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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020853
Receipt No. 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

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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
Institute Hokkaido University Hospital
Institute
Department

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
URL(English) https://upload.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


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