Trial Outcomes & Findings for Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab (NCT NCT01119794)
NCT ID: NCT01119794
Last Updated: 2015-08-26
Results Overview
Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only. Complete Response - CR: • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response - PR: • At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable Disease - SD: • A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease Relapsed Disease: • Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis.
TERMINATED
PHASE2
10 participants
Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years
2015-08-26
Participant Flow
Participant milestones
| Measure |
Ofatumumab IV,
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab
Baseline characteristics by cohort
| Measure |
Ofatumumab IV,
n=10 Participants
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 yearsPopulation: 8/10 patients were evaluable as 2 withdrew
Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only. Complete Response - CR: • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response - PR: • At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable Disease - SD: • A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease Relapsed Disease: • Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis.
Outcome measures
| Measure |
Ofatumumab IV,
n=8 Participants
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
|
|---|---|
|
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
CR
|
2 participants
|
|
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
PR
|
1 participants
|
|
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
SD
|
3 participants
|
|
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
Progression
|
2 participants
|
Adverse Events
Ofatumumab IV,
Serious adverse events
| Measure |
Ofatumumab IV,
n=10 participants at risk
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
1/10 • Number of events 1
|
|
Investigations
nausea
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
vomitting
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Ofatumumab IV,
n=10 participants at risk
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
|
|---|---|
|
Investigations
infusion reaction
|
70.0%
7/10 • Number of events 7
|
|
Gastrointestinal disorders
diarrhea
|
40.0%
4/10 • Number of events 4
|
|
Investigations
glucose
|
60.0%
6/10 • Number of events 6
|
|
Investigations
abdominal pain
|
10.0%
1/10 • Number of events 1
|
|
Investigations
nausea
|
30.0%
3/10 • Number of events 3
|
|
Investigations
shortness of breath
|
20.0%
2/10 • Number of events 2
|
|
Investigations
edema
|
30.0%
3/10 • Number of events 3
|
|
Investigations
fatigue
|
40.0%
4/10 • Number of events 4
|
|
Investigations
white blood cell decrease
|
20.0%
2/10 • Number of events 2
|
|
General disorders
general pain
|
20.0%
2/10 • Number of events 2
|
|
Investigations
rash
|
30.0%
3/10 • Number of events 3
|
|
Investigations
derm skin other
|
20.0%
2/10 • Number of events 2
|
|
Investigations
anemia
|
60.0%
6/10 • Number of events 6
|
|
Investigations
thrombocytopenia
|
50.0%
5/10 • Number of events 5
|
|
Investigations
neuropathy
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
10.0%
1/10 • Number of events 1
|
|
Investigations
neutropenia
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Red blodd cell
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Lymphopenia
|
40.0%
4/10 • Number of events 4
|
|
Investigations
hyponatremia
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Liver function test abnormalities
|
20.0%
2/10 • Number of events 2
|
|
General disorders
muscle aches
|
10.0%
1/10 • Number of events 1
|
|
Investigations
phosphorus
|
20.0%
2/10 • Number of events 2
|
|
Investigations
sweating
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
mood alteration
|
10.0%
1/10 • Number of events 1
|
|
Investigations
phlebitis
|
10.0%
1/10 • Number of events 1
|
|
Investigations
creatinine
|
10.0%
1/10 • Number of events 1
|
|
Investigations
dehydration
|
10.0%
1/10 • Number of events 1
|
|
Investigations
hip pain
|
10.0%
1/10 • Number of events 1
|
|
Investigations
cough
|
10.0%
1/10 • Number of events 1
|
|
Investigations
back pain
|
10.0%
1/10 • Number of events 1
|
|
Investigations
heartburn
|
10.0%
1/10 • Number of events 1
|
|
Investigations
upper respiratory infection
|
10.0%
1/10 • Number of events 1
|
Additional Information
Eric Winer, MD
Brown University Oncology Research Group (BrUOG)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place