Chronic myelogenous leukemia
Conditions
Interventions
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.
Sponsors
Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved deep molecular response during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoriyasu Fukushima
Research Institute for Radiation Biology and Medicine, Hiroshima University. Department of Hematology and Oncology
Outcome results
None listed