IMPACT Non Hodgkins Lymphoma (NHL) Study
|Official Title:||A Retrospective and Prospective Observational Study Reviewing Supportive Care Management of NHL Patients Treated With CHOP-14 or 21 Chemotherapy(With or Without Rituximab) (CHOP = Cyclophosphamide, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine), Prednisone Chemotherapy )|
- Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF [ Time Frame: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment) ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
This is an observational study. No bio-specimens are being collected.
Time perspective - this study enrolls both retrospective and prospective subjects
|Study Start Date:||February 2007|
|Study Completion Date:||March 2014|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
No intervention - observational study
Other: No intervention
No intervention as observational study
This is a multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.
Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903812