UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.
Acronym	A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.
Scientific Title	A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.
Scientific Title:Acronym	A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.
Region	Japan

Condition
Condition	haematological malignancies
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of palonosetron on CINV in patients with haematological malignancies receiving following chemotherapy. CHOP, R-CHOP, ABVD, Bendamustine, R-Bendamustine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Complete Control Rate in overall phase(0-120 hours after chemotherapy)
Key secondary outcomes	Complete Response Rate in overall phase(0-120 hours after chemotherapy) The proportion of patients without nausea in overall, acute and delayed phase Complete Control Rate in acute phase(0-24 hours after chemotherapy) Complete Control Rate in delayed phase(25-120 hours after chemotherapy) Complete Response Rate in acute phase(0-24 hours after chemotherapy) Complete Response Rate in delayed phase(25-120 hours after chemotherapy) The proportion of patients without nausea in acute phase The proportion of patients without nausea in delayed phase

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Palonosetron: day1 0.75mg (i.v.)
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) Aged 20 years or older 2) diagnosed as haematological malignancies 3) Planed following chemotherapy CHOP R-CHOP ABVD Bendamustine R-Bendamustine 4) Adequate organ function 5) ECOG performance status of 0-2 6) Written informed consent
Key exclusion criteria	1) With other severe diseases 2) No double cancer 3) Hypersensitivity for palonosetron 4) History of palonosetron use 5) History of receiving high emetic risk chemotherapy classified according to Antiemetic Guideline for Patients with Malignancies in Japan 6) With nausea and/or vomiting 7) Require continuous administration of systemic steroids 8) Not appropriate for the study at the physician's assessment
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Akashi
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Medicine and Biosystemic Science
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL	092-641-1151
Email	mayako49@pharm.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Mayako Middle name Last name Uchida
Organization	Kyushu University Hospital
Division name	Department of Pharmacy
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL	0926425940
Homepage URL
Email	mayako49@pharm.med.kyushu-u.ac.jp

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

Funding Source
Organization	None
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	Kyushu University Hospital
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
Tel	092-641-1151
Email	mayako49@pharm.med.kyushu-u.ac.jp

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	2013 Year 06 Month 01 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 29 Day
Date of IRB	2012 Year 06 Month 21 Day
Anticipated trial start date	2012 Year 07 Month 30 Day
Last follow-up date	2014 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 05 Month 17 Day
Last modified on	2021 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012516