UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000153
Receipt number R000000222
Scientific Title Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Date of disclosure of the study information 2005/09/10
Last modified on 2016/01/05 18:01:10

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Basic information

Public title

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Acronym

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Scientific Title

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Scientific Title:Acronym

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Region

Japan


Condition

Condition

Previously untreated chronic-phase chronic myelogenous leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objectives are to test the efficacy of imatinib monotherapy in patients with newly diagnosed chronic-phase CML, to test whether combining imatinib with IFN or cytarabine ocfosfate overcome the resistance of imatinib and to estimate the frequency and severity of toxicities (randomized phase II)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1) Imatinib monotherapy: overall survival
2) Combination therapy: cytogenetic response at 9 months

Key secondary outcomes

1) Imatinib monotherapy: toxicity, hematologic response at 6 months, cytogenetic response at 9 months, progression free survival, time to treatment failure
2) Combination therapy: toxicity, hematologic response, cytogenetic response, overall survival, progression free survival, time to treatment failure


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Imatinib

Interventions/Control_2

Imatinib+Interferon-alpha

Interventions/Control_3

Imatinib+Cytarabine ocfosfate

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. Chronic phase CML (Ph+ or BCR-ABL+) previously untreated with IFN
2. Age: 15=<
3. PS 0-3 (ECOG)
4. No severe organ dysfunction
5. Written informed consent

Key exclusion criteria

1. Other active neoplasms
2. Severe comorbidity
3. Hypersensitivity to imatinib
4. Previously treated with IFN
5. Psychological disorders
6. Pregnant and/or lactating woman
7. CML in accelerated phase or blast crisis

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Ohnishi

Organization

Hamamatsu University School of Medicine

Division name

Division of Clinical Oncology

Zip code


Address

1-20-1, Handayama, Higashi-ku,Hamamatsu, 431-3192, Japan

TEL

053-433-4993

Email

kohnishi@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Ohnishi

Organization

JALSG CML202 Study Office

Division name

Hamamatsu University School of Medicine, Division of Clinical Oncology

Zip code


Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan

TEL

053-433-4993

Homepage URL

http://miwa.hama-med.ac.jp/jalsg/

Email

jalsgsc@hama-med.ac.jp


Sponsor or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 10 Day


Related information

URL releasing protocol

http://miwa.hama-med.ac.jp/jalsg/

Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.2012.02253.

Number of participants that the trial has enrolled


Results

A prospective multicenter Phase II study was performed to examine the efficacy and safety of imatinib therapy in newly diagnosed Japanese patients with chronic-phase CML. Patients were scheduled to receive imatinib 400 mg daily. Plasma imatinib concentrations were measured by liquid chromatography-tandem mass spectrometry. In 481 evaluable patients, estimated 7-year overall survival (OS) and event-free survival (EFS) at a median follow-up of 65 months were 93% and 87%, respectively. Because imatinib dosage was reduced in many patients due mainly to adverse events, subgroup analysis was performed according to the mean daily dose during the first 24 months of treatment: more than 360 mg or 360 mg (400-mg group; n = 294), 270-359 mg (300-mg group; n = 90) and less than 270 mg (200-mg group; n = 67). There were no significant differences in OS and EFS between the 300- and 400-mg groups; however, cumulative rates of complete cytogenetic and major molecular responses differed significantly between the two groups. There were no significant differences in mean imatinib trough levels between these two groups for the patients in whom trough levels had been measured. Survival and efficacy in the 200-mg group were markedly inferior to the former two groups. These results suggest that, although a daily dose of 400 mg imatinib is associated with better outcomes, 300 mg imatinib may be adequate for a considerable number of Japanese patients who are intolerant to 400 mg imatinib. Blood level monitoring would be useful to determine the optimal dose of imatinib.

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

Completed

Date of protocol fixation

2002 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2002 Year 04 Month 01 Day

Last follow-up date

2010 Year 05 Month 31 Day

Date of closure to data entry

2010 Year 05 Month 31 Day

Date trial data considered complete

2011 Year 09 Month 22 Day

Date analysis concluded

2012 Year 02 Month 16 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 10 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=R000000222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name