UMIN-CTR Clinical Trial

Basic information
Public title	The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Acronym	The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Scientific Title	The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Scientific Title:Acronym	The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Region	Japan

Condition
Condition	Malignant lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Complete response during chemotherapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Palonostron 0.75mg/body is administrated before chemotherapy. Palonpstron is administrated on day1 in the first course of chemotherapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Age of patient is more than 20 years old. 2)Patient is diagnosed as malignant lymphoma. 3)Patient is planned to received high-risk chemotherapy induced nausea and vomiting as below:CHOP,ESHAP,EPOCH,ABVd/Hyper-CVAD/MA,ICE,DeVIC,C-MOPP,CPA. 4)Patient has sufficient organ functio. 5)Patient has no ECG abnormality require treatment. 6)Performance Status(ECOG scale)of patient is 0 to 2. 7)Patient consent to participate in the study by writing.
Key exclusion criteria	1)Patient has severe complication require treatment. 2)Patient has more than CTCAE grade1 nausea and vomiting before chemotherapy. 3)Patient has hypersensitivity of Palonosetron or the other 5-HT3 antagonist. 4)Pregnant or nursing women. Patient refuses to contraception. 5)Patient is deemed inappropriate by doctors.
Target sample size	54

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Junji Suzumiya
Organization	Shimane University Hospital
Division name	Cancer center
Zip code
Address	Enyacho 89-1,Izumo-shi,Shimane
TEL	0853-23-2111
Email

Public contact
1st name of contact person	1st name Middle name Last name Tsutomu Takahahsi
Organization	Shimane University Hospital
Division name	Cancer center
Zip code
Address	Enyacho 89-1,Izumo-shi,Shimane
TEL	0853-23-2111
Homepage URL
Email	ben2106t@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital,cancer center
Institute
Department

Funding Source
Organization	Shimane University Hospital,cancer center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 05 Day
Date of IRB	2012 Year 08 Month 27 Day
Anticipated trial start date	2012 Year 09 Month 14 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 06 Month 13 Day

Other
Other related information

Management information
Registered date	2012 Year 09 Month 23 Day
Last modified on	2019 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010492