Granulocyte Colony Stimulating Factor (G-CSF) After Salvage Chemotherapy in Refractory AML

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul St. Mary's Hospital
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0~2

• AML with remission failure after standard chemotherapy

• Stable liver and renal function (=< Upper normal limit (UNL) x 2.5)

• Stable heart and lung function (Ejection Fraction (EF) > 45%, Forced expiratory volume at one second (FEV1) > 40%)

Exclusion Criteria:

• Acute promyelocytic leukemia

• Central nervous system (CNS) involvement

• Uncontrolled bleeding

• Uncontrolled infectious complication

• Pregnancy, Breast feeding

• Significant cardiovascular disease within 6 months

• Significant organ failure (> UNL x 2.5)