Trial Outcomes & Findings for EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection (NCT NCT00006436)
NCT ID: NCT00006436
Last Updated: 2025-12-30
Results Overview
PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
The participants were followed for a median of 15.4 years.
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
|---|---|
|
Overall Study
Refused further treatment
|
2
|
|
Overall Study
Declined to participate (before treatment started)
|
1
|
Baseline Characteristics
EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
Baseline characteristics by cohort
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=68 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=174 Participants
|
|
Age, Continuous
|
42.36 years
STANDARD_DEVIATION 10.7 • n=174 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=174 Participants
|
|
Region of Enrollment
United States
|
68 Participants
n=174 Participants
|
PRIMARY outcome
Timeframe: The participants were followed for a median of 15.4 years.Population: One participant declined to participate before treatment started.
PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
13.8 years
Interval 10.2 to
Upper end confidence interval is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: One participant declined to participate before treatment started.
PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s).
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Progression Free Survival at 1 Year
|
79.1 percentage of participants
Interval 67.3 to 87.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.Population: One participant declined to participate before treatment started.
Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
n=67 Participants
Grade 4 is life threatening.
|
Grade 5
n=67 Participants
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Diarrhea
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Constipation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Serious hemorrhage
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Fatigue
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Headache
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Bone pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Anorexia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hypoxia
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Myelodysplastic syndrome
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hypophosphatemia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hypocalcemia
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hypokalemia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hyponatremia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Dehydration
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Mucositis/Stomatitis
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Liver test abnormalities
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Pancreatitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Hyperglycemia
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Vision disturbance
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Serious infection
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Neurologic event
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Syncope
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Motor neuropathy
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The participants were followed for survival for a median of 15.4 years.Population: One participant declined to participate before treatment started.
Overall survival is time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Median Overall Survival
|
14.2 years
Interval 13.2 to
Upper end confidence interval is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One participant declined to participate before treatment started.
Overall survival is time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
1 Year Overall Survival
|
83.7 percentage of participants
Interval 71.0 to 91.2
|
—
|
—
|
SECONDARY outcome
Timeframe: The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years.Population: One participant declined to participate before treatment started.
Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Median Duration of Complete Response/Complete Response Unconfirmed
|
13.9 years
Interval 13.1 to
Upper end confidence interval is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One participant declined to participate before treatment started.
Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With CR/CRu Lasting 1 Year
|
82.5 percentage of participants
Interval 70.7 to 89.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.Population: One participant declined to participate before treatment started.
Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 112 cycles (each cycle is 21 days + 7 days window)Population: One participant declined to participate before treatment started.
Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0).
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Number of Cycles of Hematologic Toxicity
Febrile neutropenia
|
25 cycles
|
—
|
—
|
|
Number of Cycles of Hematologic Toxicity
Neutropenia with a Nadir <500 cells/mm^3
|
112 cycles
|
—
|
—
|
|
Number of Cycles of Hematologic Toxicity
Neutropenia with a Nadir <100 cells/mm^3
|
77 cycles
|
—
|
—
|
|
Number of Cycles of Hematologic Toxicity
Thrombocytopenia with a Nadir <50,000 platelets/mm^3
|
40 cycles
|
—
|
—
|
|
Number of Cycles of Hematologic Toxicity
Thrombocytopenia with a Nadir <25,000 platelets/mm^3
|
6 cycles
|
—
|
—
|
|
Number of Cycles of Hematologic Toxicity
Anemia: hemoglobin <8 g/dL
|
36 cycles
|
—
|
—
|
SECONDARY outcome
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.Population: One participant declined to participate before treatment started, and one participant was not evaluable.
Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=66 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Overall Response
Complete Response
|
53 Participants
|
—
|
—
|
|
Overall Response
Complete Response Unconfirmed
|
10 Participants
|
—
|
—
|
|
Overall Response
Partial Response
|
1 Participants
|
—
|
—
|
|
Overall Response
Non-Responder - Stable Disease
|
1 Participants
|
—
|
—
|
|
Overall Response
Non-Responder - Progressive Disease
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.Population: One participant declined to participate before treatment started, and one participant was not evaluable.
Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy).
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=66 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With Complete Response
|
95 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Participants were followed for up to 10.2 years to determine their response on interim PET scans.Population: 27 participants had no PET scan.
PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=41 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
Interim PET positive participants
|
10.2 years
Interval 0.4 to
Upper end of the CI is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
|
—
|
—
|
|
Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
Interim PET negative participants
|
NA years
Median not reached and confidence intervals cannot be reported because of the timing of the events relative to the follow-up of all participants.
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 27 participants had no PET scan.
1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans. PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=41 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
Interim PET scan positive 1-year PFS
|
61.5 percentage of participants
Interval 30.8 to 81.8
|
—
|
—
|
|
1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
Interim PET scan negative 1 year PFS
|
89.3 percentage of participants
Interval 70.4 to 96.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From the end of chemotherapy every 3 months for the first 2 yearsParticipants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Recovery of CD4 T Cells (CD4) Counts
|
2.5 months
Interval 0.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 monthsThe HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or \< 50 copies.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Recovery of Human Immunodeficiency Virus (HIV) Viral Load
|
2 months
Interval 0.0 to 16.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.Population: One participant declined to participate before treatment started.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 Participants
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
Grade 4
Grade 4 is life threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
|
66 Participants
|
—
|
—
|
Adverse Events
Arm 1-Combination Chemo and Biological Therapy
Serious events: 23 serious events
Other events: 66 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 participants at risk
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
|---|---|
|
General disorders
Abdominal pain or cramping
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Anorexia
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Cardiovascular/Arrhythmia-Other (Asystole)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
CNS hemorrhage/bleeding
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Constitutional Symptoms-Other (Death- Accident/Overdose)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Creatinine
|
1.5%
1/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Dehydration
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Edema
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Febrile neutropenia
|
9.0%
6/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Headache
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage-Other (alveolar)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
metabolism and nutrition disorders
Hypophosphatemia
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Infection without neutropenia
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Neuropathy - motor
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Platelets
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-Other (Myelodysplasia/Leukemia) excludes metastasis from initial primary
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Seizure(s)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Vision-blurred vision
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Vision-photophobia
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
Other adverse events
| Measure |
Arm 1-Combination Chemo and Biological Therapy
n=67 participants at risk
Combination chemo and biological therapy
Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
10.4%
7/67 • Number of events 8 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Confusion
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Conjunctivitis
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Constipation
|
37.3%
25/67 • Number of events 38 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.9%
16/67 • Number of events 19 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Creatinine
|
9.0%
6/67 • Number of events 7 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Dehydration
|
7.5%
5/67 • Number of events 7 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (BACTBRABAN)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Blisters on hands & feet)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Left leg erythema)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Erythema derm other)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
41.8%
28/67 • Number of events 45 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Dizziness/lightheadedness
|
13.4%
9/67 • Number of events 11 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Endocrine disorders
Dry eye
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
7.5%
5/67 • Number of events 6 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.9%
14/67 • Number of events 17 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Ear and labyrinth disorders
Earache (otalgia)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Edema
|
7.5%
5/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
5/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Reproductive system and breast disorders
Erectile impotence
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
47.8%
32/67 • Number of events 57 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Febrile neutropenia
|
25.4%
17/67 • Number of events 21 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
20.9%
14/67 • Number of events 18 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Flatulence
|
7.5%
5/67 • Number of events 6 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Appendicitis-Appendectomy performed)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Fecal incontinence)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Hallucinations
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Headache
|
44.8%
30/67 • Number of events 47 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Hematemesis
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
89.6%
60/67 • Number of events 157 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Hemorrhage-Other (Hemorrhage, GI)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
14.9%
10/67 • Number of events 10 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
32.8%
22/67 • Number of events 34 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
13.4%
9/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.8%
26/67 • Number of events 28 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Amylase
|
4.5%
3/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Anorexia
|
25.4%
17/67 • Number of events 23 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
6.0%
4/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
11.9%
8/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Hepatobiliary disorders
Bilirubin
|
23.9%
16/67 • Number of events 20 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
44.8%
30/67 • Number of events 44 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Cardiovascular/Arrhythmia-Other (Tachycardia)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.3%
29/67 • Number of events 50 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
4/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.9%
8/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Hypertension
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.5%
5/67 • Number of events 6 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.3%
25/67 • Number of events 35 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
37.3%
25/67 • Number of events 31 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.0%
6/67 • Number of events 8 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.9%
16/67 • Number of events 27 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.3%
27/67 • Number of events 44 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.3%
25/67 • Number of events 41 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.9%
14/67 • Number of events 17 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Hypotension
|
10.4%
7/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Incontinence
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Infection
|
28.4%
19/67 • Number of events 26 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Infection without neutropenia
|
31.3%
21/67 • Number of events 39 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Infection with Grade 2 neutropenia)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Insomnia
|
14.9%
10/67 • Number of events 13 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
91.0%
61/67 • Number of events 193 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Metabolism and nutrition disorders
Lipase
|
1.5%
1/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
86.6%
58/67 • Number of events 169 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Memory loss
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Mood alteration-anxiety, agitation
|
4.5%
3/67 • Number of events 6 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Mood alteration-depression
|
11.9%
8/67 • Number of events 10 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
7.5%
5/67 • Number of events 7 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
20.9%
14/67 • Number of events 15 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.5%
5/67 • Number of events 9 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Nausea
|
49.3%
33/67 • Number of events 62 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Neuropathic pain
|
3.0%
2/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Neuropathy-sensory
|
46.3%
31/67 • Number of events 54 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
92.5%
62/67 • Number of events 178 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Back pain)
|
4.5%
3/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Neck pain)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Pain -Other (sacral))
|
1.5%
1/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Pain - Other (lower back))
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Pain-Other (Tooth pain)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Myositis)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Left leg pain_)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Pain-Other (bone marrow (BM) biopsy site)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Pain-Other (pain behind eye)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Pain-Other (Pain at port site)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Pain-Other (Right hip hematoma)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Pain-Other (Epigastric pain)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Leg and back pain)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Back)
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Pain-Other (Generalized)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Pain-Other (Tooth abscess)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Mild left side plank pain)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Palpitations
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Investigations
Partial thromboplastin time (PTT)
|
14.9%
10/67 • Number of events 11 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
4.5%
3/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Platelets
|
83.6%
56/67 • Number of events 138 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.5%
1/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Proctitis
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Investigations
Prothrombin time (PT)
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.4%
9/67 • Number of events 11 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
4.5%
3/67 • Number of events 3 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Rectal or perirectal pain (proctalgia)
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Vaginal blisters)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Rigors, chills
|
9.0%
6/67 • Number of events 7 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Seizure(s)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
46.3%
31/67 • Number of events 54 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
49.3%
33/67 • Number of events 62 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Sinus tachycardia
|
9.0%
6/67 • Number of events 7 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
53.7%
36/67 • Number of events 61 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Sweating (diaphoresis)
|
9.0%
6/67 • Number of events 6 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Nervous system disorders
Syncope (fainting)
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
17.9%
12/67 • Number of events 16 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Tearing (watery eyes)
|
3.0%
2/67 • Number of events 2 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Cardiac disorders
Thrombosis/embolism
|
7.5%
5/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
17.9%
12/67 • Number of events 48 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
37.3%
25/67 • Number of events 69 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Tumor lysis syndrome
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
7.5%
5/67 • Number of events 5 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Vision-blurred vision
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Vision-flashing lights/floaters
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Eye disorders
Vision-photophobia
|
6.0%
4/67 • Number of events 4 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
Gastrointestinal disorders
Vomiting
|
41.8%
28/67 • Number of events 44 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Weight gain
|
1.5%
1/67 • Number of events 1 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
|
General disorders
Weight loss
|
14.9%
10/67 • Number of events 11 • Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place