UMIN-CTR Clinical Trial

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

Chronic myelogenous leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

CMR Study Group

Institute

Department

Personal name

Organization

Non profit foundation Tohoku Hematology Expert Meeting

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2011

Year

01

Month

24

Day

Last modified on

2018

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005876