UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025044
Receipt number R000028820
Scientific Title Treatment protocol for acute promyelocytic leukemia FBMTG APL2017
Date of disclosure of the study information 2017/01/01
Last modified on 2017/07/28 09:59:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Treatment protocol for acute promyelocytic leukemia
FBMTG APL2017

Acronym

FBMTG APL2017

Scientific Title

Treatment protocol for acute promyelocytic leukemia
FBMTG APL2017

Scientific Title:Acronym

FBMTG APL2017

Region

Japan


Condition

Condition

acute promyelocytic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine efficacy and safety of therapy which consisted with ATRA combined with ATO in early stage as induction therapy for acute promyelocytic leukemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3 years disease-free survival

Key secondary outcomes

5 years disease free survival
CR rate
Perfection rate of protocol regimen
treatment-related toxicities
Incidence rate of differentiation syndrome
Frequency of additional administration of idarubicune
Frequency of mutation in PML-RARA fusion gene and its influence for therapy efficacy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induction:ATRA 45mg/m2 2-3x po day1-max day74
Consolidation:ATO 0.15mg/kg div day15-max day74

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

15 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Acute promyelocytic leukemia by WHO classification
2. The first time treatment example which does not catch chemotherapy or the radiotherapy
3. The case that is equal to or less than 65 years old more than age 15 years old
4. Performance status 0-2
5. A case without the dangerously ill internal organs disorder
6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents

Key exclusion criteria

1. The case having double cancers
2. The case with an infectious disease having difficulty with control
3. The case with a severe mental disorder
4. The pregnancy or breast-feeding woman
5. The case that the medical attendant judged to be inappropriate

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken takase

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Hematology

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Email

fbmtg@intmed1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name FBMTG Study Office

Organization

FBMTG

Division name

FBMTG Study Office

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5315

Homepage URL


Email

fbmtg@intmed1.med.kyushu-u.ac.jp


Sponsor or person

Institute

FBMTG

Institute

Department

Personal name



Funding Source

Organization

Research Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

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

2017 Year 01 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2017 Year 03 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

2016 Year 11 Month 29 Day

Last modified on

2017 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name