Clareo Health | Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female adults (age \> / = 18 years)
Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
Planned to receive primary prophylaxis with filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle.
Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) label.
Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
Informed written consent to participate in the study by patients or their legal guardian.
You may not be if
Patients with myeloid malignancies, with the exception of multiple myeloma.
Sensitivity to filgrastim biosimilar or any other CSF.
Hypersensitivity to E. coli-derived proteins.
Radiotherapy to ≥ 20% of total body bone.
Infection within two weeks of starting current line of chemotherapy.
Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
Patients with willfully negligent nonadherence to their cancer treatment.
Use of any investigational agent in the 30 days prior to enrollment.
Women of childbearing potential not using the contraception method(s) described above.
