UMIN-CTR Clinical Trial

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
Institute	Japan Adult Leukemia Study Group
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012415