chronic myelogenous leukemia
Conditions
Interventions
stop imatinib if CMR is achieved add IFN-alpha if CMR is not achieved
Sponsors
Department of Clinical and Experimental Hematology, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preregistration 1. Patients with CML in 1st chronic phase who achieve CCR, more than 18 months after starting imatinib 2. >20 yrs old 3. Patients who are informed with documents Registration 1. Patients who achieve CMR by Q-PCR and nested PCR, and remain in CMR after 6 months by Q-PCR and nested PCR
Exclusion criteria
Exclusion criteria: 1. Patients in whom other treatments including transplantation are more eligible than this protocol 2. Patients who was previously administrated with IFN-alpha 3. Patients who have a history of allergic reaction to vaccines and other biologicals 4. Patients who were previously administered with Shyosaikoto 5. Patients who have autoimmune hepatitis 6. Patients who are pregnant or who expect to be pregnant during the study period 7. Patients in depression 8. Patients who have cytogenetic abnormalities if Ph chromosome is negative at the registration 9. Patients whose physician in charge judges inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ratio of maintaining CMR 24 months after stopping imatinib | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ratio of maintaining CMR without relapse 24 months after stopping imatinib 2. cumulative ratio of relapse within 24 months after stopping imatinib 3. ratio of CMR achievement within 12 months after stopping IFN-alpha 4. number of adverse events | — |
Countries
Japan
Contacts
Public ContactMamiko Sakata-Yanagimoto
University of Tsukuba Tsukuba University Hospital
Outcome results
None listed