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

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 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

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

Value
https://center6.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