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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037626
Receipt No. R000042900
Scientific Title Treatment protocol for adult acute lymphoblastic leukemia
Date of disclosure of the study information 2019/11/30
Last modified on 2019/08/08

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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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
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
2019 Year 08 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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