UMIN-CTR Clinical Trial

Basic information
Public title	Treatment protocol for adult acute lymphoblastic leukemia
Acronym	ALL/MRD2019
Scientific Title	Treatment protocol for adult acute lymphoblastic leukemia
Scientific Title:Acronym	ALL/MRD2019
Region	Japan

Condition
Condition	adult acute lymphoblastic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We plan the risk-adjusted treatment protocol for adult acute lymphocytic leukemia. The risks are determined by the MRD status post consolidation treatment. High-risk patients will proceed to allogeneic hematopoietic stem cell transplantation, while low-risk patients will proceed to maintenance treatment.
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

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	In adult BCR/ABL negative ALL, the indication of allogeneic HSCT will be determined by the MRD status. High-risk patients will proceed to allogeneic HSCT. Low-risk patients will proceed to maintenance treatment which is less toxic than HSCT. (nonPh ALL/MRD2019 protocol) In adult BCR/ABL positive ALL, patients will receive induction therapy combined with dasatinib or ponatinib. Every patient will proceed to allogeneic HSCT whenever possible. (Ph ALL/MRD2019 protocol)
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	16 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. acute lymphoblastic leukemia by WHO classification 2. peroxidase positive rate of the blast cell, 3% are less than it 3. The first time treatment example which does not catch chemotherapy or the radiotherapy 4. The case that is equal to or less than 65 years old more than age 15 years old 5. Performance status 0-2 6. A case without the dangerously ill internal organs disorder T.Bil equal to or less than 2.0mg/dL, Cr equal to or less than 2.0mg/dL 7. The case that an agreement by the document is provided from a patient on explanation because of final examination contents
Key exclusion criteria	1. B-ALL(L3) of the blast cell cell surface immune globulin positive 2. A case having double cancers 3. A case with an infectious disease having difficulty with control 4. A case with a severe mental disorder 5. The pregnancy woman 6. the case that the medical attendant judged to be inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Akashi
Organization	Kyushu University
Division name	Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5315
Email	jsct-office@umin.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Miyamoto
Organization	Kyushu University
Division name	Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5315
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	Japan Study Group for Cell Therapy and Transplantation
Institute
Department

Funding Source
Organization	The Regional Medicine Research Foundation
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	NPO Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 Fukuoka
Tel	092-643-7171
Email	email@crnfukuoka.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	2019 Year 11 Month 30 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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 10 Month 02 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2030 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 08 Day
Last modified on	2022 Year 09 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042900