IMPACT Non Hodgkins Lymphoma (NHL) Study
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ClinicalTrials.gov Identifier: NCT00903812 |
Recruitment Status
:
Completed
First Posted
: May 18, 2009
Last Update Posted
: July 16, 2014
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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 |

Group/Cohort | Intervention/treatment |
---|---|
A
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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

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
Study Director: | MD | Amgen |
Additional Information:
Publications:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00903812 History of Changes |
Other Study ID Numbers: |
20060297 |
First Posted: | May 18, 2009 Key Record Dates |
Last Update Posted: | July 16, 2014 |
Last Verified: | July 2014 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |