UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008471
Receipt number R000009629
Scientific Title Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)
Date of disclosure of the study information 2012/07/19
Last modified on 2023/01/26 15:10:55

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Basic information

Public title

Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)

Acronym

Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)

Scientific Title

Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)

Scientific Title:Acronym

Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)

Region

Japan


Condition

Condition

Adult acute promylocytic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Investigate whether post remission therapy with arsenic trioxide (ATO) and tamibarotene (Am80), which are more specific and less toxic for acute promylocytic leukemia (APL), will improve the outcome or not in APL over 65 years old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3-year event free survival (EFS)

Key secondary outcomes

1. Complete remission rate (CR)
2. 3- and 5-year disease free survival (DFS)of patients in CR
3. 3- and 5-year overall survival (OS)
4. 5-year event free survival (EFS)
5. CR, DFS and OS of each group
6. Adverse events.
7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis
8. Coagulation and fibrinolysis factors, and their effects on prognosis.
9. Quality of life
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
11. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.


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

all-trans retinoic acid
idarubicin
arsenic trioxide
tamibarotene (Am80)

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Newly diagnosed APL (FAB:M3 or M3v)
2. Performance status (ECOG):0-2
3. Adequate cardiac, pulmonary, hepatic and renal function
4. Written informed consent

Key exclusion criteria

1. History of myelodysplastic syndrome
2. Atypical acute leukemia
3. Uncontrollable infection
4. Severe co-morbidity
5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody
6. Other active neoplasm
7. Pregnant and/or lactating woman
8. Psychological disorders
9. Patients who have a difficulty to enter the study.

Target sample size

63


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Takeshita

Organization

Hamamatsu University School of Medicine

Division name

Internal Medicine

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan

TEL

(+81)-53-433-4993

Email

akihirot@hama-med.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Takeshita

Organization

Hamamatsu University School of Medicine

Division name

Internal Medicine

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan

TEL

(+81)-53-433-4993

Homepage URL

http://www.jalsg.jp/

Email

akihirot@hama-med.ac.jp


Sponsor or person

Institute

the Japan Adult Leukemia Study Group (JALSG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

the Nonprofit Supportive Organization for Cooperative Study on Adult Leukemia Treatment

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board of Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Hamamatsu, Higashi-ku, 431-3192, Japan

Tel

(+81)-53-435-2676

Email

kenkyou@hama-med.ac.jp


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

2012 Year 07 Month 19 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

2012 Year 05 Month 30 Day

Date of IRB

2012 Year 05 Month 30 Day

Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 01 Month 28 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 07 Month 19 Day

Last modified on

2023 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name