UMIN-CTR Clinical Trial

Public title

JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17

Acronym

JALSG-CS-17

Scientific Title

JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17

Scientific Title:Acronym

JALSG-CS-17

Region

Japan

Condition

AML(acute myeloid leukemia and related neoplasms),MDS(myelodysplastic syndromes),CMML(chronic myelomonocytic leukemia)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the influence of the treatment contents and complications on survival rate by clarifying the 5-year overall survival rate of AML, MDS and CMML in JALSG participating institutions.

Basic objectives2

Others

Basic objectives -Others

5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML

Key secondary outcomes

(1)Remission rate and survival rate in each therapy of initial induction therapy and re-induction therapy for AML.
(2)Influence of use/non-use of azacitidine and gemutuzumab ozogamicin on survival rate in AML.
(3)Remission rate and survival rate in each initial therapy using azacitidine in MDS.
(4)Use/Non-use of lenalidomide, deferasirox and erythropoietin, and survival rate in MDS.
(5)Remission rate and survival rate in each initial therapy using azacitidine in CMML.
(6)Influence of situation at the time of allogeneic hematopoietic stem cell transplantation, and of presence/absence of donor source and family donor on survival rate.
(7)Influence of comorbidity (by Charlson comorbidity index) on treatment outcome.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Aged 16 or older with all newly diagnosed untreated AML, MDS, CMML at participating institutions.
(2)Diseases are defined in accordance with WHO classification, 2016 edition.
(3)Acute leukemias of ambiguous lineage (acute undifferentiated leukemia, mixed phenotype acute leukemia (MPAL)) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are also included, except MDS/MPN other than CMML.

In order to strictly apply the WHO classification 2016 edition, following examinations are required in addition to the commonly performed chromosome examination: SF3B1 mutation in MDS, NPM1 mutation in AML, double CEBPA mutation, and RUNX1 mutation. Confirming that the presence or absence of history of these genetic examinations, classification is made on the assumption that there is no mutation for the case of absence. In the case of diagnosing AML with myelodysplasia-related changes (AML-MRC) based on the preceding hematopoietic abnormality, it is assumed that a hematopoietic abnormality period of 3 months or more has been confirmed.

Key exclusion criteria

(1)With a history of chemotherapy or hematopoietic stem cell transplantation in AML, MDS or CMML; however, treatment-related AML, MDS and CMML which developed after the following therapies are included: therapy for preceding blood abnormalities (such as immunosuppressive therapy for aplastic anemia), chemotherapy for malignancy of other tissues, radiation therapy (such as radiation therapy for preceding breast cancer, chemotherapy for preceding malignant lymphoma).
(2)In case of progress from MDS or CMML to AML, re-registration is not required if it is registered with preceding MDS or CMML. MDS and CMML which had already been diagnosed outside the JALSG participating institutions are excluded. The case which developed to AML after having been diagnosed as MDS by other than those institutions and transferred to the own institution is registered as AML (with preceding blood disease). (Even if the history of abnormality of blood count is long, newly diagnosed MDS and CMML in the own institution are not excluded.)

Target sample size

4900

Name of lead principal investigator

1st name	Hisayuki
Middle name
Last name	Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Hematology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan

TEL

022-717-7165

Email

hisayuki.yokoyama.a1@tohoku.ac.jp

Name of contact person

1st name	Hisayuki
Middle name
Last name	Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Hematology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan

TEL

022-717-7165

Homepage URL

http://www.jalsg.jp/

Email

hisayuki.yokoyama.a1@tohoku.ac.jp

Institute

Japan Adult Leukemia Study Group (JALSG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

6542

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

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

05

Month

25

Day

Date of IRB

2017

Year

06

Month

17

Day

Anticipated trial start date

2017

Year

06

Month

29

Day

Last follow-up date

2027

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Primary outcomes
5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML

Secondary outcomes
(1)Remission rate and survival rate in each therapy of initial induction therapy and re-induction therapy for AML.
(2)Influence of use/non-use of azacitidine and gemutuzumab ozogamicin on survival rate in AML.
(3)Remission rate and survival rate in each initial therapy using azacitidine in MDS.
(4)Use/Non-use of lenalidomide, deferasirox and erythropoietin, and survival rate in MDS.
(5)Remission rate and survival rate in each initial therapy using azacitidine in CMML.
(6)Influence of situation at the time of allogeneic hematopoietic stem cell transplantation, and of presence/absence of donor source and family donor on survival rate.
(7)Influence of comorbidity (by Charlson comorbidity index) on treatment outcome.

Registered date

2017

Year

06

Month

28

Day

Last modified on

2023

Year

02

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032029