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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000063
Receipt No. R000000109
Scientific Title Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)
Date of disclosure of the study information 2005/08/17
Last modified on 2011/10/27

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Basic information
Public title Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)
Acronym Randomized Controlled Trial to Test Efficacy of High-Dose MTX for ALL (JALSG ALL202-O)
Scientific Title Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)
Scientific Title:Acronym Randomized Controlled Trial to Test Efficacy of High-Dose MTX for ALL (JALSG ALL202-O)
Region
Japan

Condition
Condition Acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to investigate clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL negative ALL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival at 3 years
Key secondary outcomes Toxicity, the rate of complete remission

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.
Interventions/Control_2 Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.
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
25 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Previously untreated BCR-ABL-negative ALL (2) Age between 25 and 64 years (3) Performance status between 0 and 3 (ECOG criteria) (4) Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs) (5) Written informed consent to participate the trial
Key exclusion criteria (1) Uncontrolled active infection (2) Another severe and/or life-threatening disease (3) Positive for HIV antibody and/or HBs antigen tests (4) Another primary malignancy which is clinically active and/or requires medical interventions (5) Pregnant and/or lactating woman (6) Past history of renal failure
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Naoe
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2145
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiko Hayakawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2145
Homepage URL http://www.jalsg.jp/
Email bun-hy@med.nagoya-u.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Japan: Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00131027
Org. issuing International ID_1 Clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 17 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
2002 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2002 Year 09 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 17 Day
Last modified on
2011 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000109

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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