Chemotherapy induced anemia MedDRA version: 7.0 Level: PT Classification code 10049105
Conditions
Interventions
Trade Name: Aranesp
Product Name: Darbepoetin alfa 500 µg/mL syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Other descriptive name: 500 µg/mL syringe
Concent
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - non-myeloid malignancy (Chronic Myeloid Leukemia [CML], acute leukemia [AML & ALL], Hairy Cell Leukemia, Burkitt’s Lymphoma and lymphoblastic lymphoma are specifically excluded) - planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening). - hemoglobin concentration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (eg, sickle cell anemia, thalassemia) - radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - unstable or uncontrolled disease/condition, related to or affecting cardiac function (eg, unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - chronic inflammatory disease that is not stable (eg, rheumatoid arthritis, Crohn’s disease, peptic ulcer, ulcerative disease, etc) - active bleeding - clinically significant systemic infection - inadequate renal and/or liver function - nutritional deficiency (defined as serum folate 500 ng/mL - known sensitivity to iron administration - known (documented in medical records) positive HIV test - previously suspected of or confirmed (documented in medical records) to have neutralizing antibodies to rHuEPO (eg, reasons to suspect including prolonged lack of response to previous erythropoietin therapy, pure red cell aplasia, inexplicably low reticulocyte counts following previous erythropoietin therapy, or other clinical evidence in the judgment of the investigator) - received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1. - received any erythropoietic therapy within 4 weeks of randomization or any planned erythropoietic therapy between randomization and study day 1. - other investigational procedures - less than 30 days since receipt of any investigational drug or device (administered/used as part of an investigational study) that is not approved by the applicable regulatory authority (with the exception of Thalidomide) - subject of reproductive potential is evidently pregnant (eg, positive serum HCG test) or is breast feeding - subject of reproductive potential who is not using adequate contraceptive precautions - subject has known sensitivity to any of the products to be administered during dosing. - subject was previously randomized in this study - subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare hematopoietic response after 16 weeks of treatment with 500 mcg once every 3 weeks (Q3W) darbepoetin alfa and either IV iron or following standard practice (oral iron or no iron supplementation).;Secondary Objective: Compare: - impact on the time to hematopoietic response of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice. - impact on RBC transfusions of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice. - impact on change in hemoglobin of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice. - assess safety of 500 mcg darbepoetin alfa administered Q3W administered via the auto-injector with IV iron or following standard practice.;Primary end point(s): The proportion of subjects achieving a hematopoietic response (hgb > 12 g/dl or rise in hgb of > 2 g/dl) during the treatment period. | — |
Countries
Czech Republic, Denmark, Finland, Hungary, Italy, Sweden
Outcome results
None listed