IMPACT Non Hodgkins Lymphoma (NHL) Study
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00903812
First received: May 14, 2009
Last updated: July 14, 2014
Last verified: July 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin's Lymphoma |
Other: No intervention |
| Study Type: | Observational |
| 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 ) |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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
| Enrollment: | 1837 |
| Study Start Date: | February 2007 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
No intervention - observational study
|
Other: No intervention
No intervention as observational study
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903812
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903812
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00903812 History of Changes |
| Other Study ID Numbers: | 20060297 |
| Study First Received: | May 14, 2009 |
| Last Updated: | July 14, 2014 |
| Health Authority: | Australia: Human Research Ethics Committee Denmark: Danish Medicines Agency France: CCTIRS: Advisory Committee on Medical research Data Processing France: CNIL: National Computers and Privacy Commission France:CNOM: National Council of the French Medical Association Greece: National Organization for Medicines Italy: Ministry of Health Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016