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
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
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
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
