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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028082
Receipt No. R000032147
Scientific Title Study of evaluating shortening of a hospitalization period after salvage therapy in patients with relapsed or refractory malignant lymphoma
Date of disclosure of the study information 2017/07/05
Last modified on 2019/07/08

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Basic information
Public title Study of evaluating shortening of a hospitalization period after salvage therapy in patients with relapsed or refractory malignant lymphoma
Acronym Evaluation of post-salvage therapy hospitalization period in patients with malignant lymphoma
Scientific Title Study of evaluating shortening of a hospitalization period after salvage therapy in patients with relapsed or refractory malignant lymphoma
Scientific Title:Acronym Evaluation of post-salvage therapy hospitalization period in patients with malignant lymphoma
Region
Japan

Condition
Condition Relapsed or refractory malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating safety and feasibility of shortening of a hospitalization period after pegfilgrastim treatment in patients with salvage therapy, who are eligible to outpatient management criteria
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of outpatient management period (days)
Key secondary outcomes 1) Readmission rate due to febrile neutropenia
2) All-cause readmission rate
3) Number of transfusions (RBC, Platelet)
4) Number of outpatient visits
5) Relative dose intensity
6) Cost analysis
7) Utilization rate of antibiotics
8) Patient satisfaction
9) Adverse events

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 Patients receive a single subcutaneous injection of pegfilgrastim (3.6 mg) 2 days after 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)Relapsed or refractory non-hodgkins lymphoma and hodgkins lymphoma
2)Age >= 20 years old at informed consent
3)ECOG PS <= 2
4)Patients who are going to receive (R)EPOCH, CHASE(R), (R)DeVIC or (R)ESHAP regimen.
5)Patients who meet the following criteria within 14 days before salvage therapy.
Neutrophil count >= 1,000/ul
Platelet >= 50,000/ul
Total bilirubin level <= 2 times the upper normal limit in institute
Serum creatinine <= 1.5mg/dl

Key exclusion criteria 1)Patients who have a possibility of severe infection after the entry or active infection at the entry.
2)Pregnant or breast-feeding females and females who have a possibility of pregnancy.
3)Patients who have any other inadequacy for this study by physicians.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Iwasaki
Organization National Hospital Organization Kyushu Medical Center
Division name Division of Hematology
Zip code 810-8563
Address 1-8-1 Jigyohama, Chuo-Ku, Fukuoka
TEL 092-852-0700
Email iwasakih@kyumed.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Nukada
Organization Kyowa Kirin
Division name Medical Affairs
Zip code 100-0004
Address 1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL 03-5205-7200
Homepage URL
Email ma.oncology@kyowa-kirin.co.jp

Sponsor
Institute National Hospital Organization Kyushu Medical Center
Institute
Department

Funding Source
Organization Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Hospital Organization Review Board for Clinical Trials Kyushu
Address Fukuoka 1-8-1 Jigyohama Chuo-ku Fukuoka 810-8563 Japan
Tel 092-852-0700
Email rinri@kyumed.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs071180008
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 05 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 Terminated
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
2020 Year 12 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
2017 Year 07 Month 05 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032147

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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