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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001519
Receipt No. R000001833
Scientific Title Treatment protocol for adult acute lymphocytic leukemia -ALL/ MRD2008-
Date of disclosure of the study information 2008/12/01
Last modified on 2016/05/22

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Basic information
Public title Treatment protocol for adult acute lymphocytic leukemia
-ALL/ MRD2008-
Acronym ALL/MRD2008
Scientific Title Treatment protocol for adult acute lymphocytic leukemia
-ALL/ MRD2008-
Scientific Title:Acronym ALL/MRD2008
Region
Japan

Condition
Condition adult acute lymphocytic 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 Pragmatic
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 imatinib. 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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Nagafuji
Organization Kurume University School of Medicine
Division name Hematology/Oncology
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan
TEL 0942-31-7852
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Miyamoto
Organization Kyushu University Hospital
Division name Hematology/Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Homepage URL
Email toshmiya@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Fukuoka Blood & Marrow Transplant Group
Institute
Department

Funding Source
Organization Fukuoka Blood & Marrow Transplant Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 12 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
2008 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 11 Month 21 Day
Last modified on
2016 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001833

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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