Leukemia, Myeloid, Acute Clinical Trial
Official title:
The DEtection of G-CSF REceptor With Flow Cytometry and Identification of the Effect of G-CSF After Salvage Chemotherapy in Relapsed or Refractory AML
Granulocyte Colony Stimulating Factor (G-CSF, filgrastim) is now widely used after
chemotherapy which complicates hematological toxicity involving neutropenia. As prolonged
neutropenia leads to neutropenic fever due to bacteremia or fungal infection, the use of
G-CSF prevents severe infectious complication in various cancer patients.
In acute myeloid leukemia (AML), leukemic blasts have been expected to have G-CSF receptor
which may be stimulated by G-CSF, and refractory patients were not treated with G-CSF in
salvage chemotherapy in Catholic blood and marrow transplantation (BMT) Center for a long
time. This strategy induced prolonged neutropenia and a lot of infectious complications some
of which led to deaths.
Although there are some data which remind us G-CSF may proliferate leukemic blasts, the
investigators also identified several reports which suggested that subgroup with G-CSF use
showed acceptable CR rate and improved survival outcomes compared to a subgroup without
G-CSF use.
Therefore investigators are now trying to identify the effects of G-CSF for refractory AML
patients in salvage chemotherapy setting regarding the duration of neutropenia and
admission, incidence of infectious complications and the duration of antibiotics
application. Furthermore, overall response rate (CR+CRi) after salvage chemotherapy and
survival outcomes will be calculated according to G-CSF use.
Also, investigators will detect G-CSF receptor using cluster of differentiation 114 (CD114),
and analyze the clinical outcomes according to the subgroups with or without using G-CSF
during neutropenic period.
Patients will be treated with mitoxantrone and etoposide and cytarabine. Patients will be
randomly divided according to the usage of G-CSF.
Subgroup with G-CSF will be treated with G-CSF after 7~10 days post-chemotherapy, when
blasts will disappear from peripheral blood.
Subgroup without G-CSF will be observed until 25~28 days post-chemotherapy. If blood counts
are nor recovered, the investigators can perform bone marrow biopsy to identify the status
of the bone marrow.
After then, G-CSF can be applied if blasts are not observed in both peripheral blood and
bone marrow.
When absolute neutrophil counts are recovered and there are no evidence of infectious
complications, patients will discharge safely from hospital.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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