IMPACT Non Hodgkins Lymphoma (NHL) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00903812|
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment|
|Non-Hodgkin's Lymphoma||Other: No intervention|
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.
|Study Type :||Observational|
|Actual Enrollment :||1837 participants|
|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 )|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||March 2014|
No intervention - observational study
Other: No intervention
No intervention as observational study
- 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) ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903812