Trial Outcomes & Findings for Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL (NCT NCT00588094)
NCT ID: NCT00588094
Last Updated: 2015-12-04
Results Overview
assessing the response rate (CR+PR)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2015-12-04
Participant Flow
Participant milestones
| Measure |
R-ICEesc
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
R-ICEesc
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Progression of Disease
|
2
|
Baseline Characteristics
Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL
Baseline characteristics by cohort
| Measure |
R-ICEesc
n=20 Participants
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsassessing the response rate (CR+PR)
Outcome measures
| Measure |
R-ICEesc
n=17 Participants
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Improve the Overall Response Rate
Complete Remission
|
4 participants
|
|
Improve the Overall Response Rate
Complete Remission/Unconfirmed
|
2 participants
|
|
Improve the Overall Response Rate
Partial Remission
|
7 participants
|
|
Improve the Overall Response Rate
Progression of Disease
|
4 participants
|
Adverse Events
R-ICEesc
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-ICEesc
n=20 participants at risk
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Cardiac disorders
Cardiac disorder
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Delusions
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
30.0%
6/20 • Number of events 8
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Infection NOS
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Infection with grade 3/4 neut
|
10.0%
2/20 • Number of events 2
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
R-ICEesc
n=20 participants at risk
R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is \> 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
|
|---|---|
|
Investigations
Blood bilirubin increased
|
15.0%
3/20 • Number of events 8
|
|
Investigations
CPK increased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 12
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
12/20 • Number of events 259
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
55.0%
11/20 • Number of events 51
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
45.0%
9/20 • Number of events 67
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.0%
7/20 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.0%
9/20 • Number of events 60
|
|
Investigations
White blood cell decreased
|
60.0%
12/20 • Number of events 136
|
|
Investigations
Lymphocyte count decreased
|
60.0%
12/20 • Number of events 229
|
|
Investigations
Neutrophil count decreased
|
55.0%
11/20 • Number of events 48
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
4/20 • Number of events 6
|
|
Investigations
Platelet count decreased
|
55.0%
11/20 • Number of events 182
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • Number of events 7
|
Additional Information
Dr. Craig Moskowitz
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7992
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place