Trial Outcomes & Findings for G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients (NCT NCT00499343)
NCT ID: NCT00499343
Last Updated: 2013-08-02
Results Overview
After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.
Results posted on
2013-08-02
Participant Flow
Recruitment period: 02/12/2004 through 07/13/2007. All participants recruited at U.T. M.D. Anderson Cancer Center and participating institutions.
Participant milestones
| Measure |
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
|
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
Growth Factor = granulocyte-colony stimulating factor (G-CSF)
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
Baseline characteristics by cohort
| Measure |
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
n=41 Participants
Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
|
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
n=43 Participants
Growth Factor = granulocyte-colony stimulating factor (G-CSF)
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 20 and 39 years
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7.0 participants
n=5 Participants
|
|
Age, Customized
Between 40 and 59 years
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55.0 participants
n=5 Participants
|
|
Age, Customized
Between 60 and 79 years
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22.0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53.0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.
Outcome measures
| Measure |
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
n=41 Participants
Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
|
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
n=43 Participants
Growth Factor = granulocyte-colony stimulating factor (G-CSF)
|
|---|---|---|
|
CD34+ Cells/kg in Blood Stem Cells
|
7.5 CD34+ cells/kg
Interval 0.7 to 73.0
|
10.34 CD34+ cells/kg
Interval 0.14 to 59.0
|
Adverse Events
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
n=41 participants at risk
Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
|
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
n=43 participants at risk
Growth Factor = granulocyte-colony stimulating factor (G-CSF)
|
|---|---|---|
|
Blood and lymphatic system disorders
CYTOKINE RELEASE SYNDROME
|
4.9%
2/41 • 4 years and 3 months
|
0.00%
0/43 • 4 years and 3 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
17.1%
7/41 • 4 years and 3 months
|
14.0%
6/43 • 4 years and 3 months
|
|
Gastrointestinal disorders
NAUSEA/VOMITING
|
0.00%
0/41 • 4 years and 3 months
|
4.7%
2/43 • 4 years and 3 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.4%
1/41 • 4 years and 3 months
|
4.7%
2/43 • 4 years and 3 months
|
Additional Information
Chitra M. Hosing, MD / Associate Professor
U.T. M.D. Anderson Cancer Center
Phone: 713-792-8750
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place