Main info

Identificatie:

HOVON 61 NHL

Sponsor:

HOVON

Active sites:

6

(of 6)

Title:

Supportive care in chemotherapy-related anemia in elderly non-Hodgkin's lymphoma: Darbepoetin alfa (Ara-nesp) versus red blood cell transfusion.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Registration in the HOVON 46 NHL trial;
• Hb levels <= 6.2 mmol/l (<= 10 g/dl);
• Completion of baseline quality of life questionnaire;
• Written informed consent

Exclusion Criteria:

• Hypersensitivity to components of darbepoetin;
• Treatment with epoetin or epoetin-related drugs within 4 weeks before registration in the HOVON 46 NHL trial;
• Red cell transfusion after registration in the HOVON 46 NHL trial and within 4 weeks before randomization;
• Correctable anemia not related to chemotherapy or bone-marrow infiltration such as deficiencies (iron, vit. B12, folic acid, autoimmune hemolysis);
• Anemia due to other hematological diseases such as myelodysplastic syndromes or myeloproliferative syndromes;
• Uncontrolled hypertension.

Participating Sites

= Active hospitals

= Inactive hospitals