A randomized, open label, multicentre trial to define the most effective haemoglobin concentration to start erythropoietin beta (neoRecormon) therapy in anaemic subjects with lymphoproliferative malignancy receiving chemotherapy
*REPOS Study*

Evidence is growing that the use of erythropoietin in patients treated with
chemotherapy for solid (and haematological) malignancies may have positive
effects on the number of red cell units that have to be transfused and the
quality of life. However, until now the vast majority of studied patients were
anaemic (Hb generally < 6.8 mmol/l) at the start of erythropoietin
administration. It is therefore unknown at which blood haemoglobin
concentration administration of erythropoietin should be started, in order to
achieve optimal increase in Hb and reduction of red blood cell transfusions;
already at the low-normal Hb level (Hb 7.2 mmol/l), or near the level of
indication for red blood cell transfusion (6.2 mmol/l).
Preventing a Hb-decline by starting erythropoietin treatment in the range above
the ASCO/ASH guidelines for the use of erythropoietin, i.e. above 6.2 mmol/l
[60], may lead to a better effect in patients suffering chemotherapy-induced
anaemia.
This study will assess a comparison of the clinical outcomes following early
initiation of NeoRecormon® 30 000 IU once a week (Hb < 7.2 mmol/l) versus late
initiation (Hb < 6.2 mmol/l) in adult, anaemic patients with
lymphoproliferative malignancy and the overall safety of NeoRecormon® 30 000 IU
once a week.

To compare the efficacy of erythropoietin beta administered weekly using an
early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb *
6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving
chemotherapy during a 16-week treatment phase, , ,measured by an increase in
haemoglobin * 1.2 moll/l or a haemoglobin concentration * 7.4 mmol/l (without
red blood cell transfusion).

Open label, randomized, multi centre trial

To compare the efficacy of erythropoietin beta administered weekly using an
early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb *
6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving
chemotherapy during a 16-week treatment phase, measured by an increase in
haemoglobin * 1.2 moll/l or a haemoglobin concentration * 7.4 mmol/l (without
red blood cell transfusion).

The treatment phase with erythropoietin beta is 16 weeks. During this period
patient will visit the outpatient clinic every 4 weeks at the same time
chemotherapy is administrated.
Normal routine blood samples will betaken. Quality of Life questionnaires will
be filed out 3 times during this period
The benefit of treatment with NeoRecormon is improvement of quality of life
during the period of chemotherapy.
Adverse events of NeoRecormon such as hypertension and trombosis are rare and
always reversible.
Adverse events of red blood cell transfusion are eg allergic reactions, anti
body formation and transmission of infections (eg HIV and hepatitis) could be
irreversible.