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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027904
Receipt No. R000031946
Scientific Title A proof-of-concept clinical trial to evaluate the efficacy and safety of combined use of cefadroxil and tyrosine kinase inhibitors in minimal residual disease-positive patients with chronic phase chronic myelogenous leukemia
Date of disclosure of the study information 2017/07/15
Last modified on 2019/03/07

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Basic information
Public title A proof-of-concept clinical trial to evaluate the efficacy and safety of combined use of cefadroxil and tyrosine kinase inhibitors in minimal residual disease-positive patients with chronic phase chronic myelogenous leukemia
Acronym The efficacy and safety of TKI combined CDX for CML-CP
Scientific Title A proof-of-concept clinical trial to evaluate the efficacy and safety of combined use of cefadroxil and tyrosine kinase inhibitors in minimal residual disease-positive patients with chronic phase chronic myelogenous leukemia
Scientific Title:Acronym The efficacy and safety of TKI combined CDX for CML-CP
Region
Japan

Condition
Condition Chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of cefadroxil combined with tyrosine kinase inhibitors in patients with chronic-phase chronic myeloid leukemia who attained optimal response (MR3.0) but did not achieve deep molecular response (MR4.5)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Proportion of patients who achieved deep molecular response during the treatment period
Key secondary outcomes 1) Adverse events
2) The temporal changes of BCR-ABL mRNA levels in bone marrow CD34+CD38- cells
3) PK/PD of CDX and TKI

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 Patients received CDX (at an oral dose of 1500 mg per day) with TKI which they have already taken (1 course). This regimen is repeated three times.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) CML-CP achieves MR 3.0, but not MR 4.0
(eligible fisrt and later second chronic phase
(2) ECOG performance status 0-1
(3) more than 20 years old
(4) outpatient
(5) Patients from whom informed consent has been obtained using documents.
Key exclusion criteria (1) History of shock against CDX
(2) Infectious mononucleosis
(3) Hypersensitivity against cephalosporin and penicillin antimicrobial agents
(4) Renal insufficiency (CCr;less than 50ml/min.)
(5) Difficulty of oral intake and receiving the parental nutrition
(6) History of receiving stem cell transplantation
(7) Cardiac dysfunction (necessary of medication for arrhythmia, ischemic cardiac disease, heart failure and cardiomyopathy)
(8) Pregnancy, nursing or possibly pregnant women
(9) Attempt to get the child and no will of contraception
(10) Patients received cephalosporin within twelve weeks ago before this trial
(11) Patients participated other trail study and took trial drugs.
(12) No indication for this study as judged by physicians in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Ichinohe
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University.
Division name Department of Hematology and Oncology
Zip code
Address Kasumi 1-2-3, minamiku, Hiroshima, Hiroshima
TEL 082-257-5861
Email tatsuo.ichinohe@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Noriyasu Fukushima
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University.
Division name Department of Hematology and Oncology
Zip code
Address Kasumi 1-2-3, minamiku, Hiroshima, Hiroshima
TEL 082-257-5861
Homepage URL
Email fukushin@hiroshima-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University.
Institute
Department

Funding Source
Organization Nothing
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 広島大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 15 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 06 Month 23 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031946

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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