UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010746 |
|---|---|
| Receipt number | R000012516 |
| Scientific Title | A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies. |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2021/06/02 12:17:22 |
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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
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
mayako49@pharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Hematology, Department of Medicine Kitasato University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012516
