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

NCT02427919 | Unknown Phase 2 DMC

• 1 other identifier: CHSCTC-R02-DeGREE
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recovery time from neutropenia

  30 days

Secondary Outcomes (4)

• Incidence of neutropenic fever and infectious complication

  30 days

• Complete remission rate

  45 days

• Overall survival

  3 year

• Disease free survival

  3 year

Study Arms (2)

Early G-CSF use

EXPERIMENTAL

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

Drug: G-CSF

No or delayed G-CSF use

ACTIVE COMPARATOR

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

Drug: G-CSF

Interventions

G-CSF DRUG

Comparison of the effect of G-CSF use

Also known as: Filgrastim

Early G-CSF use; No or delayed G-CSF use

Eligibility Criteria

• Age: 17 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Banpodaero 222, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Febrile Neutropenia

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jae-Ho Yoon

  Catholic BMT Center, Seoul St Mary's Hospital

  STUDY CHAIR

Central Study Contacts

Jae-Ho Yoon, Bachelor

CONTACT

+82-2-10-5227-4875; royoon@catholic.ac.kr

Dahee Yoon

CONTACT

+82-2-10-9421-1189; daheeyn811@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 28, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

KR (1)