- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427919
Granulocyte Colony Stimulating Factor (G-CSF) After Salvage Chemotherapy in Refractory AML (DeGREE)
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
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Jae-Ho Yoon, Bachelor
- Phone Number: +82-2-10-5227-4875
- Email: royoon@catholic.ac.kr
Study Contact Backup
- Name: Dahee Yoon
- Phone Number: +82-2-10-9421-1189
- Email: daheeyn811@gmail.com
Study Locations
-
-
Banpodaero 222
-
Seoul, Banpodaero 222, Korea, Republic of, 137-701
- Recruiting
- Seoul St. Mary's Hospital
-
Contact:
- Jae-Ho Yoon
- Phone Number: +82-2-01-5227-4875
- Email: royoon@catholic.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Investigators
- Study Chair: Jae-Ho Yoon, Catholic BMT Center, Seoul St Mary's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHSCTC-R02-DeGREE
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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