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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004935
Receipt No. R000005876
Scientific Title Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR)
Date of disclosure of the study information 2011/01/24
Last modified on 2018/11/07

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Basic information
Public title Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR)
Acronym Multi-center clinical study to investigate the CMR ratio among CML-CP patients with MMR according to international scale
Scientific Title Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR)
Scientific Title:Acronym Multi-center clinical study to investigate the CMR ratio among CML-CP patients with MMR according to international scale
Region
Japan

Condition
Condition Chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase (CML-CP) who achieved Major Molecular Response (MMR).
Basic objectives2 Others
Basic objectives -Others To compare in-house PCR assay with international scale
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of patients who achieved CMR (<= 0.0032%) in MMR patients, defined by major BCR-ABL mRNA quantitative PCR assay (international scale)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) CML-CP patients under imatinib treatment
2) Patients with MMR* result within 3 months prior to the registration
*<50 copies/assay in high sensitivity Amp-CML assay<100 copies/microg RNA (adjusted by GAPDH) or <0.1%(international scale) in RQ-PCR assay
3) 16 years old or older
4) Patients who gave written informed consent (by both a patient and a legal representative if a patient is minor)
Key exclusion criteria 1) CML patients under treatment with combination therapy with medication other than imatinib
2) CML patients with history of treatment with tyrosine kinase inhibitor other than imatinib
3) Patients with history of hematopoietic stem cell transplantation
4) Patients with severe or uncontrollable complications
5)Patients whom a study physician judges not suitable for participation in the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Miyazaki
Organization Nagasaki University School of Medicine
Division name Hematology, Atomic Disease Institute
Zip code
Address 1-7-1 Sakamoto Nagasaki, Nagasaki 852-8501 Japan
TEL 095-819-7111
Email y-miyaza@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Takahashi
Organization Akita University School of Medicine
Division name Hematology, Oncology, Nephrology, and Rheumatology
Zip code
Address 1-1-1 Hondo, Akita 010-8543 Japan
TEL 018-843-1111
Homepage URL
Email naotot@doc.med.akita-u.ac.jp

Sponsor
Institute CMR Study Group
Institute
Department

Funding Source
Organization Non profit foundation Tohoku Hematology Expert Meeting
Organization
Division
Category of Funding Organization Non profit foundation
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
2011 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.haematologica.org/content/98/9/1407.long
Number of participants that the trial has enrolled
Results
CMR was observed in 75/152 patients (49.3%). 
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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In the univariate analysis, Sokal score, median time to MMR, ABCG2 421C>A, and regulatory T cells were significantly lower in CP-CML patients with CMR than in those without CMR. In the multivariate analysis, duration of imatinib treatment (odds ratio: 1.0287, P=0.0003), time to MMR from imatinib therapy (odds ratio: 0.9652, P=0.0020), and ABCG2 421C/C genotype (odds ratio: 0.3953, P=0.0284) were independent predictors of CMR. In contrast, number of NK cells, BIM deletion polymorphisms, and plasma trough imatinib concentration were not significantly associated with achieving a CMR.

Management information
Registered date
2011 Year 01 Month 24 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005876

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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