UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012382 |
|---|---|
| Receipt number | R000014478 |
| Scientific Title | Treatment protocol for adult acute lymphoblastic leukemia -ALL/MRD2014- |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2021/11/29 14:10:33 |
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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
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
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood & Marrow Transplant Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014478
