UMIN-CTR Clinical Trial

Basic information
Public title	Treatment protocol for adult acute lymphoblastic leukemia -ALL/MRD2014-
Acronym	ALL/MRD2014
Scientific Title	Treatment protocol for adult acute lymphoblastic leukemia -ALL/MRD2014-
Scientific Title:Acronym	ALL/MRD2014
Region	Japan

Condition
Condition	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	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	3 years disease-free survival
Key secondary outcomes	5 years disease-free survival, CR rate, treatment-related toxicities

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. In adult BCR/ABL positive ALL, patients will receive induction therapy combined with dasatinib. Every patient will proceed to allogeneic HSCT whenever possible.
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 or breast-feeding woman 6. the case that the medical attendant judged to be inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Koji Nagafuji / Yoshikiyo Ito Middle name Last name Koji Nagafuji / Yoshikiyo Ito
Organization	Koji Nagafuji / Yoshikiyo Ito Kurume University Hospital / Harasanshin Hospital
Division name	Division of Hematology and Oncology / Department of Hematology
Zip code	8300011
Address	67 Asahi-machi, Kurume 830-0011, Japan / 1-8 Taihakumachi, Hakata Ward, Fukuoka
TEL	0942-31-7852
Email	knagafuji@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name The secretariat Middle name Last name The secretariat
Organization	Fukuoka Blood & Marrow Transplant Group
Division name	Head office of FBMTG
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Homepage URL	http://f-bmtg.jp/index.html
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Fukuoka Blood & Marrow Transplant Group
Institute
Department

Funding Source
Organization	Research Foundation for Community Medicine
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	Kurume University Medical Ethics Committee
Address	67 Asahi-machi, Kurume 830-0011
Tel	0942-31-7917
Email	i_rinri@kurume-u.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	2014 Year 01 Month 01 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	No longer recruiting
Date of protocol fixation	2013 Year 11 Month 22 Day
Date of IRB	2014 Year 01 Month 15 Day
Anticipated trial start date	2014 Year 02 Month 16 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 22 Day
Last modified on	2021 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014478