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A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.

A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients. - A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008932
Enrollment
55
Registered
2012-09-17
Start date
2012-08-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant lymphoma cancer.

Interventions

Palonosetron: day1 0.75mg (i.v.)

Sponsors

Hematology, Department of Medicine Kitasato University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who receive CHOP or R-CHOP therapy for malignant lymphoma cancer patients 2)No prior chemotherapy 3) Aged 20 years or older 4) Adequate organ function 5) ECOG performance status of 0 or 2 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) With other sever diseases 2) Clinical suspicion or history of metastasis to brain or meninges 3) Patients who need anticonvulsants therapy 4) Ascites and/or pleural effusion to need treatment 5) Pyloric stenosis and/or intestinal obstruction 6) Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 7) History of drug allergy 8) Pregnant or lactating women or women of childbearing potential, and no birth-control 9) Patient who doesn't have ability or intention that cooperates for procedure of the study 10) Not appropriate for the study at the physician's assessment

Design outcomes

Primary

MeasureTime frame
Complete Response Rate in overall phase(0-120 hours after chemotherapy)

Secondary

MeasureTime frame
Complete Response Rate in acute and delayed phase Complete Control Rate in overall, acute and delayed phase The proportion of patients without nausea in overall, acute and delayed phase Safety

Countries

Japan

Contacts

Public ContactHirotoshi Kamata

Department of Medicine Kitasato University, School of Medicine Hematology

0427788111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026