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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010855
Receipt No. R000012707
Scientific Title Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.
Date of disclosure of the study information 2013/07/01
Last modified on 2015/06/02

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Basic information
Public title Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.
Acronym Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.
Scientific Title Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.
Scientific Title:Acronym Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.
Region
Japan

Condition
Condition lower risk myelodysplastic syndrome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to evaluate the effectiveness to achieve hematological improvement with azacitidine for lower risk MDS with insufficient hematopoiesis, and to examine the maintenance efficacy of azacitidine maintenance therapy for responsive cases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes This study has two primary endpoints for induction phase and maintenance phase, respectively.
Induction phase: the ratio of cases in which hematological improvement is achieved with 6 course of azacitidine therapy.
Maintenance phase: the ratio of patients who maintained hematological effectiveness achieved in the induction phase after one year with or without azacitidine maintenance therapy.
Key secondary outcomes Induction phase:
Achievement ratio of hematological improvement for each of hematological series.
Cytogenetic response ratio.
Transfusion dependence ratio at the end of induction phase.
Sustainability of induction therapy.
Incidence of Grade 3 side effects or higher.
Incidence of infection that need intravenous antibiotics.
Overall survival ratio.
Progression free survival ratio to AML.

Maintenance phase:
the ratio of patients who maintained hematological effectiveness after two years.
Ratio of AML development.
Ratio of patients who received hematopoietic stem cell transplantation.
Incidence of Grade 3 side effects or higher.
Incidence of infection that need intravenous antibiotics.
Overall survival ratio.
Progression free survival ratio to AML.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In the induction phase, there is no allocation. All the patients receive azacitidine 75mg/m2 for five consecutive days, and 21 days off. Repeat this treatment for six cycles.
In the maintenance phase, those who achieved hematological improvement are allocated randomly into therapy arm and observation arm. In the observation arm, patients halt azacitidine therapy and are followed up periodically (at least once over 3 months for one year after allocation).
Interventions/Control_2 In the therapy arm, patients receive azacitidine 75mg/m2 for 5 consecutive days per 28 days, and repeat this cycle until disease progression.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cases that are diagnosed as MDS according to WHO 2008 criteria. Include therapy related MDS, but does not include MDS/MPN.
2) Cases in low/Int-1 according to IPSS criteria at both diagnostic and enrollment time.
3) Cases with at least one lineage cytopenia. Concretely, at least one of the following criteria are met.
a) Hb<10g/dL and required RBC transfusions in the past 3 months.
b) Plt<50000/mm3 or with bleeding tendency.
c) Neu<1000/mm3 or with increased susceptibility to infection that require antibiotics.
4) Cases with expected life expectancy>1 year.
5) Aged 20 or older.
6) ECOG Performance Status 0~2
7) Cases with total bilirubin and serum creatinine level below 1.5xULN.
8) Cases with AST(GOT) or ALT(GPT) level below 3.0xULN.
9) Cases who can visit hospitals at the pre-defined schedule.
10) Cases with written informed consent.
Key exclusion criteria 1) Cases with scheduled hematopoietic stem cell transplantation. We do not exclude patients who are judged as transplant candidate after entry of this study because of change of medical conditions.
2) Cases who received hematopoietic stem cell transplantation.
3) Cases who had already been enrolled into other clinical trials for MDS.
4) Cases with pregnancy, possibility of pregnancy, in breast-feeding, or with plant to bear a child
5) Cases with hypersensitivity to azacitidine.
6) Cases with other cancers than MDS that is invasive within 5 years.
7) Cases with complicating diseases that are severe or uncontrolled.
8) Cases with psychiatric diseases or psychiatric symptoms that preclude adequate entry to the study.
9) Cases with cognitive disorders.
10) Patients who are receiving successful treatment with other modalities, or who are expected to achieve better response with other treatments (such as with 5q- syndrome).
11) Cases that are considered to be inadequate to enroll this study by the attending physicians.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhito Nannya
Organization The University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address Hongo, 7-3-1, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Email ynanya-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhito Nannya
Organization The University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address Hongo, 7-3-1, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Homepage URL
Email ynanya-tky@umin.ac.jp

Sponsor
Institute National Research Group on Idiopathic Bone Marrow Failure Syndromes
Institute
Department

Funding Source
Organization Grants from the Ministry of Health, Labor and Welfare of Japan
National Research Group on Idiopathic Bone Marrow Failure Syndromes
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
2013 Year 07 Month 01 Day

Related information
URL releasing protocol
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 Terminated
Date of protocol fixation
2013 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 02 Day
Last modified on
2015 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012707

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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