Trial Outcomes & Findings for Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells (NCT NCT01097057)
NCT ID: NCT01097057
Last Updated: 2018-01-23
Results Overview
Number of patients who achieved ≥5 x 10\^6 CD34 cells/kg autologous PBSC collection by apheresis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
One Month
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Baseline characteristics by cohort
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=20 Participants
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=39 Participants
|
|
Age, Continuous
|
66 Years
n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: One MonthNumber of patients who achieved ≥5 x 10\^6 CD34 cells/kg autologous PBSC collection by apheresis.
Outcome measures
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=17 Participants
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to Four Apheresis DaysNumber of patients to collect at least 5 x 10\^6 CD34 cells/kg in under 4 apheresis procedures.
Outcome measures
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=17 Participants
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to Four Apheresis DaysNumber of participants requiring one or two apheresis collection days to reach collection goal.
Outcome measures
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=17 Participants
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
One apheresis collection day
|
15 Participants
|
|
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Two apheresis collection days
|
2 Participants
|
|
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Three apheresis collection days
|
0 Participants
|
|
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Four apheresis collection days
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Four Apheresis DaysPopulation: Note: No patients were in this category.
Number of participants who did not collect ≥5 x 10\^6 CD34 cells/kg in up to four apheresis days
Outcome measures
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=17 Participants
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
|
0 Participants
|
Adverse Events
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=20 participants at risk
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.0%
1/20
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20
|
Other adverse events
| Measure |
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
n=20 participants at risk
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV
|
|---|---|
|
Vascular disorders
DVT
|
5.0%
1/20
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20
|
Additional Information
Dr. Leona A. Holmberg
Fred Hutchinson Cancer Research Center
Phone: 206-667-6447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place