Trial Outcomes & Findings for Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis (NCT NCT02385110)
NCT ID: NCT02385110
Last Updated: 2024-01-17
Results Overview
Response is defined as complete response (CR) and/or partial response (PR) and/or parameter improvements (PI). Complete response (CR) is normalization to within institutional normal limits of diagnostic clinical and laboratory abnormalities associated with HLH. In the case of ferritin, normalization OR a 3 fold improvement in the pre-study level will be evidence of complete response, provided the post therapy level is also below 10000 ng/ml. Partial response (PR) is sustained normalization of 3 or more of the diagnostic clinical and laboratory abnormalities noted above (or, with ferritin, improvement as described above) and no apparent progression of other aspects of disease pathology. Parameter improvements (PI) is at least a 25% improvement in two or more quantifiable symptoms and/or laboratory markers from those mentioned above within 8 weeks (+/- 7 days) of initiation of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-01-17
Participant Flow
Participant milestones
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
16
|
|
Overall Study
COMPLETED
|
1
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
Overall Study
Early Death
|
1
|
0
|
Baseline Characteristics
Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
Baseline characteristics by cohort
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
n=2 Participants
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
n=16 Participants
IInduction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
n=5 Participants
|
54 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Of the two participants in Group 1, only one participant was evaluable for response. Of the sixteen participants in Group 2, only eight were evaluable for response.
Response is defined as complete response (CR) and/or partial response (PR) and/or parameter improvements (PI). Complete response (CR) is normalization to within institutional normal limits of diagnostic clinical and laboratory abnormalities associated with HLH. In the case of ferritin, normalization OR a 3 fold improvement in the pre-study level will be evidence of complete response, provided the post therapy level is also below 10000 ng/ml. Partial response (PR) is sustained normalization of 3 or more of the diagnostic clinical and laboratory abnormalities noted above (or, with ferritin, improvement as described above) and no apparent progression of other aspects of disease pathology. Parameter improvements (PI) is at least a 25% improvement in two or more quantifiable symptoms and/or laboratory markers from those mentioned above within 8 weeks (+/- 7 days) of initiation of therapy.
Outcome measures
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
n=1 Participants
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
n=8 Participants
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
|
1 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Of the two participants in Group 1, only one participant was evaluable for response. Of the 16 participants in Group 2, only eight were evaluable for response.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
n=1 Participants
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
n=8 Participants
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
Disease Free Survival
|
1.9 Months
|
1.9 Months
Interval 0.8 to 5.0
|
Adverse Events
Group 1: Alemtuzumab + Etoposide + Dexamethasone
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Group 2: Etoposide + Dexamethasone + Tocilizumab
Serious events: 9 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
n=2 participants at risk
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
n=16 participants at risk
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Rectal Bleeding
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
Infections and infestations
Bacteremia
|
0.00%
0/2 • Up to 7 years, 3 months
|
18.8%
3/16 • Number of events 3 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
General disorders
Abdominal Pain
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
Other adverse events
| Measure |
Group 1: Alemtuzumab + Etoposide + Dexamethasone
n=2 participants at risk
Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Dexamethasone by vein on Days 1-7 of the induction phase.
Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
|
Group 2: Etoposide + Dexamethasone + Tocilizumab
n=16 participants at risk
Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.
Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.
If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
25.0%
4/16 • Number of events 4 • Up to 7 years, 3 months
|
|
Vascular disorders
Catheter Related Deep Vein Thrombosis
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
0.00%
0/16 • Up to 7 years, 3 months
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
37.5%
6/16 • Number of events 6 • Up to 7 years, 3 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
25.0%
4/16 • Number of events 4 • Up to 7 years, 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
31.2%
5/16 • Number of events 5 • Up to 7 years, 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
1/2 • Number of events 1 • Up to 7 years, 3 months
|
25.0%
4/16 • Number of events 4 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
Investigations
Transamintis
|
0.00%
0/2 • Up to 7 years, 3 months
|
50.0%
8/16 • Number of events 8 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Vascular disorders
Right thumb ischemia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2 • Up to 7 years, 3 months
|
56.2%
9/16 • Number of events 9 • Up to 7 years, 3 months
|
|
Infections and infestations
Epstein-Barr Virus
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/2 • Up to 7 years, 3 months
|
18.8%
3/16 • Number of events 3 • Up to 7 years, 3 months
|
|
Investigations
Creatinine Increase
|
0.00%
0/2 • Up to 7 years, 3 months
|
31.2%
5/16 • Number of events 5 • Up to 7 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Blood and lymphatic system disorders
Increased Phosphorous
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
General disorders
Swelling
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/2 • Up to 7 years, 3 months
|
18.8%
3/16 • Number of events 3 • Up to 7 years, 3 months
|
|
General disorders
Chills
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
General disorders
edema
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Skin and subcutaneous tissue disorders
erythmea
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Up to 7 years, 3 months
|
12.5%
2/16 • Number of events 2 • Up to 7 years, 3 months
|
|
General disorders
Pain
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Up to 7 years, 3 months
|
6.2%
1/16 • Number of events 1 • Up to 7 years, 3 months
|
Additional Information
Naval Daver, MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place