UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020853
Receipt number R000023625
Scientific Title Pilot study of a pegfilgrastim injection as an inducer to mobilize CD34 positive stem cells into the peripheral blood
Date of disclosure of the study information 2016/02/02
Last modified on 2018/04/27 12:43:11

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Basic information

Public title

Pilot study of a pegfilgrastim injection as an inducer to mobilize CD34 positive stem cells into the peripheral blood

Acronym

Peg-G16 study

Scientific Title

Pilot study of a pegfilgrastim injection as an inducer to mobilize CD34 positive stem cells into the peripheral blood

Scientific Title:Acronym

Peg-G16 study

Region

Japan


Condition

Condition

Malignant Lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the mobilization of CD34 positive stem cells into peripheral blood after pegfilgrastim injection

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Actual number of CD34 positive stem cells after pegfilgrastim injection

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1 Disease confirmed malignant lymphoma
2 Patients must be more than 18 years old and less than 65 years old
3 We don't care prior therapy
4 It will be expected to have neutropenia more than grade 3 after treatment with chemotherapy
5 Patients must receive pegfilgrastim in prior therapy before starting this study
6 Performance status is less than 2
7 Life expectancy more than 3 months without chemotherapy
8 Written informed consent must be obtained prior to any screening procedures

Key exclusion criteria

1 Patients must not have any allergy with pegfilgrastim or filgrastim in the past
2 Pregnant or nursing women
3 SpO2 less than 94%: room air
4 Cardiac dysfunction: LVEF<50%
5 Liver dysfunction, Renal dysfunction
ALT more than 5*ULN
T.Bil more than 5*ULN
sCr more than 2*ULN
6 HIV1/2 infection
7 Uncontrolled mental disease
8 Uncontrolled hypertension
9 Uncontrolled diabetes
10 Uncontrolled infectious disease
11 Dual malignancy
12 Patients were judged unqualified for this study by attending physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Goto

Organization

Hokkaido University Hospital

Division name

Department of Hematology

Zip code


Address

W7, N15, Kita-ku, Sapporo, Hokkaido

TEL

011-706-1161

Email

hidekigt@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Goto

Organization

Hokkaido University Hospital

Division name

Department of Hematology

Zip code


Address

W7, N15, Kita-ku, Sapporo, Hokkaido

TEL

011-706-1161

Homepage URL


Email

hidekigt@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyowa Hakko 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


Address


Tel


Email



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

2016 Year 02 Month 02 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.bloodjournal.org/content/130/Suppl_1/4478?sso-checked=true

Number of participants that the trial has enrolled


Results

Our data indicated that 3.6mg pegfilgrastim on day 7 can efficiently mobilize CD34+ cells to peripheral blood without any severe adverse events.

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

2015 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 29 Day

Last follow-up date

2017 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 03 Month 14 Day


Other

Other related information

Nothing special


Management information

Registered date

2016 Year 02 Month 02 Day

Last modified on

2018 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023625


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name