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Study Complete
Sponsor ID
20060297

IMPACT Non Hodgkins Lymphoma (NHL) study

Sponsor ID
20060297
Clinicaltrials.gov ID
NCT00903812
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
pegfilgrastim
Type
Observational
Masking
N/A
Enrollment
1837
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF

Timeframe: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Lymphoma
    • Sex
    All
    Trial Dates
    Feb 2007 - Dec 2008
    Inclusion and Exclusion 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