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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000290
Receipt No. R000000369
Scientific Title Phase II study of imatinib mesylate for treatment of Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children: A Japanese Cooperative Trial
Date of disclosure of the study information 2005/12/01
Last modified on 2011/07/06

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Basic information
Public title Phase II study of imatinib mesylate for treatment of Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children: A Japanese Cooperative Trial
Acronym Ph+ ALL04
Scientific Title Phase II study of imatinib mesylate for treatment of Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children: A Japanese Cooperative Trial
Scientific Title:Acronym Ph+ ALL04
Region
Japan

Condition
Condition Philadelphia Chromosome-positive acute lymphoblastic leukemia
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of imatinib mesylate in children with Philadelphia chromosome-positive acute lymphoblastic leukemia in remission using a molecular technique. To evaluate the feasibilty of conductuing allogeneic hematopoietic stem cell transplantation for patients in the first remission.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To determine the efficacy of imatinib mesylate for children with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) assessed by a molecular quantification technique.
Key secondary outcomes To evaluate the event-free survival for patients with Ph+ ALL assessed by a life table analysis, To evaluate the rate of patients who receive allogeneic stem cell transplantation (SCT) in the first complete remission (CR).
To evaluate the safety of the regimen.

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 The effect of imatinib mesylate monotherapy will be assessed using a molecular technique before the hematopoietic stem cell transplantation.
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 Patient with a diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia.
No previous treatment including chemotherapeutic agents and radiotherapy. The use of steroids or intrathecal tehrapy is accepted.
ECOG performance status score should be 0-2.
Adequate end organ function, defined as the following: total bilirubin < 2mg/dl, creatinin < 2mg/dl. Normal EKG.
Patients or legal guardians must sign an informed consent and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Key exclusion criteria Intracranial hemorrhage.
Heart failure requiring treatment.
Chronic renal failure.
Active uncontrolled infections.
Diabetes mellitus.
Liver chirrhosis.
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Female patients who are pregnant or breast-feeding.
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Manabe
Organization St. Luke's International Hospital
Division name Department of Pediatrics,
Zip code
Address 9-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560
TEL 03-3-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Takimoto
Organization JPLSG
Division name Data Center
Zip code
Address National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya
TEL 052-951-1111
Homepage URL http://www.jplsg.jp/
Email jplsgdata@nnh.hosp.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour 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 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
2005 Year 12 Month 01 Day

Related information
URL releasing protocol http://www.jplsg.jp/
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
2004 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information Safety assessments will consist of evaluating adverse events, combining laboratory parameters including hematology and chemistry, vital signs, physical examinations, and documentation of all concomitant medications and/or therapies.

Management information
Registered date
2005 Year 11 Month 24 Day
Last modified on
2011 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000369

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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