Trial Outcomes & Findings for Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy (NCT NCT00490490)
NCT ID: NCT00490490
Last Updated: 2017-03-29
Results Overview
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
TERMINATED
PHASE2
8 participants
12 weeks
2017-03-29
Participant Flow
Participant milestones
| Measure |
Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Completed Assessment for CR
STARTED
|
8
|
|
Completed Assessment for CR
COMPLETED
|
8
|
|
Completed Assessment for CR
NOT COMPLETED
|
0
|
|
Completed Assessment for TTP
STARTED
|
8
|
|
Completed Assessment for TTP
COMPLETED
|
5
|
|
Completed Assessment for TTP
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Completed Assessment for TTP
Withdrawal by Subject
|
1
|
|
Completed Assessment for TTP
Lost to Follow-up
|
2
|
Baseline Characteristics
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Baseline characteristics by cohort
| Measure |
Tositumomab + XRT + KI
n=8 Participants
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
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
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Histology
Follicular Lymphoma, Grade 1
|
2 Participants
n=5 Participants
|
|
Histology
Follicular Lymphoma, Grade 2
|
2 Participants
n=5 Participants
|
|
Histology
Follicular Lymphoma, Grade 3
|
2 Participants
n=5 Participants
|
|
Histology
Marginal Zone B-Cell Lymphoma
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksParticipants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
Outcome measures
| Measure |
Tositumomab + XRT + KI
n=8 Participants
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Complete Response (CR) Rate
CR
|
37.5 percentage of participants
|
|
Complete Response (CR) Rate
Partial response (PR) or stable disease (SD)
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksORR is assessed as the sum of the overall rates of * CR confirmed by positron emission tomography (PET) * CR not confirmed by PET, and * Partial response (PR) negative for progression by PET
Outcome measures
| Measure |
Tositumomab + XRT + KI
n=8 Participants
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Overall Response Rate (ORR)
All CR + PR
|
50 percentage of participants
|
|
Overall Response Rate (ORR)
Partial Response (PR)
|
12.5 percentage of participants
|
|
Overall Response Rate (ORR)
Stable Disease (SD)
|
50 percentage of participants
|
|
Overall Response Rate (ORR)
Progressive disease (PD)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: One subject has not progressed (assessment not possible), and one subject has been lost to follow-up.
Outcome measures
| Measure |
Tositumomab + XRT + KI
n=6 Participants
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Time-to-Progression (TTP)
3 months
|
1 Participants
|
|
Time-to-Progression (TTP)
6 months
|
1 Participants
|
|
Time-to-Progression (TTP)
9 months
|
1 Participants
|
|
Time-to-Progression (TTP)
18 months
|
2 Participants
|
|
Time-to-Progression (TTP)
60 months
|
1 Participants
|
Adverse Events
Tositumomab + XRT + KI
Serious adverse events
| Measure |
Tositumomab + XRT + KI
n=8 participants at risk
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • Number of events 7 • 12 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
8/8 • Number of events 8 • 12 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
4/8 • Number of events 10 • 12 weeks
|
Other adverse events
| Measure |
Tositumomab + XRT + KI
n=8 participants at risk
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
8/8 • Number of events 8 • 12 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
87.5%
7/8 • Number of events 7 • 12 weeks
|
|
Blood and lymphatic system disorders
Thrombocytoperia
|
100.0%
8/8 • Number of events 8 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
37.5%
3/8 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 5 • 12 weeks
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
100.0%
8/8 • Number of events 8 • 12 weeks
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Headaches
|
62.5%
5/8 • Number of events 15 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 2 • 12 weeks
|
|
Ear and labyrinth disorders
Equilibrium abnormal
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
General disorders
Body aches
|
25.0%
2/8 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Infection, Finger
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Itchiness, hands and feet
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Mouth Sores
|
12.5%
1/8 • Number of events 3 • 12 weeks
|
|
Nervous system disorders
Neuropathy
|
25.0%
2/8 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
25.0%
2/8 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
25.0%
2/8 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Swollem Lymph Nodes
|
12.5%
1/8 • Number of events 2 • 12 weeks
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Chest Pain
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Lung Infection
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Indigestion
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back spasms
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Hip/Leg
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain at biopsy site (lower back)
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
R Armpit Pain
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain, side
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Headache, Chronic
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Itchiness, nose and mouth
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
Additional Information
Susan J. Knox, MD, Associate Professor of Radiation Oncology
Stanford University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place