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

April 22, 2015 updated by: Jae-Ho, Yoon, Seoul St. Mary's Hospital

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Banpodaero 222
      • Seoul, Banpodaero 222, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Comparison of the effect of G-CSF use
Other Names:
  • Filgrastim
Active Comparator: 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

Comparison of the effect of G-CSF use
Other Names:
  • Filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery time from neutropenia
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 year
3 year
Disease free survival
Time Frame: 3 year
3 year
Incidence of neutropenic fever and infectious complication
Time Frame: 30 days
30 days
Complete remission rate
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jae-Ho Yoon, Catholic BMT Center, Seoul St Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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