Trial Outcomes & Findings for Phase 2 Study of Bexxar in Relapsed/Refractory DLCL (NCT NCT00490009)
NCT ID: NCT00490009
Last Updated: 2017-03-30
Results Overview
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
6 years
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Bexxar
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Baseline characteristics by cohort
| Measure |
Bexxar
n=9 Participants
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 yearsClinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
Outcome measures
| Measure |
Bexxar
n=9 Participants
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
|
|---|---|
|
Clinical Response Rate
Clinical Response
|
2 participants
|
|
Clinical Response Rate
Complete Response (CR)
|
0 participants
|
|
Clinical Response Rate
Functional CR
|
1 participants
|
|
Clinical Response Rate
PR
|
1 participants
|
|
Clinical Response Rate
SD
|
6 participants
|
|
Clinical Response Rate
PD
|
1 participants
|
SECONDARY outcome
Timeframe: 1.5 months; 3 months; 6 months; or Not ProgressedPopulation: 1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.
Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
Outcome measures
| Measure |
Bexxar
n=8 Participants
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
|
|---|---|
|
Time to Progression (TTP)
1.5 months
|
1 participants
|
|
Time to Progression (TTP)
3 months
|
2 participants
|
|
Time to Progression (TTP)
6 months
|
2 participants
|
|
Time to Progression (TTP)
Not Progressed
|
3 participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: 1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.
Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Outcome measures
| Measure |
Bexxar
n=8 Participants
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
|
|---|---|
|
Overall Survival (OS) Rate
|
37.5 percentage of participants
|
Adverse Events
Bexxar + Tylenol + Benadryl + SSKI
Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bexxar + Tylenol + Benadryl + SSKI
n=9 participants at risk
Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
55.6%
5/9 • Number of events 5 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Stricture
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Vomitting
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Thromnocytopenia
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Stenosis (including anastomotic GI- Blilary tree)
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Anemia-tachycardia
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
hypotension
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Leukocytoperia
|
22.2%
2/9 • Number of events 2 • 3 months
|
Other adverse events
| Measure |
Bexxar + Tylenol + Benadryl + SSKI
n=9 participants at risk
Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
9/9 • Number of events 9 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pains
|
55.6%
5/9 • Number of events 5 • 3 months
|
|
Eye disorders
Blurred visiom
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Burning Throat after SSKI
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Diarrehea
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
General disorders
Fatigue
|
100.0%
9/9 • Number of events 9 • 3 months
|
|
General disorders
Fatigue secondary to dexamethasone
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Nervous system disorders
Foot Numbness
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
High Neutrophil count
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
General disorders
Left side is sore
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
General disorders
Leg Swelling during the day
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Nervous system disorders
Lethargy
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Blood and lymphatic system disorders
Leukocytoperia
|
100.0%
9/9 • Number of events 9 • 3 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Loose Stools
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Ear and labyrinth disorders
Loss of balance
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Metabolism and nutrition disorders
Low Potassium
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Nervous system disorders
Memory Loss
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Nervous system disorders
Mild headaches
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Skin and subcutaneous tissue disorders
Neck Irritated
|
22.2%
2/9 • Number of events 2 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Neutroperia
|
77.8%
7/9 • Number of events 7 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Numbness
|
44.4%
4/9 • Number of events 4 • 3 months
|
|
General disorders
Pain
|
33.3%
3/9 • Number of events 3 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Investigations
Renal insufficiency
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
General disorders
Swelling
|
44.4%
4/9 • Number of events 4 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Throbbing Intermittent
|
44.4%
4/9 • Number of events 4 • 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
9/9 • Number of events 9 • 3 months
|
|
Gastrointestinal disorders
Upset Stomach
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin Cancers
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Small cold
|
11.1%
1/9 • Number of events 1 • 3 months
|
Additional Information
Susan J Knox, MD, Associate Professor of Radiation Oncology
Stanford University Medical Center
Phone: 650-725-2720
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place