A Randomized Open-Label Study of Darbepoetin alfa Administered Every Three Weeks with or without Parenteral Iron in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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 < 11 g/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- of legal age at the time written informed consent is obtained
- written informed consent must be obtained from the subject or legally accepted representative before any study-specific-procedure, including screening procedures, is performed
Are the trial subjects under 18?
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

- 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 < 4.5 nmol/L (< 2.0 ng/mL) or vitamin B12 <148 pmol/L (< 200 pg/mL))
- iron deficiency (transferrin saturation < 15 % and serum ferritin < 10 ng/mL. (Subjects must have both to be excluded.)
- serum ferritin > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Updated 3/19/2012