UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018385 |
|---|---|
| Receipt number | R000020492 |
| Scientific Title | Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF |
| Date of disclosure of the study information | 2015/07/22 |
| Last modified on | 2015/07/22 16:16:31 |
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Basic information
Public title
Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF
Acronym
Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF
Scientific Title
Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF
Scientific Title:Acronym
Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF
Region
| Japan |
Condition
Condition
POEMS syndrome
Classification by specialty
| Hematology and clinical oncology | Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of low-dose cyclophosphamide plus G-GSF regimen for hematopoietic progenitor cell harvest in POEMS syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Patients collecting >= 2*10^6 CD34+ cells/kg on day 1 (%)
Key secondary outcomes
Safety
Effect of this regimen on engraftment
Incidence of adverse events (Grade 3)
The day of first apheresis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study is composed of the following two steps of therapy.
1)PBSC mobilization using low dose cyclophosphamide and G-CSF
2)autologous peripheral stem cell transplantation after high dose 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with POEMS syndrome (confirmed by diagnostic criteria)
2)The plasma cell in bone marrow counts <= 5%
3) Previous trearments with lenalidomide <= 4 courses
4) Patients who have the latest treatment more than 2 weeks before enrollment
5)age >=20 and <= 70
6) Patients who have the following laboratory values within 14 days before enrollment
.neutrophil count >= 1000/mm3
. Hemoglobin>=8.0g/dl
. platelet count >= 100,000/mm3
. ALT <= 2.5 x upper limit of normal AST <= 2.5 x upper limit of normal
. serum total bilirubin <= 2.0mg/dl
. serum creatinine <= 2.0mg/dl
. Normal ECG or asymptomatic minor ECG change
. SpO2>=95%
7) Patients who are expected to survive more than 3 months
8) voluntary written informed consent
Key exclusion criteria
1) Patients with plasma cells in CBC
2) Pregnant or nursing women. Patients reuse to contraception during examination period
3) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
4) Patients with serious mental disorders
5) Patients with HBs antigen-positive
6) Patients with HIV antibody-positive
7) Patients with a history of severe allergy to the drugs
8) Patients with serious active infection
9) Patients who are determined to be inappropriate for this study by physicians
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiaki Nakaseko |
Organization
Chiba University Hospital
Division name
Department of Hematology
Zip code
Address
1-8-1Inohana, Chuo-ku,Chiba city
TEL
043-222-7171
chiaki-nakaseko@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shio Sakai |
Organization
Chiba University Hospital
Division name
Department of Transfusion Medicine and Cell Therapy
Zip code
Address
1-8-1Inohana, Chuo-ku,Chiba city
TEL
043-222-7171
Homepage URL
shio-sakai@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology
Chiba University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 22 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020492
