- A second course of induction chemotherapy can be given to the patient when a partial
remission but less than a complete remission is achieved after the first course. At
least 4 weeks should be apart between start of the first course and start of the second
course.
- G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of
hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute
neutrophil counts are 1,000/l or more.
- For the patients who achieve a complete remission, consolidation therapy will be given
as follows:
- Two more cycles of the same chemotherapy will be given to the patients who achieve
a complete remission after single induction course. Allogeneic or autologous
hematopoietic cell transplantation could be also considered.
- In patients who relapse after allogeneic hematopoietic cell transplantation, donor
leukocyte infusion will be done without consolidation chemotherapy.
- In patients who had extramedullary relapse(s), local radiotherapy can be given to
the relapse site(s).
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate, duration of complete remission, toxicities
Hawk Kim, professor
Principal Investigator
Ulsan University Hospital, ROK
Korea: Food and Drug Administration
C-008
NCT00529880
December 2004
October 2007
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