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
- Conditions
- Chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000027904
- Lead Sponsor
- Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 0
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who achieved deep molecular response during the treatment period
- Secondary Outcome Measures
Name Time Method 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