UMIN-CTR Clinical Trial

Public title

Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) with nilotinib treatment, among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR) with imatinib treatment.

Acronym

Multi-center clinical study to investigate the ratio of CMR with nilotinib treatment, among CML-CP patients with MMR.

Scientific Title

Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) with nilotinib treatment, among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR) with imatinib treatment.

Scientific Title:Acronym

Multi-center clinical study to investigate the ratio of CMR with nilotinib treatment, among CML-CP patients with MMR.

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 cumulative CMR rate by 18 months after the initiation of nilotinib treatment in patients with Philadelphia chromosome positive CML-CP, among patients who have received imatinib for 18 month or longer and achieved a MMR but with not achieved a CMR(BCR-ABL/ABL ratio<=0.0032%).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

The cumulative CMR rate by 18 months after the initiation of nilotinib treatment

Key secondary outcomes

* The cumulative CMR rate by 24 months after the initiation of nilotinib treatment.
* Percentage of patients maintaining CMR at 24 month after the initiation of nilotinib treatment.
* Overall survival (OS) at 24 months after the initiation of nilotinib treatment.
* Relapse-free survival (RFS) at 24 months after the initiation of nilotinib treatment.
* Safety of nilotinib.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

nilotinib will be orally administered with 300 mg twice daily approximately 12 hours apart, at least one hour before meals or at least 2 hours after meals.
Nilotinib are taken for 2 years.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Men and women aged 18 and over.
2. Patients with an ECOG performance status of 0-2.
3. Patients who have received imatinib treatment at least 18 months and who have achieved MMR, but not achieved CMR.
4. Patient who meets the following criteria for laboratory tests.
a.T.Bill < 1.5 X ULN
b.AST and ALT < 2.5 X ULN
c. Cre 1.5 < 1.5 X ULN
d. AMY and Lipase <= 1.5 X ULN
e. ALP <= 2.5 X ULN
f. Serum K and Mg, P, Ca >= LLN/ >=LLN in the adjuvant treatment before the first dose of nilotinib
5. Patient who gave written informed consent before starting the screening test.

Key exclusion criteria

1. Patients with history of accelerated phase(AP) or blastic crisis(BC)-CML .
2. Patient with history ofT315I point mutation of BCR-ABL.
3. Patient with history of treatment with TKI other than imatinib.
4. Patient who has any cardiac disturbances including the following conditions.
a. Complete left bundle branch block
b. Congenital long QT syndrome or family history of long QT syndrome
c. History or complication of serious ventricular or atrial tachycardia
d.Clinically serious resting bradycardia
e.QTc>450 msec by electrocardiography
f. Use of a ventricular pacemaker
g.History of Myocardial infarction within 12 months before start of study
h.Other heart disease with clinically significant.
5. Patients have been administered the drug can prolong the QT interval.
6. Patient who has any gastrointestinal disorders or diseases which may affect the absorption of the study drug.
7. Patients who has a history of acute or chronic pancreatitis within one year.
8. Patient who has CNS involvement of leukemic cells
9. Cancer patients with a duplication of activity.
10. Patients with complications such as severe or uncontrolled.
11. Patients with a history of congenital or acquired serious bleeding disorders not associated with leukemia.
12. History of major surgery within 4 weeks before start of study
13. Patients treated with other investigational drugs within 28 days before the start of administration of nilotinib.
14. Patients with a history of non-compliance with medication.
15. Patient who is pregnant or nursing women.
16. Patients who are participating in any other clinical trial include observation trial.

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Koichi MIYAMURA

Organization

Japanese Red Cross Nagoya First Hospital

Division name

Division of Hematology

Zip code

Address

3-35,Michishita-cho,Nakamura-ku,Nagoya 453-0046,Japan

TEL

052-481-5111

Email

miyamu@nagoya-1st.jrc.or.jp

Name of contact person

1st name
Middle name
Last name	Yukiyasu OZAWA

Organization

Japanese Red Cross Nagoya First Hospital

Division name

Division of Hematology

Zip code

Address

-35,Michishita-cho,Nakamura-ku,Nagoya 453-0046,Japan

TEL

052-481-5111

Homepage URL

http://www.c-shot.or.jp/

Email

ozaway@nagoya-1st.jrc.or.jp

Institute

Japanese Red Cross Nagoya First Hospital

Institute

Department

Personal name

Organization

Center for Supporting Hematology-Oncology Trials

Organization

Division

Category of Funding Organization

Non profit foundation

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

愛知県がんセンター中央病院（愛知県）、安城更生病院（愛知県）、岐阜大学医学部附属病院（岐阜県）、江南厚生病院（愛知県）、豊橋市民病院（愛知県）、名古屋医療センター（愛知県）、名古屋第一赤十字病院（愛知県）、名古屋大学医学部附属病院（愛知県）、藤田保健衛生大学病院（愛知県）

Date of disclosure of the study information

2012

Year

04

Month

17

Day

URL releasing protocol

http://www.c-shot.or.jp/

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

Terminated

Date of protocol fixation

2012

Year

04

Month

02

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2016

Year

03

Month

31

Day

Date analysis concluded

Other related information

Registered date

2012

Year

04

Month

17

Day

Last modified on

2016

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009099