UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000032147