UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005462 |
|---|---|
| Receipt number | R000006479 |
| Scientific Title | Efficacy of Imatinib with Early Dose Titration Targeting Optimal Blood Trough Levels in Patients with Chronic Myeloid Leukemia in Early Chronic Phase: A Phase II Study |
| Date of disclosure of the study information | 2011/04/22 |
| Last modified on | 2012/04/18 12:45:52 |
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Basic information
Public title
Efficacy of Imatinib with Early Dose Titration Targeting Optimal Blood Trough Levels in Patients with Chronic Myeloid Leukemia in Early Chronic Phase: A Phase II Study
Acronym
Clinical Study Evaluating the Efficacy of Imatinib with Early Dose adjustment for Optimal Blood Trough Levels in Patients with CML-early CP
Scientific Title
Efficacy of Imatinib with Early Dose Titration Targeting Optimal Blood Trough Levels in Patients with Chronic Myeloid Leukemia in Early Chronic Phase: A Phase II Study
Scientific Title:Acronym
Clinical Study Evaluating the Efficacy of Imatinib with Early Dose adjustment for Optimal Blood Trough Levels in Patients with CML-early CP
Region
| Japan |
Condition
Condition
Chronic Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study is designed to confirm a substantial increase of blood trough level of imatinib and to evaluate its efficacy after early dose titration targeting optimal trough in patients with CML in early CP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Change in trough of imatinib after up-titration (proportion of subjects achieving an optimal trough level).
Key secondary outcomes
Proportions of subjects achieving MMR and CCyR at 3, 6, 12 and 18 months after up-titration to 600 mg/day, safety of imatinib at 600 mg/day, proportion of subjects continuing treatment at 600 mg/day, and overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) rates at 18 months after enrollment.
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
Imatinib will be administered for 18 months at 400 mg (4 tablets) or 600 mg (6 tablets) once daily. If the optimal trough (>=1,002 ng/mL) is not attained at baseline, the dose will be promptly up-titrated to 600 mg/day. If the optimal trough is attained at baseline, treatment with imatinib will be continued at 400 mg/day.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with CML-CP1 proven to be Ph chromosome positive at the first diagnosis.
2)Patients having been treated with imatinib for a duration of >=2 and <6 months.
3)Patients treated with imatinib at 400 mg/day during the month immediately before enrollment.
4)Patients receiving imatinib once daily and available for blood collection at 24 hours after a previous dose (immediately before dosing).
5)Patients with ECOG performance status (PS) 0-2.
6)Patients with a serum bilirubin or creatinine level not exceeding 3 times the upper limit of normal (ULN).
7)Patients with a serum AST (GOT) or ALT (GPT) level not exceeding 5 times the ULN.
8)Patients who will be able to make visits to a study site as scheduled.
9)Patients who have given written informed consent to the study; informed consent must also be obtained from the legal representative of every patient under 20 years of age.
Key exclusion criteria
1)Failure to achieve complete hematologic response (CHR) at 3 months after the start of imatinib therapy.
2)Loss of CHR or complete cytogenetic response (CCyR) once achieved at any time after the start of imatinib therapy.
3)Development of any Bcr-Abl gene mutation that confers decreased sensitivity to imatinib.
4)Appearance of additive chromosomal aberration in a Ph chromosome positive cell at any time after the start of imatinib therapy.
5)Presence of the Bcr-Abl point mutation T351I.
6)Previous treatment with any investigational drug for CML.
7)Previous treatment with IFN-alpha.
8)Previous treatment with any oral cytotoxic drug (e.g., hydroxyurea) for at least 3 months.
9)Confirmed or potential pregnancy, current breast-feeding, and wish to have a child during the study period.
10)A history of allergy to imatinib.
11)Any other diffuse malignancy during the 5 years before enrollment.
12)Any serious or uncontrollable concomitant illness.
13)Any concomitant psychotic disorder or psychiatric symptom that, in the investigator's opinion, prevents the patient from participating in the study.
14)Cognitive dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kurokawa |
Organization
The University of Tokyo Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Nannya |
Organization
The University of Tokyo Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
TEL
Homepage URL
ynanya-tky@umin.net
Sponsor or person
Institute
Tokyo CML Conference
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
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
| 2011 | Year | 04 | Month | 22 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 18 | Day |
Last modified on
| 2012 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006479
