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 receivin chemotherapyREPOSstudy - Repos study

• Conditions: Anemia in cancer patients

• Registration Number: EUCTR2006-003727-37-NL
• Lead Sponsor: Haga Teaching Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

? patients with lymphoproliferative malignancy i.e. Multiple Myeloma (MM), Chronic Lymphocytic Leukaemia (CLL), Non Hodgkin Lymphoma (NHL) and Hodgkin’s Lymphoma (HL).
? chemotherapy induced anaemia with a Hb concentration within the range 6.2–7.2 mmol/l within 2 weeks prior to randomisation.
? at least 12 additional; weeks of cytotoxic chemotherapy planned, regardless of schedule.
? age >18 years.
? life expectancy > 6 months.
? if systemic anticancer therapy is to be given, it should be scheduled for at least 12 weeks from the time of first study treatment. Patients who are currently receiving systemic anticancer therapy will be eligible.
? written informed consent before any study-specific procedure, including screening procedures, was done.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Transfusion of red blood cells during the 2 weeks immediately prior to randomization.
? rHuEPO treatment within 12 weeks before inclusion.
? Known (documented) primary haematological disorder that could cause anaemia, other than a lymphoproliferative malignancy (e.g. sickle cell anaemia).
? Clinically significant active flammatory disease, as determined by principal investigator (e.g. rheumatoid arthritis, Chron’s disease).
? Performance status = 3 according to the ECOG scale:
? iron deficiency (transferrine saturation < 15 % and serum ferritine < 10 ng/ml);
? vitamin B12 deficiency, (< lower normal limit);
? folic acid deficiency (S- folate < lower normal limit);
? haemolysis: haptoglobin ( S- haptoglobin < lower normal limit);
? inadequate renal or liver function (S-Creatinine 2x ULN and /or transaminases > 5x ULN)
? history of significant neurological or psychiatric disorders including psychotic
disorders or dementia;
? documented unstable or uncontrolled disease or condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure (New York Heart Association Class > II, uncontrolled hypertension (diastolic heart pressure > 100 mmHg) and or cardiac arrhythmia) ;
? known history of allergy to any of the study medications or their excipients.
? females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment. Male and female patients with reproductive potential must use an approved contraceptive method (e.g. intrauterine device (IUD), birth control pills or barrier device) during the study and for 3 months after the study.
? any unregistered drug in the 30 days preceding the first dose of the study medication or during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified