UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001413 |
|---|---|
| Receipt number | R000001716 |
| Scientific Title | Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16). |
| Date of disclosure of the study information | 2008/10/05 |
| Last modified on | 2010/10/30 14:29:03 |
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Basic information
Public title
Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16).
Acronym
Phase 2 study of induction and early consolidation therapy for ALL in children (TCCSG ALL L04-16).
Scientific Title
Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16).
Scientific Title:Acronym
Phase 2 study of induction and early consolidation therapy for ALL in children (TCCSG ALL L04-16).
Region
| Japan |
Condition
Condition
Acute Lymphoblastic Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate efficacy and safety for treating pediatric ALL with conventional induction and early consolidation therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of complete remission at the completion of early consolidation.
Key secondary outcomes
1.The complete remission induction rate
2.The frequency of therapy toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For standard and intermediate risk patients;
Induction therapy-A (Week 1-6): PSL, VCR, THP-ADR, L-ASP, MTX, Ara-C, HDC.
Consolidation therapy-A for standard and intermediate risk patients (Week 8-10): 6MP, Ara-C, CPM, MTX, HDC.
For high risk patients;
Induction therapy-B (Week 1-6): PSL, VCR, THP-ADR,DNR, CPA, L-ASP, MTX, Ara-C, HDC.
Early Consolidation therapy-B (Week 8): DEX, MTX, CPA, Ara-C, L-ASP, HDC.
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Previously untreated ALL,
(2) Age between 1 and 18 years,
(3) Karnofsky Performance status score >50,
(5) Written informed consent to participate the trial.
Key exclusion criteria
(1)Symptomatic intracranial hemorrhage
(2) Uncontroled infection,
(3) Double cancer, Secondary leukemia,
(4) Down syndrome,
(5) Pregnant, lactating woman,
(6) Inadequate functioning of the liver (ALT>200 and serum total bilirubin level > 1.5 mg/dL), kidneys (serum creatinine level >= 1.5 mg/dL),
(7) cardiac dysfunction, pulmonary dysfunction
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ohara |
Organization
Toho University
Division name
Omori Hospital, Dep.of Transfusion
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ohara |
Organization
Toho University
Division name
Omori Hospital, Dep.of Transfusion
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
aohara@med.toho-u.ac.jp
Sponsor or person
Institute
Tokyo Children's Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
1.Ministry of Health, Labor and Welfare, "Study on establishment of the multicenter clinical study for standard therapy to pediatric sarcoma"
2.Children's Cancer Association of Japan
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
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 | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Interim analysis of the 150 patients. Complete remission rate at completion of early consolidation is estimated as 97%. No unexpected treatment toxicity was reported.
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
Completed
Date of protocol fixation
| 2004 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 02 | Day |
Last modified on
| 2010 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001716
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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