Leukemia, Myeloid, AcutePhase 2/3DeGREENCT02427919
Granulocyte Colony Stimulating Factor (G-CSF) After Salvage Chemotherapy in Refractory AML
A Phase 2/3 study testing G-CSF in people with Leukemia, Myeloid, Acute, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 64 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul, Banpodaero 222, 137-701
Jae-Ho Yoon, +82-2-01-5227-4875, royoon@catholic.ac.kr
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- G-CSF
- Keywords
- G-CSF, G-CSF receptor, AML, refractory AML, Neutropenic fever, salvage chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called Filgrastim
Comparison of the effect of G-CSF use
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time from neutropenia
Measured: 30 days
Secondary outcomes (4)
Incidence of neutropenic fever and infectious complication
Measured: 30 days
Complete remission rate
Measured: 45 days
Overall survival
Measured: 3 year
Disease free survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Ho, Yoon, Seoul St. Mary's Hospital
- Investigators
- Jae-Ho Yoon, Study chair, Catholic BMT Center, Seoul St Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427919
- Sponsor's protocol ID
- CHSCTC-R02-DeGREE
- Acronym
- DeGREE
- Status last verified
- Apr 2015
- First submitted
- 17 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02427919
- Acronym / sponsor ID
- DeGREE / CHSCTC-R02-DeGREE
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- G-CSF, G-CSF receptor, AML, refractory AML, Neutropenic fever, salvage chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early G-CSF use | Experimental | Drug: G-CSFRefractory 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 |
| No or delayed G-CSF use | Active comparator | Drug: G-CSFRefractory 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 |
Who may qualify
- Ages
- 17 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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%)
Key exclusion criteria (7 listed)
- Acute promyelocytic leukemia
- Central nervous system (CNS) involvement
- Uncontrolled bleeding
- Uncontrolled infectious complication
- Pregnancy, Breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: FilgrastimComparison of the effect of G-CSF use | Drug | Early G-CSF use, No or delayed G-CSF use |
Primary outcome
Recovery time from neutropenia
Time frame: 30 days
4 secondary outcomes
Incidence of neutropenic fever and infectious complication
Time frame: 30 days
Complete remission rate
Time frame: 45 days
Overall survival
Time frame: 3 year
Disease free survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Ho Yoon study chair
Catholic BMT Center, Seoul St Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing G-CSF in people with Leukemia, Myeloid, Acute, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Ho Yoon, Bachelor (+82-2-10-5227-4875, royoon@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time from neutropenia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.