UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027904 |
|---|---|
| Receipt number | 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 | 2021/07/01 19:35:06 |
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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 | Tatsuo |
| Middle name | |
| Last name | Ichinohe |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University.
Division name
Department of Hematology and Oncology
Zip code
734-8553
Address
Kasumi 1-2-3, minamiku, Hiroshima, Hiroshima
TEL
082-257-5861
tatsuo.ichinohe@gmail.com
Public contact
Name of contact person
| 1st name | Noriyasu |
| Middle name | |
| Last name | Fukushima |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University.
Division name
Department of Hematology and Oncology
Zip code
734-8553
Address
Kasumi 1-2-3, minamiku, Hiroshima, Hiroshima
TEL
082-257-5861
Homepage URL
fukushin@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University.
Institute
Department
Personal name
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
Clinical Research Center in Hiroshima
Address
Kasumi 1-2-3, Minamiku, Hiroshima
Tel
082-257-1752
protocol@cimr.hiroshima-u.ac.jp
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
0
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
| 2017 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 28 | Day |
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
| 2021 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031946
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| Registered date | File name |
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