Trial Outcomes & Findings for Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT NCT01527149)
NCT ID: NCT01527149
Last Updated: 2024-02-07
Results Overview
Evaluated according to the International Working Group Response criteria as reported by Cheson et al. and the revised Cheson criteria. Complete response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Typically FDG-avid lymphoma: in patients with PET scan positive before therapy, a posttreatment residual mass of any size is permitted as long as it is PET negative. Variably FDG-avid lymphomas/FDG avidity unknown: in patients with a negative pretreatment PET scan, all lymph nodes and nodal masses must have regressed on CT to normal size (1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). Previously involved nodes that were 1.1 cm to 1.5 cm in their long axis and more than 1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
22 weeks
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 weeksPopulation: All treated and eligible patients
Evaluated according to the International Working Group Response criteria as reported by Cheson et al. and the revised Cheson criteria. Complete response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Typically FDG-avid lymphoma: in patients with PET scan positive before therapy, a posttreatment residual mass of any size is permitted as long as it is PET negative. Variably FDG-avid lymphomas/FDG avidity unknown: in patients with a negative pretreatment PET scan, all lymph nodes and nodal masses must have regressed on CT to normal size (1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). Previously involved nodes that were 1.1 cm to 1.5 cm in their long axis and more than 1)
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Proportion of Patients Experiencing a Complete Response
|
.62 Proportion of participants
Interval 0.45 to 0.78
|
SECONDARY outcome
Timeframe: Up to 6 weeks after the last dose of ofatumumab-chemotherapy, an average of 4 monthPopulation: All treated and eligible patients
Estimated using simple relative frequencies. The corresponding 95% confidence intervals will be computed using the method proposed in Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Percentage of Participants With Autologous Stem Cell Transplantation
|
73 percentage of participants
Interval 55.0 to 86.0
|
SECONDARY outcome
Timeframe: Baseline and up to 3 yearsPopulation: All treated and eligible patients that had samples taken after baseline
Mean change from baseline in Percentage of Cells Positive for Ki67 by patient response.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=2 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Change From Baseline in Percentage of Cells Positive for Ki67
Not CR
|
-2.5 percentage of cells positive for Ki-67
Standard Deviation 10.6
|
|
Change From Baseline in Percentage of Cells Positive for Ki67
CR
|
NA percentage of cells positive for Ki-67
Standard Deviation NA
No patients with Ki67 measures after baseline had CR
|
SECONDARY outcome
Timeframe: BaselinePopulation: All treated and evaluable patients
Median serum C20 MFI (mean fluorescence intensity)
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=19 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Median of Serum Complement CD20 Levels
|
186.8 mean fluorescence intensity
Interval 0.0 to 480.2
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated and eligible patients
Evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Number of Participants With at Least One Serious Adverse Event
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated and eligible patients with available samples
Minimal residual disease (MRD) in peripheral blood samples at baseline.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=31 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Minimal Residual Disease (MRD) in Peripheral Blood Samples
Negative
|
2 Participants
|
|
Minimal Residual Disease (MRD) in Peripheral Blood Samples
Postive
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated and eligible patients with available samples
Minimal residual disease (MRD) in and bone marrow biopsy/aspiration samples at baseline.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=30 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Minimal Residual Disease (MRD) in Bone Marrow Biopsy/Aspiration Samples
Negative
|
6 Participants
|
|
Minimal Residual Disease (MRD) in Bone Marrow Biopsy/Aspiration Samples
Postive
|
24 Participants
|
SECONDARY outcome
Timeframe: From baseline through study completion, an average of 5 yearsPopulation: All treated and eligible patients
Estimated distributions obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Median Overall Survival (OS)
|
56.0 months
Interval 39.8 to 78.0
|
SECONDARY outcome
Timeframe: From baseline through study completion, an average of 5 yearsPopulation: All treated and eligible patients
Estimated distributions obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Median Progression-free Survival (PFS)
|
45.5 months
Interval 21.4 to 78.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Samples were not viable due to inadequate tissue.
Relationship between proliferation signature and clinical outcome will be compared using the log-rank test. Cox proportional hazards model regression will be utilized for multivariate analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated and eligible patients
Established when all CR criteria are met and negative flow cytometry examination of peripheral blood and bone marrow biopsy/aspiration collected at baseline, before courses 3 and 5, within 3 weeks after course 6, on day 100 (if HDC-ASCT eligible), and then every 6 months for 3 years.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Proportion of Patients Who Experience Complete Remission as Assessed by HSFCM
|
.84 Proportion of participants
Interval 0.68 to 0.94
|
SECONDARY outcome
Timeframe: From baseline until objective tumor progression, as assessed up to 3 yearsPopulation: All treated and eligible patients
Estimated percentage of patients that progressed at 3 years. Time to Progression distributions obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 Participants
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Time-to-tumor Progression (TTP) at 3 Years
|
76 percentage of participants
Interval 57.0 to 87.0
|
Adverse Events
Treatment (Monoclonal Antibody and Combination Chemotherapy)
Serious events: 19 serious events
Other events: 37 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 participants at risk
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Periorbital oedema
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Diverticulitis
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Infusion site infection
|
8.1%
3/37 • Number of events 17 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Lung infection
|
5.4%
2/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Neutropenic sepsis
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Parainfluenzae virus infection
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Sepsis
|
21.6%
8/37 • Number of events 56 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Neutrophil count decreased
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Cytarabine syndrome
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
2.7%
1/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Arachnoiditis
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
Other adverse events
| Measure |
Treatment (Monoclonal Antibody and Combination Chemotherapy)
n=37 participants at risk
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.
COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligible patients then undergo standard HDC-ASCT.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Methotrexate: Given IV
Ofatumumab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
83.8%
31/37 • Number of events 291 • From the start date of intervention through study completion, an average of 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.5%
15/37 • Number of events 51 • From the start date of intervention through study completion, an average of 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
2/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.8%
4/37 • Number of events 37 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Pericarditis
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Cardiac disorders
Tachycardia
|
8.1%
3/37 • Number of events 8 • From the start date of intervention through study completion, an average of 5 years
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Dry eye
|
10.8%
4/37 • Number of events 10 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Eye disorder
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Eye haemorrhage
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Eye pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Lacrimation increased
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Periorbital oedema
|
10.8%
4/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Photophobia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Eye disorders
Vision blurred
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
5/37 • Number of events 19 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Constipation
|
48.6%
18/37 • Number of events 46 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
10/37 • Number of events 42 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
21.6%
8/37 • Number of events 23 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Flatulence
|
10.8%
4/37 • Number of events 10 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
18.9%
7/37 • Number of events 15 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Lip dry
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Nausea
|
75.7%
28/37 • Number of events 128 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Oral disorder
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Proctalgia
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
24.3%
9/37 • Number of events 44 • From the start date of intervention through study completion, an average of 5 years
|
|
Gastrointestinal disorders
Vomiting
|
45.9%
17/37 • Number of events 73 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Adverse drug reaction
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Asthenia
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Catheter site oedema
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Catheter site pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Chest pain
|
10.8%
4/37 • Number of events 11 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Chills
|
8.1%
3/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Face oedema
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Fatigue
|
40.5%
15/37 • Number of events 48 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Influenza like illness
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Infusion site erythema
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Infusion site haemorrhage
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Infusion site pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Infusion site rash
|
5.4%
2/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Infusion site reaction
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Injection site reaction
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Localised oedema
|
10.8%
4/37 • Number of events 13 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Malaise
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Mucosal inflammation
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Oedema
|
5.4%
2/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Oedema peripheral
|
40.5%
15/37 • Number of events 38 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Pain
|
21.6%
8/37 • Number of events 18 • From the start date of intervention through study completion, an average of 5 years
|
|
General disorders
Pyrexia
|
45.9%
17/37 • Number of events 106 • From the start date of intervention through study completion, an average of 5 years
|
|
Immune system disorders
Cytokine release syndrome
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Immune system disorders
Hypersensitivity
|
5.4%
2/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Anorectal infection
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Cellulitis
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Diverticulitis
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Lung infection
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Pharyngitis
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Pseudomonas infection
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Septic embolus
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Skin infection
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Tuberculosis
|
2.7%
1/37 • Number of events 1 • From the start date of intervention through study completion, an average of 5 years
|
|
Infections and infestations
Urinary tract infection
|
8.1%
3/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
78.4%
29/37 • Number of events 87 • From the start date of intervention through study completion, an average of 5 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Alanine aminotransferase increased
|
18.9%
7/37 • Number of events 17 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.2%
6/37 • Number of events 16 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Blood bilirubin increased
|
8.1%
3/37 • Number of events 22 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Blood creatinine increased
|
10.8%
4/37 • Number of events 44 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Blood magnesium decreased
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Lymphocyte count decreased
|
5.4%
2/37 • Number of events 29 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Neutrophil count decreased
|
43.2%
16/37 • Number of events 196 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Platelet count decreased
|
86.5%
32/37 • Number of events 345 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
Weight decreased
|
10.8%
4/37 • Number of events 13 • From the start date of intervention through study completion, an average of 5 years
|
|
Investigations
White blood cell count decreased
|
24.3%
9/37 • Number of events 104 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.3%
9/37 • Number of events 23 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
32.4%
12/37 • Number of events 54 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
10.8%
4/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
43.2%
16/37 • Number of events 41 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.1%
3/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.4%
2/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
5.4%
2/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.8%
4/37 • Number of events 18 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.1%
3/37 • Number of events 8 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
45.9%
17/37 • Number of events 143 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.9%
7/37 • Number of events 21 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.8%
4/37 • Number of events 11 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
4/37 • Number of events 29 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.1%
3/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Cytarabine syndrome
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.1%
3/37 • Number of events 8 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
2/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
4/37 • Number of events 13 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.5%
5/37 • Number of events 15 • From the start date of intervention through study completion, an average of 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
3/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Dizziness
|
13.5%
5/37 • Number of events 16 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Dysgeusia
|
29.7%
11/37 • Number of events 30 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Dysmetria
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Headache
|
45.9%
17/37 • Number of events 68 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Lethargy
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Paraesthesia
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.2%
6/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Taste disorder
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Product Issues
Thrombosis in device
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Psychiatric disorders
Anxiety
|
27.0%
10/37 • Number of events 26 • From the start date of intervention through study completion, an average of 5 years
|
|
Psychiatric disorders
Confusional state
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Psychiatric disorders
Depression
|
10.8%
4/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Psychiatric disorders
Insomnia
|
18.9%
7/37 • Number of events 18 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
1/37 • Number of events 13 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Dysuria
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Haematuria
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Pollakiuria
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Urinary retention
|
8.1%
3/37 • Number of events 9 • From the start date of intervention through study completion, an average of 5 years
|
|
Renal and urinary disorders
Urinary tract pain
|
5.4%
2/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 11 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.6%
8/37 • Number of events 20 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.6%
8/37 • Number of events 38 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.8%
4/37 • Number of events 11 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.5%
5/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.7%
1/37 • Number of events 5 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
2/37 • Number of events 8 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
1/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.1%
3/37 • Number of events 8 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.1%
3/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.4%
2/37 • Number of events 4 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.8%
4/37 • Number of events 10 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.7%
1/37 • Number of events 1 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.2%
6/37 • Number of events 15 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
3/37 • Number of events 14 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37 • Number of events 12 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.5%
5/37 • Number of events 20 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.4%
2/37 • Number of events 11 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Embolism
|
2.7%
1/37 • Number of events 2 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Flushing
|
2.7%
1/37 • Number of events 3 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Hypertension
|
8.1%
3/37 • Number of events 7 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Hypotension
|
13.5%
5/37 • Number of events 13 • From the start date of intervention through study completion, an average of 5 years
|
|
Vascular disorders
Jugular vein thrombosis
|
5.4%
2/37 • Number of events 6 • From the start date of intervention through study completion, an average of 5 years
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place