UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000153 |
|---|---|
| Receipt number | 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 18:01:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
jalsgsc@hama-med.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000222
