Trial Outcomes & Findings for S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma (NCT NCT00770224)
NCT ID: NCT00770224
Last Updated: 2019-08-28
Results Overview
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
0-3 years
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
R-CHOP+I-131 Tositumomab
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Step 1: Induction
STARTED
|
87
|
0
|
|
Step 1: Induction
Eligible and Evaluable
|
84
|
0
|
|
Step 1: Induction
COMPLETED
|
73
|
0
|
|
Step 1: Induction
NOT COMPLETED
|
14
|
0
|
|
Step 2: Maintenance
STARTED
|
0
|
71
|
|
Step 2: Maintenance
Eligible and Evaluable
|
0
|
69
|
|
Step 2: Maintenance
COMPLETED
|
0
|
41
|
|
Step 2: Maintenance
NOT COMPLETED
|
0
|
30
|
Reasons for withdrawal
| Measure |
R-CHOP+I-131 Tositumomab
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Step 1: Induction
Adverse Event
|
3
|
0
|
|
Step 1: Induction
Refusal unrelated to adverse event
|
6
|
0
|
|
Step 1: Induction
Other reason not protocol specified
|
2
|
0
|
|
Step 1: Induction
Ineligible
|
2
|
0
|
|
Step 1: Induction
No protocol treatment given
|
1
|
0
|
|
Step 2: Maintenance
Adverse Event
|
0
|
10
|
|
Step 2: Maintenance
Refusal unrelated to adverse event
|
0
|
8
|
|
Step 2: Maintenance
Progression/relapse
|
0
|
1
|
|
Step 2: Maintenance
Death
|
0
|
2
|
|
Step 2: Maintenance
Other reason not protocol specified
|
0
|
7
|
|
Step 2: Maintenance
Ineligible
|
0
|
2
|
Baseline Characteristics
S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
R-CHOP+I-131 Tositumomab
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
|
|---|---|
|
Age, Continuous
|
52.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-3 yearsPopulation: Eligible and evaluable patients were included in the analysis.
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
Outcome measures
| Measure |
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Percentage of Participants With 3-year Progression-free Survival (PFS)
|
90 percentage of participants
Interval 81.9 to 95.1
|
—
|
SECONDARY outcome
Timeframe: 0-5 yearsPopulation: Eligible and evaluable patients were included in the analysis.
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
Outcome measures
| Measure |
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
5-year Progression-free Survival
|
85 percentage of participants
Interval 74.8 to 90.7
|
—
|
SECONDARY outcome
Timeframe: 0-5 yearsPopulation: Eligible and evaluable patients were included in the analysis.
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 |
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
5-year Overall Survival
|
94 percentage of participants
Interval 86.3 to 97.5
|
—
|
SECONDARY outcome
Timeframe: up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progressionPopulation: Eligible and evaluable patients were included in the analysis.
Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of the following. Positron emission tomography (PET) must be negative if no pre-treatment PET scan or when the PET was positive before therapy. If the PET scan was negative before therapy, all nodal masses must have regressed. no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. PR is ≥ 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. In patients with no pre-treatment 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 |
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
Rituximab Maintenance
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Response Rate
Complete Response
|
61 Participants
|
—
|
|
Response Rate
Patital Response
|
22 Participants
|
—
|
|
Response Rate
Assessment Inadequate
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.Population: Eligible 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 |
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
n=84 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
Rituximab Maintenance
n=69 Participants
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction/hypersensitivity
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cough
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Enteritis (inflammation of the small bowel)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
8 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
14 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
6 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Bladder
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
0 Participants
|
|
Number of 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
|
|
Number of 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
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Wound
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Left ventricular systolic dysfunction
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
34 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
25 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - depression
|
0 Participants
|
1 Participants
|
|
Number of 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
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nasal cavity/paranasal sinus reactions
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
6 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
48 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Bone
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Muscle
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-Other (Specify)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
17 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pulmonary hypertension
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Restrictive cardiomyopathy
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Secondary Malignancy-poss rel to cancer Tx
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Syncope (fainting)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Valvular heart disease
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vasovagal episode
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vision-blurred vision
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vomiting
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Weight loss
|
1 Participants
|
0 Participants
|
Adverse Events
R-CHOP+I-131 Tositumomab
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Rituximab Maintenance
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-CHOP+I-131 Tositumomab
n=84 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
|
Rituximab Maintenance
n=69 participants at risk
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-poss rel to cancer Tx
|
0.00%
0/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
1.4%
1/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
Other adverse events
| Measure |
R-CHOP+I-131 Tositumomab
n=84 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.
|
Rituximab Maintenance
n=69 participants at risk
Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.9%
15/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
0.00%
0/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
56/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
26.1%
18/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.2%
1/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Cardiac disorders
Palpitations
|
2.4%
2/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Endocrine disorders
Thyroid function, high
|
0.00%
0/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.4%
2/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
10.1%
7/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Eye disorders
Vision-blurred vision
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Constipation
|
47.6%
40/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
13.0%
9/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
18/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
21.7%
15/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
17.9%
15/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
0.00%
0/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
11.9%
10/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
2.9%
2/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Nausea
|
69.0%
58/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
23.2%
16/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
27.4%
23/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
21/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
General disorders
Edema: limb
|
14.3%
12/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
10.1%
7/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
83.3%
70/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
60.9%
42/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
4.3%
3/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
General disorders
Pain-Other
|
10.7%
9/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
20.3%
14/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
General disorders
Rigors/chills
|
17.9%
15/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
2.9%
2/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
16.7%
14/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
2.9%
2/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
|
0.00%
0/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
0.00%
0/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
17.4%
12/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
3.6%
3/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
0.00%
0/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
13.0%
9/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Infections and infestations
Infection-Other
|
4.8%
4/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
10.1%
7/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
17.9%
15/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
15.9%
11/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
AST, SGOT
|
16.7%
14/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Alkaline phosphatase
|
10.7%
9/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
4.8%
4/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
11.6%
8/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Creatinine
|
9.5%
8/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Leukocytes (total WBC)
|
71.4%
60/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
44.9%
31/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Lymphopenia
|
42.9%
36/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
46.4%
32/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Metabolic/Laboratory-Other
|
11.9%
10/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
66.7%
56/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
13.0%
9/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Platelets
|
69.0%
58/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
37.7%
26/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Weight gain
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Investigations
Weight loss
|
9.5%
8/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
13.0%
9/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
16.7%
14/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Anorexia
|
29.8%
25/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
11.6%
8/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
14.3%
12/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
8.7%
6/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
2.9%
2/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
41.7%
35/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
31.9%
22/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
0.00%
0/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.0%
5/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
14.3%
12/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
10.1%
7/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.5%
13/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
6.0%
5/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
1.4%
1/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
11.9%
10/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
4.3%
3/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
14.3%
12/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
15.9%
11/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
13.1%
11/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
8.7%
6/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
15.5%
13/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
26.1%
18/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
19.0%
16/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
15.9%
11/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Nervous system disorders
Dizziness
|
17.9%
15/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
11.6%
8/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Nervous system disorders
Neuropathy: sensory
|
57.1%
48/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
21.7%
15/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Nervous system disorders
Pain - Head/headache
|
28.6%
24/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
11.6%
8/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
19.0%
16/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
0.00%
0/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Psychiatric disorders
Insomnia
|
28.6%
24/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
18.8%
13/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
21.4%
18/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Psychiatric disorders
Mood alteration - depression
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
20.3%
14/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.7%
9/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
18/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
30.4%
21/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
22.6%
19/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
11.6%
8/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
5.8%
4/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
3.6%
3/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
13.0%
9/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
4.8%
4/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
54.8%
46/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
4.3%
3/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.0%
5/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
4.3%
3/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.1%
6/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
1.4%
1/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.5%
8/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
7.2%
5/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.0%
5/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
2.9%
2/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
15.5%
13/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Vascular disorders
Hot flashes/flushes
|
10.7%
9/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Vascular disorders
Hypertension
|
3.6%
3/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
14.5%
10/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
|
Vascular disorders
Hypotension
|
8.3%
7/84 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
0.00%
0/69 • up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
|
Additional Information
Lymphoma Committee Statistician
SWOG Statistics and Data Management Center
Phone: 206-667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60