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 )
18 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
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 )
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.
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF
Outcome Time Frame:
At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Australia: Human Research Ethics Committee
Study ID:
20060297
NCT ID:
NCT00903812
Start Date:
February 2007
Completion Date:
January 2014
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
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