Skip to content

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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427919
Acronym
DeGREE
Enrollment
56
Registered
2015-04-28
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute

Keywords

G-CSF, G-CSF receptor, AML, refractory AML, Neutropenic fever, salvage chemotherapy

Brief 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.

Detailed description

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.

Interventions

DRUGG-CSF

Comparison of the effect of G-CSF use

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 64 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Recovery time from neutropenia30 days

Secondary

MeasureTime frame
Incidence of neutropenic fever and infectious complication30 days
Complete remission rate45 days
Overall survival3 year
Disease free survival3 year

Countries

South Korea

Contacts

Primary ContactJae-Ho Yoon, Bachelor
royoon@catholic.ac.kr+82-2-10-5227-4875
Backup ContactDahee Yoon
daheeyn811@gmail.com+82-2-10-9421-1189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026