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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001413
Receipt No. 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

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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
Email

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
Email aohara@med.toho-u.ac.jp

Sponsor
Institute Tokyo Children's Cancer Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001716

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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