UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002838 |
|---|---|
| Receipt number | 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 | 2021/03/28 20:26:20 |
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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
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
kensuke.usuki@gmail.com
Sponsor or person
Institute
Kanto CML collaborative study group
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 27 | Day |
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
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003467
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