Status:
WITHDRAWN
Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
Lead Sponsor:
Australasian Leukaemia and Lymphoma Group
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The contribution of predni...
Detailed Description
The aim of this study will be to investigate the incidence and severity of CINV in patients receiving R-CHOP for the treatment of non-Hodgkin lymphoma and standardised antiemetic prophylaxis. The stu...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of non Hodgkin's Lymphoma
- Newly diagnosed or relapsed patients who are chemotherapy-naïve or who have not received chemotherapy in the last 12 months. Pre-phase therapy with prednisolone and/or vincristine for \< one week duration prior to commencement of cycle 1 of R-CHOP is permissible
- Intended to receive R-CHOP every 14 or 21 days for minimum 3 cycles with rituximab planned to be given with CHOP on day 1 or fractionated over days 1 and 21.
- Males and females, age 18 years or older
- Are reasonably expected to be able to complete the CINV tool
- Willing to complete assessments and tool as required for the study
- ECOG (Eastern Cooperative Oncology Group) performance status score of 2 or less
- Has provided written informed consent
Exclusion
- Women who are pregnant or lactating.
- Previous adverse reaction to the standard anti-emetics proposed in the study
- Contraindications to the use of the anti-emetics included as standard of care in the study (e.g. cardiac, liver function)
- Participation in other therapeutic studies investigating CINV.
- Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01843868
Start Date
January 1 2012
End Date
June 1 2015
Last Update
August 7 2024
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