UMIN-CTR Clinical Trial

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
Email	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
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	Clinical Research Center in Hiroshima
Address	Kasumi 1-2-3, Minamiku, Hiroshima
Tel	082-257-1752
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031946