Trial Outcomes & Findings for Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer (NCT NCT01987596)
NCT ID: NCT01987596
Last Updated: 2020-10-29
Results Overview
Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 year
Results posted on
2020-10-29
Participant Flow
Participant milestones
| Measure |
Arm I (Fixed Flexible Filgrastim Schedule)
Period 1 Fixed: Patients receive filgrastim SC QD once daily started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Flexible: Patients receive filgrastim:SC once starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
|
Arm II (Flexible Fixed Filgrastim Schedule)
Period 1 Flexible: Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Fixed: Patients receive filgrastim: given SC once daily starting on day 1 after chemotherapy in and daily thereafter until ANC reaches at least 1,000/uL post nadir.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Fixed Flexible Filgrastim Schedule)
Period 1 Fixed: Patients receive filgrastim SC QD once daily started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Flexible: Patients receive filgrastim:SC once starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
|
Arm II (Flexible Fixed Filgrastim Schedule)
Period 1 Flexible: Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Fixed: Patients receive filgrastim: given SC once daily starting on day 1 after chemotherapy in and daily thereafter until ANC reaches at least 1,000/uL post nadir.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive Disease; missing all period
|
0
|
1
|
Baseline Characteristics
Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Fixed Flexible Filgrastim Schedule)
n=11 Participants
Period 1 Fixed: Patients receive filgrastim SC QD once daily started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Flexible: Patients receive filgrastim:SC once starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
|
Arm II (Flexible Fixed Filgrastim Schedule)
n=10 Participants
Period 1 Flexible: Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
Period 2 Fixed: Patients receive filgrastim: given SC once daily starting on day 1 after chemotherapy in and daily thereafter until ANC reaches at least 1,000/uL post nadir.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=5 Participants
|
11 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 yearTime in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
Outcome measures
| Measure |
Fixed
n=21 Participants
Mean of time to ANC1000 during period participants were on fixed regimen
|
Flexible
n=21 Participants
Mean of time to ANC1000 during period participants were on flexible regimen
|
|---|---|---|
|
Days to ANC Greater Than or Equal to 1,000/uL From the Start of Chemotherapy
|
16.0 days
Interval 15.0 to 17.1
|
16.7 days
Interval 15.7 to 17.7
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Each patient server as his/her own control
occurrence of febrile neutropenia
Outcome measures
| Measure |
Fixed
n=21 Participants
Mean of time to ANC1000 during period participants were on fixed regimen
|
Flexible
n=21 Participants
Mean of time to ANC1000 during period participants were on flexible regimen
|
|---|---|---|
|
Incidence of Febrile Neutropenia
Yes
|
5 Participants
|
6 Participants
|
|
Incidence of Febrile Neutropenia
No
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up until engraftmentPopulation: Patients who had data for period 2
Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy
Outcome measures
| Measure |
Fixed
n=19 Participants
Mean of time to ANC1000 during period participants were on fixed regimen
|
Flexible
n=19 Participants
Mean of time to ANC1000 during period participants were on flexible regimen
|
|---|---|---|
|
Cumulative GCSF Dose
|
10.5 Doses
Interval 9.6 to 11.2
|
6.7 Doses
Interval 5.5 to 7.9
|
SECONDARY outcome
Timeframe: time to ANC 1000Population: All participants with period 2 data
Time (in days) to first G-CSF dose
Outcome measures
| Measure |
Fixed
n=19 Participants
Mean of time to ANC1000 during period participants were on fixed regimen
|
Flexible
n=19 Participants
Mean of time to ANC1000 during period participants were on flexible regimen
|
|---|---|---|
|
Days to First G-CSF Dose
|
5.1 days
Interval 4.5 to 5.7
|
9.5 days
Interval 8.4 to 10.5
|
Adverse Events
Arm I (Fixed Filgrastim)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Flexible Filgrastim)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Fixed Filgrastim)
n=21 participants at risk
Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
|
Arm II (Flexible Filgrastim)
n=21 participants at risk
Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
|
|---|---|---|
|
Nervous system disorders
Pain
|
19.0%
4/21 • Number of events 6 • 6 months
Nothing to mention
|
4.8%
1/21 • Number of events 2 • 6 months
Nothing to mention
|
Additional Information
Dr. Maxim Yankelevich
Barbara Ann Karmanos Cancer Institute
Phone: 313-745-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place