UMIN-CTR Clinical Trial

Public title

Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.

Acronym

Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.

Scientific Title

Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.

Scientific Title:Acronym

Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.

Region

Japan

Condition

Chronic myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To confirm molecular response, which indicators are Major Molecular Response (MMR) and/or Complete Molecular Response (CMR) rate, of Nilotinib at 12 months treatment for CML patients with Imatinib resistant including suboptimal response or intolerant.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Molecular response rate at 12 months treatment by Nilotinib 400mg bid

Key secondary outcomes

1) Complete hematologic response (CHR) rate at 3,6,12,18,24 months treatment by Nilotinib
2) Cytogenetic response (CyR) rate at 3,6,12,18,24 months treatment by Nilotinib
3) Molecular response at 3,6,18,24 months treatment by Nilotinib
4) Progression Free survival at 24 months treatment by Nilotinib
5) Review of safety (category, grade and frequency of adverse events based on Nilotinib)
6) Correlation between term from diagnostic confirmation of CML to beginning Nilotinib treatment and Nilotinib efficacy (Cytogenetic response / Molecular genetic response)
7) Comparison of Nilotinib efficacy for Imatinib resistant patients with those for Imatinib intolerant patients at 12 or 24 months treatment by Nilotinib
8) Correlation between BCR/ABL poin-mutaion to molecular response

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 is administered 400mg(2cap) bid ruled intake 1hr before or 2 hrs after a meal

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

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Philadelphia positive CML patients with chronic phase
2)Imatinib resistant or Intolerant patients
3) age >= 15 years old
4) Performance Status (ECOG) 0-2
5) Keeping major organ function and filling following condition;
-Neutrophil: >= 1,000 / cubic millimeter
-Platelet: >= 50,000 / cubic millimeter
-Hb: > = 8.0 g /dL
-sCr: < = 3.0 times Upper Limit Normal of each establishment(ULN)
-s-bilirubin: < = 3 times ULN
-AST(GOT) / ALT(GOT):< = 5 times ULN
-Lipase: < = 2 times ULN
6) Patient who can visit his study site routinely
7) Taking agreement by document from patient himself (in a case which patient is less than 20 years old, both patient and his/her stake holder) regarding participation for this clinical study

Key exclusion criteria

1) accelerating phase(AP) patients with following one or more condition or suspected blast phase (BC) patients
AP:
-blast rate >= 15% in peripheral blood or bone marrow, and < 30% in both peripheral blood and bone marrow
-blast + promyelocyte : >= 30% in peripheral blood or bone marrow
-basophil rate: >= 20% in peripheral blood
-platelet: continuous decline on treatment independently (<= 10,000 / cubic millimeter)
BC:
-blast: >= 30% in peripheral blood or bone marrow
-No blast increase extramedullary except hepatosplenomegaly proven by biopsy
2) No drug history of Hydrea or IFN-alpha as CML treatment
3) Class 3, 4 in NYHA
4) Double invasive cancer within 5 years before beginning of Nilotinib
5) Uncontrollable disease complication
6) Diagnosed HIV
7) patients during pregnancy or possible in pregnancy
8) Patients during lactation or expecting pregnancytients
9) Patients with psychiatric disease or psychological symptom

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Yuzuru Kanakura

Organization

Osaka University Graduate School of Medicine

Division name

Department of Hematology/Oncology

Zip code

Address

2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.

TEL

06-6879-5111

Email

Name of contact person

1st name
Middle name
Last name	Itaru Mtsumura

Organization

Osaka University Graduate School of Medicine

Division name

Department of Hematology/Oncology,

Zip code

Address

2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.

TEL

06-6879-5111

Homepage URL

Email

Institute

Osaka CML-MRD Meeting

Institute

Department

Personal name

Organization

None

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

大阪府、兵庫県

Date of disclosure of the study information

2010

Year

02

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

No longer recruiting

Date of protocol fixation

2009

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2009

Year

07

Month

01

Day

Last follow-up date

2011

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

01

Month

12

Day

Last modified on

2012

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003659