IMPACT Non Hodgkins Lymphoma (NHL) Study

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Other: No intervention

• Registration Number: NCT00903812
• Lead Sponsor: Amgen

Brief Summary

This is 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.

Detailed Description

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2008-12
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Study Completion: 2014-03
• Status Verified: 2015-09
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1837

Inclusion Criteria

• Subjects greater than or equal to 18 years old
• Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
• Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
• Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required

Exclusion Criteria

• Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No intervention	No intervention - observational study

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF	At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)