UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment protocol for adult acute lymphocytic leukemia -ALL/ MRD2008-
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Koji Nagafuji
Organization	Kurume University School of Medicine
Division name	Hematology/Oncology
Address	67 Asahi-machi, Kurume 830-0011, Japan
TEL	0942-31-7852
Email

Public contact
Name of contact person	Toshihiro Miyamoto
Organization	Kyushu University Hospital
Division name	Hematology/Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001833