UMIN-CTR Clinical Trial

Public title

A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase

Acronym

Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)

Scientific Title

A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase

Scientific Title:Acronym

Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)

Region

Japan

Condition

Chronic myelogenous leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the safety and efficacy of Nilotinib in patients with imatinib-resistant or intolerant CML-CP

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

To evaluate the rate of patients with a dose of 800 mg/day at 12 months after starting nilotinib therapy.

Key secondary outcomes

1) To evaluate the response rates at 6 and 12 months of nilotinib therapy.
2) To evaluate the response rates in imatinib-intolerant patients switched to nilotinib therapy at 6 and 12 months after starting imatinib therapy.
3) To evaluate the percentage of patients complying with the protocol treatment by the optimal dose levels at 6 and 12 months of nilotinib therapy.
4) To evaluate the safety of nilotinib
5) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 2 years.

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 administered twice daily at a dose of 400 mg (800 mg/day) for 1 year.

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) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP.
2) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib.
3) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance.
4) ECOG performance status of 0-2.
5) Adequate end organ function.
6) Written informed concent prior to any study procedures being performed.

Key exclusion criteria

1) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry.
2) Patients who are receiving treatment with other investigational agents.
3) Patients who exhibit the T315I BCR-ABL mutation.
4) Patients who have any cardiac disturbances.
5) Severe medical conditions.
6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
7) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Kizaki

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Hematology, Department of Internal Medicine

Zip code

Address

1981 Kamoda, Kawagoe, Saitama 350-8550, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Masahiro Kizaki

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Hematology, Department of Internal Medicine

Zip code

Address

TEL

Homepage URL

Email

makizaki@saitama-med.ac.jp

Institute

Tokyo STI Study Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

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

2009

Year

05

Month

01

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

Date of protocol fixation

2009

Year

02

Month

27

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

05

Month

01

Day

Last modified on

2009

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002325