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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000153
Receipt No. R000000222
Scientific Title Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Date of disclosure of the study information 2005/09/10
Last modified on 2016/01/05

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Basic information
Public title Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Acronym Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Scientific Title Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Scientific Title:Acronym Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Region
Japan

Condition
Condition Previously untreated chronic-phase chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objectives are to test the efficacy of imatinib monotherapy in patients with newly diagnosed chronic-phase CML, to test whether combining imatinib with IFN or cytarabine ocfosfate overcome the resistance of imatinib and to estimate the frequency and severity of toxicities (randomized phase II)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1) Imatinib monotherapy: overall survival
2) Combination therapy: cytogenetic response at 9 months
Key secondary outcomes 1) Imatinib monotherapy: toxicity, hematologic response at 6 months, cytogenetic response at 9 months, progression free survival, time to treatment failure
2) Combination therapy: toxicity, hematologic response, cytogenetic response, overall survival, progression free survival, time to treatment failure

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Imatinib
Interventions/Control_2 Imatinib+Interferon-alpha
Interventions/Control_3 Imatinib+Cytarabine ocfosfate
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Chronic phase CML (Ph+ or BCR-ABL+) previously untreated with IFN
2. Age: 15=<
3. PS 0-3 (ECOG)
4. No severe organ dysfunction
5. Written informed consent
Key exclusion criteria 1. Other active neoplasms
2. Severe comorbidity
3. Hypersensitivity to imatinib
4. Previously treated with IFN
5. Psychological disorders
6. Pregnant and/or lactating woman
7. CML in accelerated phase or blast crisis
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Ohnishi
Organization Hamamatsu University School of Medicine
Division name Division of Clinical Oncology
Zip code
Address 1-20-1, Handayama, Higashi-ku,Hamamatsu, 431-3192, Japan
TEL 053-433-4993
Email kohnishi@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Ohnishi
Organization JALSG CML202 Study Office
Division name Hamamatsu University School of Medicine, Division of Clinical Oncology
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL 053-433-4993
Homepage URL http://miwa.hama-med.ac.jp/jalsg/
Email jalsgsc@hama-med.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
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 09 Month 10 Day

Related information
URL releasing protocol http://miwa.hama-med.ac.jp/jalsg/
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.2012.02253.
Number of participants that the trial has enrolled
Results
A prospective multicenter Phase II study was performed to examine the efficacy and safety of imatinib therapy in newly diagnosed Japanese patients with chronic-phase CML. Patients were scheduled to receive imatinib 400 mg daily. Plasma imatinib concentrations were measured by liquid chromatography-tandem mass spectrometry. In 481 evaluable patients, estimated 7-year overall survival (OS) and event-free survival (EFS) at a median follow-up of 65 months were 93% and 87%, respectively. Because imatinib dosage was reduced in many patients due mainly to adverse events, subgroup analysis was performed according to the mean daily dose during the first 24 months of treatment: more than 360 mg or 360 mg (400-mg group; n = 294), 270-359 mg (300-mg group; n = 90) and less than 270 mg (200-mg group; n = 67). There were no significant differences in OS and EFS between the 300- and 400-mg groups; however, cumulative rates of complete cytogenetic and major molecular responses differed significantly between the two groups. There were no significant differences in mean imatinib trough levels between these two groups for the patients in whom trough levels had been measured. Survival and efficacy in the 200-mg group were markedly inferior to the former two groups. These results suggest that, although a daily dose of 400 mg imatinib is associated with better outcomes, 300 mg imatinib may be adequate for a considerable number of Japanese patients who are intolerant to 400 mg imatinib. Blood level monitoring would be useful to determine the optimal dose of imatinib.
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
2002 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2002 Year 04 Month 01 Day
Last follow-up date
2010 Year 05 Month 31 Day
Date of closure to data entry
2010 Year 05 Month 31 Day
Date trial data considered complete
2011 Year 09 Month 22 Day
Date analysis concluded
2012 Year 02 Month 16 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 10 Day
Last modified on
2016 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000222

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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