UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000290 |
|---|---|
| Receipt number | 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 00:41:49 |
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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
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/
jplsgdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000369
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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