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

NCT ID: NCT02427919

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early G-CSF use

Refractory AML undergoing salvage chemotherapy (MEC regimen in AML). After finishing application of chemotherapy, G-CSF will be started post chemotherapy D+7~D+10 when blasts disappear from peripheral blood smear.

When blasts reappear on peripheral blood smear, G-CSF will be discontinued.

Intervention type : Drug Intervention name : G-CSF (Filgrastim)

-> Comparison of the effect of G-CSF (Filgrastim) use

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: DRUG

Comparison of the effect of G-CSF use

No or delayed G-CSF use

Refractory AML undergoing salvage chemotherapy (MEC regimen in AML). After finishing application of chemotherapy, G-CSF will not be applied at least post chemotherapy D+25~D+28. If patient suffers from severe infectious complication and when no blasts are detected on peripheral blood smear, G-CSF can be started then.

Intervention type : Drug Intervention name : G-CSF (Filgrastim)

-> Comparison of the effect of G-CSF (Filgrastim) use

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: DRUG

Comparison of the effect of G-CSF use

Interventions

G-CSF

Comparison of the effect of G-CSF use

Intervention Type: DRUG

Other Intervention Names

Filgrastim

Eligibility 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)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jae-Ho, Yoon

Clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae-Ho Yoon

Role: STUDY_CHAIR

Catholic BMT Center, Seoul St Mary's Hospital

Locations

Seoul St. Mary's Hospital

Seoul, Banpodaero 222, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jae-Ho Yoon, Bachelor

Role: CONTACT

royoon@catholic.ac.kr

+82-2-10-5227-4875

Dahee Yoon

Role: CONTACT

daheeyn811@gmail.com

+82-2-10-9421-1189

Facility Contacts

Jae-Ho Yoon

Role: primary

royoon@catholic.ac.kr

+82-2-01-5227-4875

Other Identifiers

CHSCTC-R02-DeGREE

Identifier Type: -

Identifier Source: org_study_id