UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028082 |
|---|---|
| Receipt number | 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 14:00:39 |
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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
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
ma.oncology@kyowa-kirin.co.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032147
