UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000063 |
|---|---|
| Receipt number | 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 11:31:30 |
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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
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/
bun-hy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000109
