FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressiv… (NCT00125723) | Clinical Trial Compass
CompletedPhase 4
FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy
2,252 participantsStarted 2004-05
Plain-language summary
The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: - Pathologically confirmed diagnosis of the following malignancies: breast, non-Hodgkin's lymphoma (NHL), Hodgkin's disease, ovarian, colorectal, lung or other - Planned administration of a new myelosuppressive every 14 (q14), q21, or q28 day chemotherapy - Written informed consent for participation in the study before any study-specific procedures are performed, including screening and registration Exclusion Criteria: - Planned concomitant therapeutic radiation - Diagnosis of acute or chronic leukemia or myelodysplastic syndrome - Prior stem-cell transplantation (includes bone-marrow transplantation) - Medical diagnosis of chronic neutropenia of any cause not related to cancer - Current cytotoxic, biologic, or immunologic therapy for unrelated conditions - Subject has active infection requiring treatment - Known HIV-positive subjects - Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or is breast feeding - Subject of child-bearing potential is not using adequate contraceptive precautions - Known sensitivity to E. coli derived drug products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® growth hormone, INTRON A®) - Any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Subject is currently enrolled in, or has not yet completed at least 30 days since ending another device or drug tri…
What they're measuring
1
dose delays and dose reductions and neutropenic events