UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003016
Receipt number R000003659
Scientific Title Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.
Date of disclosure of the study information 2010/02/01
Last modified on 2012/04/17 15:08:15

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Basic information

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

Condition

Chronic myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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



Public contact

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



Sponsor or person

Institute

Osaka CML-MRD Meeting

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪府、兵庫県


Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name