UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003016
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Osaka CML-MRD Meeting
Institute
Department

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
URL(English) https://upload.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


Contact us.