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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002838
Receipt No. R000003467
Scientific Title Phase 2 study of the treatment discontinuation after the change from imatinib to Interferon-alpha in chronoic myeloid leukemia patients who maintained major molecular remission.
Date of disclosure of the study information 2009/12/22
Last modified on 2015/07/03

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Basic information
Public title Phase 2 study of the treatment discontinuation after the change from imatinib to Interferon-alpha in chronoic myeloid leukemia patients who maintained major molecular remission.
Acronym JISAS
(Japanese Imatinib Stop And Interferon Study)
Scientific Title Phase 2 study of the treatment discontinuation after the change from imatinib to Interferon-alpha in chronoic myeloid leukemia patients who maintained major molecular remission.
Scientific Title:Acronym JISAS
(Japanese Imatinib Stop And Interferon Study)
Region
Japan

Condition
Condition Chronic myeloid leukemia in 1st chronic phase and major molecular response sustained for more than 2 years with imatinib
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The first purpose is to confirm the finding that Interferon-alhpa is able to maintain major molecular remission (MMR) induced by imatinib after its discontinuation in Philadelphia chromosome positive chronic myeloid leukemia patients who maintained MMR for more than 2 years with imatinib. The second purpose is to clarify whether the MMR is sustained after the stop of the Interferon-alpha therapy afterwards.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Among evaluable patients, the ratio of patients who maintained MMR 12 months after stop of IFN.
Key secondary outcomes

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 Administration of IFN is started at a dose of 3 million units 2-5 times per week within 4 weeks after discontinuation of imatinib treatment. Then, after sustained MMR by IFN for 2 years, IFN treatment is ceased.
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with Philadelphia chromosome-positive or bcr-abl fusion transcript-positive CML 1st chronic phase in CMR under imatinib.
2) MMR maintained for longer than 2 years under imatinib.
3) ECOG Performance status 0,1,2
4) Adequate end organ function as defined by:
i) ALT and AST < 2.5 X ULN (upper limit of normal)
ii) T.Bil < 1.5 X ULN
iii) Cr < 1.5 x ULN
iv) SpO2 under room air = or >95%
5) Ability to provide written informed consent prior to any study procedures being performed.
Key exclusion criteria 1) Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
2) Patients with uncontrolled active infection.
3) Patients with suspicion of interstitial pneumonitis.
4) History of depression.
5) Patients with uncontrolled diabetes.
6) Patients who currently receiving systemic treatment with corticoid or immunosuppressive drugs.
7) Patients whose physicians consider not appropriate.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Usuki
Organization NTT Kanto Medical Center
Division name Division of Hematology
Zip code
Address Higasigotanda, 5-9-22, Shinagawa-ku,Tokyo, Japan Zip code 141-8625
TEL 03-3448-6111
Email kensuke.usuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Usuki
Organization NTT Kanto Medical Center
Division name Division of Hematology
Zip code
Address Higasigotanda, 5-9-22, Shinagawa-ku,Tokyo, Japan Zip code 141-8625
TEL 03-3448-6111
Homepage URL
Email kensuke.usuki@gmail.com

Sponsor
Institute Kanto CML collaborative study group
Institute
Department

Funding Source
Organization Kanto CML collaborative study group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2009 Year 12 Month 22 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
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
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2015 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003467

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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