptions.
Therapy starts with 50 µg PegIntron/week (dose level 1) (subcutaneo
Sponsors
III. Medizinische Universitätsklinik
Universitätsmedizin Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnosis PV according to the WHO criteria, age 18 years or older without upper age limit, no cytoreductive pretreatment or pretreatment with at most one cytoreductive drug, persistent need of phlebotomies during previous therapy no preteatment with non-pegylated interferon alpha, written informed consent.
Exclusion criteria
Exclusion criteria: Cytoreductive pretreatment with more than one drug, pretreatment with non-pegylated interferon alpha postpolycythemic myelofibrosis, splenectomy, secondary malignancy, if requiring therapy severe comorbidity, pregnancy and breast feeding, diseases of CNS psychiatric disorders, paticipation in an other cliniocal study, no consent of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the antiproliferative effects of PegIntron on the main parameters of the increased myeloproliferation (frequency of phlebotomies, platelet count, spleen size) after two years of therapy. These effects will be assessed using the response criteria outlined in the summary of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of side effects and rate of termination of therapy due to non-acceptable toxicity insufficient response or intolerance. | — |
Countries
Germany
Contacts
Public ContactEva Lengfelder
III. Medizinische Universitätsklinik Universitätsmedizin Mannheim
Outcome results
None listed