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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name