UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010619
Receipt number R000012415
Scientific Title Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Date of disclosure of the study information 2013/05/15
Last modified on 2020/05/07 15:06:54

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Basic information

Public title

Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.

Acronym

Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)

Scientific Title

Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.

Scientific Title:Acronym

Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)

Region

Japan


Condition

Condition

Philadelphia chromosome negative precursor B acute lymphoblastic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate safety and efficacy of pediatric like protocols, which have a more intense use of agents such as L-asparaginase and steroids, as well as to clarify the relationship between prognosis and steroid reactivity in the treatment of newly diagnosed previously untreated adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3 year event free survival (EFS)

Key secondary outcomes

Complete remission rate
Adverse event rate
3 year overall survival (OS), and relapse free survival (RFS)
Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD
Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS


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

Induction therapy, Consolidation therapy, Maintenance therapy

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Recognized ALL
2. Precursor B-ALL (diagnosed by WHO Classification)
3. Age 15 to 64
4. Performance Status: 0 to 3
5. Adequate hepatic, renal and cardiac function
6. Written informed consent

Key exclusion criteria

1. Previously treated with leukapheresis
2. Congestive heart failure
3. Recent history of myocardial infarction
4. Malignant hypertension
5. Lung fibrosis
6. Interstitial pneumonitis
7. Severe comorbidity
(diabetes mellitus, infection or liver cirrhosis)
8. Positive anti-HIV antibody or HBs antigen
9. Thrombosis which need treatment
10. Psychological disorders
11. Other active neoplasms
12. Pregnant and/or lactating woman
13. Judged to be inadequate

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Hatta

Organization

JALSG-ALL213 research secretariat

Division name

Hematology and Rheumatology, Nixon University School of Medicine

Zip code

173-8610

Address

30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

hatta.yoshihiro@nihon-u.ac.jp


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Hatta

Organization

JALSG-ALL213 research secretariat

Division name

Hematology and Rheumatology, Nixon University School of Medicine

Zip code

173-8610

Address

30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL

http://www.jalsg.jp

Email

hatta.yoshihiro@nihon-u.ac.jp


Sponsor or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Deveopment

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo Hokuyu Hospital, IRB

Address

6-6-5-1 Higashi-Sapporo, Shiroishi-ku, Sappro

Tel

011-865-0111

Email

iso.hokuyu@gmail.com


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

2013 Year 05 Month 15 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

211

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

Completed

Date of protocol fixation

2013 Year 03 Month 09 Day

Date of IRB

2013 Year 04 Month 22 Day

Anticipated trial start date

2013 Year 07 Month 07 Day

Last follow-up date

2020 Year 06 Month 02 Day

Date of closure to data entry

2020 Year 10 Month 02 Day

Date trial data considered complete

2021 Year 02 Month 02 Day

Date analysis concluded

2021 Year 06 Month 02 Day


Other

Other related information



Management information

Registered date

2013 Year 04 Month 30 Day

Last modified on

2020 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name