UMIN-CTR Clinical Trial

Public title

The Observational Study of Chronic Myeloid Leukemia Patients in Chronic Phase with Resistance or Intolerance to Preceding TKI in Japan

Acronym

The New Target Observational Study 2

Scientific Title

The Observational Study of Chronic Myeloid Leukemia Patients in Chronic Phase with Resistance or Intolerance to Preceding TKI in Japan

Scientific Title:Acronym

The New Target Observational Study 2

Region

Japan

Condition

Chronic Myeloid Leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The primary objective of this observational study is to prospectively follow up chronic phase chronic myeloid leukemia (CML-CP) patients with resistant or intolerant to the preceding tyrosine kinase inhibitor (TKI) and thus to obtain the overview of treatment responses and outcomes in this patient population in Japan. Additionally, minimal residual disease (major Bcr-Abl chimera mRNA) will be measured on the International Scale (IS) by quantitative realtime PCR (QRT-PCR) and compared with overseas data. Also, the prognostic values of Sokal score (Sokal score at diagnosis is a known prognostic factor), plasma imatinib level, and Bcr-Abl gene mutations for survival outcomes by treatment will be assessed.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival (OS) rate at 3 years after the start of 2nd-line or subsequent treatment.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)CML-CP patients with none of the following signs of accelerated or blast phase CML:
- Blasts more than 15% of peripheral blood white cells or bone marrow cells
- Combined blast/promyelocyte count more than 30% in peripheral blood or bone marrow
- Peripheral blood basophiles more than 20%
- Extramedullary lesions other than hepato-splenomegaly
2)Patients who have given written informed consent to the study; informed consent must also be obtained from the legal representative of every patient under 20 years of age.
3)Patients who will be able to make visits to a study site as scheduled.

Key exclusion criteria

1)Patients previously treated with any investigational drug for CML.
2)Women with confirmed or potential pregnancy, nursing mothers, and male or female patients who wish to have a child during the study period.
3)Patients with a history of allergy to imatinib, nilotinib or dasatinib.
4)Patients with any concomitant illness that contraindicates use of imatinib, nilotinib or dasatinib.
5)Patients with any other condition that, in the investigator's opinion, disqualifies them for inclusion in the study.

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Tomoki Naoe

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Hematology and Oncology

Zip code

Address

65 Tsurumai-Cho, Showa-Ku, Nagoya, 466-8550, Japan

TEL

052-744-2136

Email

Name of contact person

1st name
Middle name
Last name	Itaru Matsumura

Organization

Kinki University School of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code

Address

377-2 Ohno-Higashi, Osaka-Sayama 589-8511, Japan

TEL

072-366-0221

Homepage URL

Email

Institute

The Japanese Society of Hematology

Institute

Department

Personal name

Organization

The Japanese Society of Hematology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2010

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2010

Year

01

Month

05

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This will be a multicenter, prospective, non-intervention observational (cohort) study involving previously treated CML-CP patients who have developed any Event ("Failure", "Suboptimal Response" or "Intolerance") on the preceding TKI (imatinib, nilotinib or dasatinib) and who are to be switched to escalated-dose imatinib or any second-generation TKI (nilotinib or dasatinib).
The prognostic values of Sokal score (Sokal score at diagnosis is a known prognostic factor), plasma imatinib level, and BCR-ABL gene mutations for survival outcomes by treatment will be assessed.
To minimize site-related biases, the investigators should make every effort to consecutively enroll consenting patients.

Registered date

2010

Year

05

Month

08

Day

Last modified on

2013

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004342