Trial Outcomes & Findings for S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma (NCT NCT00822120)
NCT ID: NCT00822120
Last Updated: 2022-08-18
Results Overview
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
371 participants
Primary outcome timeframe
2 years
Results posted on
2022-08-18
Participant Flow
Participant milestones
| Measure |
HIV-negative: Initial ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-positive: Initial ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-negative and PET-negative: Continued ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-positive and PET-negative: Continued ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-positive and PET-positive: BEACOPP Standard
Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
|
|---|---|---|---|---|---|---|
|
Initial Registration
STARTED
|
358
|
13
|
0
|
0
|
0
|
0
|
|
Initial Registration
Eligible and Evaluable Patients
|
336
|
12
|
0
|
0
|
0
|
0
|
|
Initial Registration
COMPLETED
|
332
|
12
|
0
|
0
|
0
|
0
|
|
Initial Registration
NOT COMPLETED
|
26
|
1
|
0
|
0
|
0
|
0
|
|
PET-directed Therapy
STARTED
|
0
|
0
|
270
|
55
|
10
|
1
|
|
PET-directed Therapy
Eligibile and Evaluable Patients
|
0
|
0
|
270
|
55
|
10
|
1
|
|
PET-directed Therapy
COMPLETED
|
0
|
0
|
270
|
45
|
10
|
1
|
|
PET-directed Therapy
NOT COMPLETED
|
0
|
0
|
0
|
10
|
0
|
0
|
Reasons for withdrawal
| Measure |
HIV-negative: Initial ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-positive: Initial ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-negative and PET-negative: Continued ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-positive and PET-negative: Continued ABVD
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-positive and PET-positive: BEACOPP Standard
Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
|
|---|---|---|---|---|---|---|
|
Initial Registration
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Initial Registration
Refusal Unrelated to Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Initial Registration
Reasons not Protocol Specified
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Initial Registration
Ineligible
|
22
|
1
|
0
|
0
|
0
|
0
|
|
PET-directed Therapy
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
PET-directed Therapy
Refusal Unrelated to Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
PET-directed Therapy
Death
|
0
|
0
|
0
|
2
|
0
|
0
|
|
PET-directed Therapy
Protocol Violation
|
0
|
0
|
0
|
6
|
0
|
0
|
Baseline Characteristics
S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
HIV-negative: Initial ABVD
n=336 Participants
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-positive: Initial ABVD
n=12 Participants
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 years
n=5 Participants
|
44.6 years
n=7 Participants
|
32.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
189 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
273 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
274 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=336 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
|
—
|
79 percentage of participants
Interval 74.0 to 83.0
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=60 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
|
—
|
64 percentage of participants
Interval 50.0 to 75.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=336 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
|
—
|
98 percentage of participants
Interval 95.0 to 99.0
|
—
|
SECONDARY outcome
Timeframe: 7 months after registrationPopulation: Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=270 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
n=55 Participants
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
|
—
|
100 percentage of patients
Interval 98.6 to 100.0
|
93 percentage of patients
Interval 82.4 to 97.9
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
n=49 Participants
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=336 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
n=270 Participants
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Left ventricular systolic dysfunction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Oral cav
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Musculoskeletal/Soft Tissue-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
38 Participants
|
206 Participants
|
165 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
4 Participants
|
4 Participants
|
12 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Osteonecrosis (avascular necrosis)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Back
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Cardiac/heart
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Chest wall
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Joint
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Muscle
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Oral cavity
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Stomach
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-Other (Specify)
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
34 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-high (hyperkalemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Weight gain
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Vagina
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adult respiratory distress syndrome (ARDS)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Alkaline phosphatase
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction/hypersensitivity
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Arthritis (non-septic)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Carbon monoxide diffusion capacity (DL(co))
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Colitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Colitis, infectious (e.g., Clostridium difficile)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cough
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Creatinine
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cytokine release syndrome/acute infusion reaction
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dizziness
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
1 Participants
|
4 Participants
|
9 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
FEV(1)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
3 Participants
|
10 Participants
|
15 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
17 Participants
|
8 Participants
|
17 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Heartburn/dyspepsia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
37 Participants
|
10 Participants
|
4 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemolysis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, pulmonary/upper respiratory - Nose
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with normal ANC or Grade 1 or 2 neutroph
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Lung (pneumonia)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
42 Participants
|
73 Participants
|
86 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
32 Participants
|
15 Participants
|
30 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Metabolic/Laboratory-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - agitation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - depression
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Bone
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Chest/thorax NOS
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Extremity-limb
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Skin
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Throat/pharynx/larynx
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Tumor pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pancreatic endocrine: glucose intolerance
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rigors/chills
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Syncope (fainting)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vomiting
|
0 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=12 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
|
—
|
83 percentage of patients
Interval 46.0 to 95.0
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=12 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
|
—
|
89 percentage of participants
Interval 43.0 to 98.0
|
—
|
SECONDARY outcome
Timeframe: 7 months after registrationPopulation: Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=10 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
n=1 Participants
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response
|
—
|
9 Participants
|
0 Participants
|
|
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Partial Response
|
—
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
HIV-negative and PET-positive: BEACOPP Escalated
n=1 Participants
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
n=12 Participants
HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
|
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
n=10 Participants
Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
|---|---|---|---|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dizziness
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
1 Participants
|
7 Participants
|
6 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Urinary tract NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Insomnia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - agitation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
1 Participants
|
8 Participants
|
7 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Bone
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Joint
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
HIV-negative: Initial ABVD
Serious events: 1 serious events
Other events: 335 other events
Deaths: 0 deaths
HIV-negative and PET-negative: Continued ABVD
Serious events: 6 serious events
Other events: 268 other events
Deaths: 0 deaths
HIV-negative and PET-positive: BEACOPP Escalated
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
HIV-positive: Initial ABVD
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
HIV-positive and PET-negative: Continued ABVD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HIV-positive and PET-positive: BEACOPP Standard
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-negative: Initial ABVD
n=336 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-negative and PET-negative: Continued ABVD
n=270 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-negative and PET-positive: BEACOPP Escalated
n=49 participants at risk
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-positive: Initial ABVD
n=12 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-positive and PET-negative: Continued ABVD
n=10 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-positive and PET-positive: BEACOPP Standard
n=1 participants at risk
Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Mood alteration - agitation
|
0.30%
1/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Mood alteration - depression
|
0.30%
1/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
Other adverse events
| Measure |
HIV-negative: Initial ABVD
n=336 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-negative and PET-negative: Continued ABVD
n=270 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-negative and PET-positive: BEACOPP Escalated
n=49 participants at risk
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
|
HIV-positive: Initial ABVD
n=12 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
|
HIV-positive and PET-negative: Continued ABVD
n=10 participants at risk
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
|
HIV-positive and PET-positive: BEACOPP Standard
n=1 participants at risk
Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
8/336 • Up to 1 year
|
6.3%
17/270 • Up to 1 year
|
32.7%
16/49 • Up to 1 year
|
25.0%
3/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.9%
171/336 • Up to 1 year
|
59.6%
161/270 • Up to 1 year
|
89.8%
44/49 • Up to 1 year
|
50.0%
6/12 • Up to 1 year
|
70.0%
7/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Cardiac disorders
Palpitations
|
0.60%
2/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
2.1%
7/336 • Up to 1 year
|
3.3%
9/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Eye disorders
Ocular/Visual-Other
|
3.0%
10/336 • Up to 1 year
|
5.6%
15/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.9%
114/336 • Up to 1 year
|
27.0%
73/270 • Up to 1 year
|
20.4%
10/49 • Up to 1 year
|
41.7%
5/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Dental: teeth
|
0.30%
1/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.1%
34/336 • Up to 1 year
|
14.8%
40/270 • Up to 1 year
|
30.6%
15/49 • Up to 1 year
|
25.0%
3/12 • Up to 1 year
|
50.0%
5/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.60%
2/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
4/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
1.2%
4/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
8.3%
28/336 • Up to 1 year
|
11.1%
30/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
10.7%
36/336 • Up to 1 year
|
9.3%
25/270 • Up to 1 year
|
26.5%
13/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
8.0%
27/336 • Up to 1 year
|
4.4%
12/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
60.4%
203/336 • Up to 1 year
|
64.1%
173/270 • Up to 1 year
|
59.2%
29/49 • Up to 1 year
|
33.3%
4/12 • Up to 1 year
|
60.0%
6/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
9.5%
32/336 • Up to 1 year
|
10.4%
28/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
4.2%
14/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
20.2%
68/336 • Up to 1 year
|
27.4%
74/270 • Up to 1 year
|
38.8%
19/49 • Up to 1 year
|
25.0%
3/12 • Up to 1 year
|
40.0%
4/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
General disorders
Edema: limb
|
3.9%
13/336 • Up to 1 year
|
7.8%
21/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.4%
203/336 • Up to 1 year
|
70.7%
191/270 • Up to 1 year
|
73.5%
36/49 • Up to 1 year
|
41.7%
5/12 • Up to 1 year
|
70.0%
7/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
7.1%
24/336 • Up to 1 year
|
13.0%
35/270 • Up to 1 year
|
20.4%
10/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
General disorders
Pain - Chest/thorax NOS
|
5.1%
17/336 • Up to 1 year
|
5.6%
15/270 • Up to 1 year
|
14.3%
7/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
General disorders
Pain-Other
|
7.1%
24/336 • Up to 1 year
|
10.7%
29/270 • Up to 1 year
|
14.3%
7/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
General disorders
Rigors/chills
|
6.0%
20/336 • Up to 1 year
|
6.3%
17/270 • Up to 1 year
|
22.4%
11/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
40.0%
4/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
General disorders
Syndromes-Other
|
0.00%
0/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
1.5%
5/336 • Up to 1 year
|
2.2%
6/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
0.60%
2/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.30%
1/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
0.30%
1/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
0.30%
1/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Infection with unknown ANC - Ureter
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
0.30%
1/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Infections and infestations
Infection-Other
|
1.8%
6/336 • Up to 1 year
|
5.2%
14/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
0.60%
2/336 • Up to 1 year
|
1.1%
3/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
20.2%
68/336 • Up to 1 year
|
18.1%
49/270 • Up to 1 year
|
26.5%
13/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
40.0%
4/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
AST, SGOT
|
16.4%
55/336 • Up to 1 year
|
15.2%
41/270 • Up to 1 year
|
18.4%
9/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
40.0%
4/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Alkaline phosphatase
|
11.3%
38/336 • Up to 1 year
|
5.2%
14/270 • Up to 1 year
|
14.3%
7/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.89%
3/336 • Up to 1 year
|
1.5%
4/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
CD4 count
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
0.00%
0/336 • Up to 1 year
|
2.6%
7/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Creatinine
|
3.6%
12/336 • Up to 1 year
|
3.3%
9/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Investigations
Leukocytes (total WBC)
|
63.1%
212/336 • Up to 1 year
|
69.6%
188/270 • Up to 1 year
|
91.8%
45/49 • Up to 1 year
|
58.3%
7/12 • Up to 1 year
|
60.0%
6/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Investigations
Lipase
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Lymphopenia
|
23.8%
80/336 • Up to 1 year
|
34.8%
94/270 • Up to 1 year
|
65.3%
32/49 • Up to 1 year
|
33.3%
4/12 • Up to 1 year
|
60.0%
6/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Investigations
Metabolic/Laboratory-Other
|
3.3%
11/336 • Up to 1 year
|
2.6%
7/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
74.4%
250/336 • Up to 1 year
|
78.9%
213/270 • Up to 1 year
|
83.7%
41/49 • Up to 1 year
|
75.0%
9/12 • Up to 1 year
|
70.0%
7/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Investigations
PTT (Partial thromboplastin time)
|
0.89%
3/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Platelets
|
5.7%
19/336 • Up to 1 year
|
8.5%
23/270 • Up to 1 year
|
89.8%
44/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Investigations
Weight gain
|
5.4%
18/336 • Up to 1 year
|
9.6%
26/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Investigations
Weight loss
|
3.3%
11/336 • Up to 1 year
|
4.4%
12/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
10.7%
36/336 • Up to 1 year
|
13.0%
35/270 • Up to 1 year
|
26.5%
13/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
42/336 • Up to 1 year
|
17.4%
47/270 • Up to 1 year
|
26.5%
13/49 • Up to 1 year
|
25.0%
3/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
8.9%
30/336 • Up to 1 year
|
11.9%
32/270 • Up to 1 year
|
32.7%
16/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
6/336 • Up to 1 year
|
3.7%
10/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
20.5%
69/336 • Up to 1 year
|
30.4%
82/270 • Up to 1 year
|
46.9%
23/49 • Up to 1 year
|
33.3%
4/12 • Up to 1 year
|
50.0%
5/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
1.8%
6/336 • Up to 1 year
|
3.3%
9/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
1.5%
5/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.60%
2/336 • Up to 1 year
|
1.9%
5/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
1.8%
6/336 • Up to 1 year
|
2.6%
7/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.6%
12/336 • Up to 1 year
|
7.0%
19/270 • Up to 1 year
|
44.9%
22/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.7%
19/336 • Up to 1 year
|
6.7%
18/270 • Up to 1 year
|
20.4%
10/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.30%
1/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
1.2%
4/336 • Up to 1 year
|
2.6%
7/270 • Up to 1 year
|
12.2%
6/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
8.0%
27/336 • Up to 1 year
|
8.9%
24/270 • Up to 1 year
|
18.4%
9/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.7%
19/336 • Up to 1 year
|
8.1%
22/270 • Up to 1 year
|
44.9%
22/49 • Up to 1 year
|
25.0%
3/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
2.1%
7/336 • Up to 1 year
|
2.2%
6/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
5.4%
18/336 • Up to 1 year
|
7.8%
21/270 • Up to 1 year
|
12.2%
6/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
9.2%
31/336 • Up to 1 year
|
11.1%
30/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
11.6%
39/336 • Up to 1 year
|
16.7%
45/270 • Up to 1 year
|
18.4%
9/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
8.9%
30/336 • Up to 1 year
|
9.3%
25/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Nervous system disorders
Neuropathy: motor
|
2.7%
9/336 • Up to 1 year
|
5.2%
14/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Nervous system disorders
Neuropathy: sensory
|
25.3%
85/336 • Up to 1 year
|
38.1%
103/270 • Up to 1 year
|
63.3%
31/49 • Up to 1 year
|
50.0%
6/12 • Up to 1 year
|
50.0%
5/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Nervous system disorders
Ocular/Visual-Other
|
3.0%
10/336 • Up to 1 year
|
5.6%
15/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Nervous system disorders
Pain - Head/headache
|
14.0%
47/336 • Up to 1 year
|
14.8%
40/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
33.3%
4/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
11.3%
38/336 • Up to 1 year
|
13.0%
35/270 • Up to 1 year
|
16.3%
8/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
13.1%
44/336 • Up to 1 year
|
17.8%
48/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Libido
|
0.00%
0/336 • Up to 1 year
|
0.00%
0/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Mood alteration - agitation
|
0.30%
1/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Mood alteration - anxiety
|
6.2%
21/336 • Up to 1 year
|
9.3%
25/270 • Up to 1 year
|
16.3%
8/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Psychiatric disorders
Mood alteration - depression
|
3.3%
11/336 • Up to 1 year
|
5.2%
14/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
0.60%
2/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Renal and urinary disorders
Pain - Urethra
|
0.30%
1/336 • Up to 1 year
|
0.37%
1/270 • Up to 1 year
|
2.0%
1/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
1.5%
5/336 • Up to 1 year
|
2.2%
6/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.6%
12/336 • Up to 1 year
|
8.9%
24/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
0.00%
0/336 • Up to 1 year
|
2.6%
7/270 • Up to 1 year
|
0.00%
0/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.1%
44/336 • Up to 1 year
|
26.7%
72/270 • Up to 1 year
|
26.5%
13/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.7%
56/336 • Up to 1 year
|
25.9%
70/270 • Up to 1 year
|
34.7%
17/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
0.60%
2/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
10.2%
5/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
5.7%
19/336 • Up to 1 year
|
6.3%
17/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.89%
3/336 • Up to 1 year
|
4.4%
12/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
1.5%
5/336 • Up to 1 year
|
5.9%
16/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.60%
2/336 • Up to 1 year
|
0.74%
2/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
4.2%
14/336 • Up to 1 year
|
5.6%
15/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
23.8%
80/336 • Up to 1 year
|
35.9%
97/270 • Up to 1 year
|
32.7%
16/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
30.0%
3/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.3%
11/336 • Up to 1 year
|
6.7%
18/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.7%
9/336 • Up to 1 year
|
11.9%
32/270 • Up to 1 year
|
8.2%
4/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.2%
21/336 • Up to 1 year
|
7.4%
20/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.2%
41/336 • Up to 1 year
|
17.8%
48/270 • Up to 1 year
|
18.4%
9/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.8%
6/336 • Up to 1 year
|
3.3%
9/270 • Up to 1 year
|
6.1%
3/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
9.2%
31/336 • Up to 1 year
|
12.2%
33/270 • Up to 1 year
|
24.5%
12/49 • Up to 1 year
|
16.7%
2/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
100.0%
1/1 • Up to 1 year
|
|
Vascular disorders
Hot flashes/flushes
|
2.1%
7/336 • Up to 1 year
|
6.3%
17/270 • Up to 1 year
|
14.3%
7/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
1.2%
4/336 • Up to 1 year
|
2.2%
6/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
20.0%
2/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
1.8%
6/336 • Up to 1 year
|
1.9%
5/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
1.5%
5/336 • Up to 1 year
|
3.3%
9/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
8.3%
1/12 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.8%
6/336 • Up to 1 year
|
3.0%
8/270 • Up to 1 year
|
4.1%
2/49 • Up to 1 year
|
0.00%
0/12 • Up to 1 year
|
10.0%
1/10 • Up to 1 year
|
0.00%
0/1 • Up to 1 year
|
Additional Information
Lymphoma Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place