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S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00770224
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : November 15, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Biological: tositumomab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: vincristine
Radiation: tositumomab
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title R-CHOP+I-131 Tositumomab Rituximab Maintenance
Hide Arm/Group Description

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.
Period Title: Step 1: Induction
Started 87 0
Eligible and Evaluable 84 0
Completed 73 0
Not Completed 14 0
Reason Not Completed
Adverse Event             3             0
Refusal unrelated to adverse event             6             0
Other reason not protocol specified             2             0
Ineligible             2             0
No protocol treatment given             1             0
Period Title: Step 2: Maintenance
Started 0 71
Eligible and Evaluable 0 69
Completed 0 41
Not Completed 0 30
Reason Not Completed
Adverse Event             0             10
Refusal unrelated to adverse event             0             8
Progression/relapse             0             1
Death             0             2
Other reason not protocol specified             0             7
Ineligible             0             2
Arm/Group Title R-CHOP+I-131 Tositumomab
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 84
Hide Baseline Analysis Population Description
Only eligible and evaluable patients were included in the analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants
52.3
(28.9 to 79.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
Female
44
  52.4%
Male
40
  47.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
Hispanic or Latino
2
   2.4%
Not Hispanic or Latino
81
  96.4%
Unknown or Not Reported
1
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.2%
Black or African American
3
   3.6%
White
78
  92.9%
More than one race
0
   0.0%
Unknown or Not Reported
2
   2.4%
1.Primary Outcome
Title Percentage of Participants With 3-year Progression-free Survival (PFS)
Hide Description 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.
Time Frame 0-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients were included in the analysis.
Arm/Group Title R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90
(81.9 to 95.1)
2.Secondary Outcome
Title 5-year Progression-free Survival
Hide Description 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.
Time Frame 0-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients were included in the analysis.
Arm/Group Title R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(74.8 to 90.7)
3.Secondary Outcome
Title 5-year Overall Survival
Hide Description 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.
Time Frame 0-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients were included in the analysis.
Arm/Group Title R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94
(86.3 to 97.5)
4.Secondary Outcome
Title Response Rate
Hide Description 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.
Time Frame up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients were included in the analysis.
Arm/Group Title R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 84
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
61
  72.6%
Patital Response
22
  26.2%
Assessment Inadequate
1
   1.2%
5.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description 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.
Time Frame up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title R-CHOP+I-131 Tositumomab Rituximab Maintenance
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 84 69
Measure Type: Number
Unit of Measure: Participants
Albumin, serum-low (hypoalbuminemia) 1 0
Allergic reaction/hypersensitivity 2 0
Anorexia 1 0
Cough 1 1
Diarrhea 1 0
Dyspnea (shortness of breath) 1 0
Enteritis (inflammation of the small bowel) 0 1
Fatigue (asthenia, lethargy, malaise) 8 1
Febrile neutropenia 14 0
Fever in absence of neutropenia, ANC lt1.0x10e9/L 2 0
Glucose, serum-high (hyperglycemia) 4 0
Hemoglobin 6 0
Hypotension 2 0
Inf (clin/microbio) w/Gr 3-4 neuts - Bladder 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic 2 0
Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Wound 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus 0 1
Left ventricular systolic dysfunction 1 1
Leukocytes (total WBC) 34 0
Lymphopenia 25 4
Mood alteration - anxiety 0 1
Mood alteration - depression 0 1
Muscle weakness, not d/t neuropathy - body/general 1 1
Nasal cavity/paranasal sinus reactions 0 1
Nausea 3 0
Neuropathy: motor 1 0
Neuropathy: sensory 6 0
Neutrophils/granulocytes (ANC/AGC) 48 1
Opportunistic inf associated w/gt=Gr 2 lymphopenia 1 0
Pain - Abdomen NOS 1 0
Pain - Bone 1 0
Pain - Head/headache 1 0
Pain - Muscle 1 0
Pain-Other (Specify) 0 1
Platelets 17 0
Pulmonary hypertension 0 1
Restrictive cardiomyopathy 0 1
Secondary Malignancy-poss rel to cancer Tx 0 1
Sodium, serum-low (hyponatremia) 1 0
Syncope (fainting) 1 0
Thrombosis/thrombus/embolism 1 0
Valvular heart disease 0 1
Vasovagal episode 0 1
Vision-blurred vision 1 0
Vomiting 2 0
Weight loss 1 0
Time Frame up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title R-CHOP+I-131 Tositumomab Rituximab Maintenance
Hide Arm/Group Description

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.
All-Cause Mortality
R-CHOP+I-131 Tositumomab Rituximab Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/69 (0.00%) 
Hide Serious Adverse Events
R-CHOP+I-131 Tositumomab Rituximab Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy-poss rel to cancer Tx  1  0/84 (0.00%)  1/69 (1.45%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
R-CHOP+I-131 Tositumomab Rituximab Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   84/84 (100.00%)   66/69 (95.65%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  15/84 (17.86%)  0/69 (0.00%) 
Hemoglobin  1  56/84 (66.67%)  18/69 (26.09%) 
Cardiac disorders     
Left ventricular systolic dysfunction  1  1/84 (1.19%)  4/69 (5.80%) 
Palpitations  1  2/84 (2.38%)  4/69 (5.80%) 
Endocrine disorders     
Thyroid function, high  1  0/84 (0.00%)  4/69 (5.80%) 
Thyroid function, low (hypothyroidism)  1  2/84 (2.38%)  7/69 (10.14%) 
Eye disorders     
Vision-blurred vision  1  6/84 (7.14%)  4/69 (5.80%) 
Gastrointestinal disorders     
Constipation  1  40/84 (47.62%)  9/69 (13.04%) 
Diarrhea  1  18/84 (21.43%)  15/69 (21.74%) 
Heartburn/dyspepsia  1  15/84 (17.86%)  5/69 (7.25%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  6/84 (7.14%)  0/69 (0.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  10/84 (11.90%)  2/69 (2.90%) 
Nausea  1  58/84 (69.05%)  16/69 (23.19%) 
Pain - Abdomen NOS  1  23/84 (27.38%)  10/69 (14.49%) 
Vomiting  1  21/84 (25.00%)  5/69 (7.25%) 
General disorders     
Edema: limb  1  12/84 (14.29%)  7/69 (10.14%) 
Fatigue (asthenia, lethargy, malaise)  1  70/84 (83.33%)  42/69 (60.87%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  7/84 (8.33%)  3/69 (4.35%) 
Pain-Other  1  9/84 (10.71%)  14/69 (20.29%) 
Rigors/chills  1  15/84 (17.86%)  2/69 (2.90%) 
Immune system disorders     
Allergic reaction/hypersensitivity  1  14/84 (16.67%)  2/69 (2.90%) 
Infections and infestations     
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus  1  0/84 (0.00%)  4/69 (5.80%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus  1  0/84 (0.00%)  12/69 (17.39%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  3/84 (3.57%)  5/69 (7.25%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  7/84 (8.33%)  4/69 (5.80%) 
Infection with unknown ANC - Sinus  1  0/84 (0.00%)  9/69 (13.04%) 
Infection-Other  1  4/84 (4.76%)  7/69 (10.14%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  15/84 (17.86%)  11/69 (15.94%) 
AST, SGOT  1  14/84 (16.67%)  10/69 (14.49%) 
Alkaline phosphatase  1  9/84 (10.71%)  5/69 (7.25%) 
Bilirubin (hyperbilirubinemia)  1  4/84 (4.76%)  8/69 (11.59%) 
Creatinine  1  8/84 (9.52%)  10/69 (14.49%) 
Leukocytes (total WBC)  1  60/84 (71.43%)  31/69 (44.93%) 
Lymphopenia  1  36/84 (42.86%)  32/69 (46.38%) 
Metabolic/Laboratory-Other  1  10/84 (11.90%)  10/69 (14.49%) 
Neutrophils/granulocytes (ANC/AGC)  1  56/84 (66.67%)  9/69 (13.04%) 
Platelets  1  58/84 (69.05%)  26/69 (37.68%) 
Weight gain  1  7/84 (8.33%)  10/69 (14.49%) 
Weight loss  1  8/84 (9.52%)  9/69 (13.04%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  14/84 (16.67%)  5/69 (7.25%) 
Anorexia  1  25/84 (29.76%)  8/69 (11.59%) 
Calcium, serum-low (hypocalcemia)  1  12/84 (14.29%)  6/69 (8.70%) 
Dehydration  1  6/84 (7.14%)  2/69 (2.90%) 
Glucose, serum-high (hyperglycemia)  1  35/84 (41.67%)  22/69 (31.88%) 
Glucose, serum-low (hypoglycemia)  1  6/84 (7.14%)  4/69 (5.80%) 
Magnesium, serum-low (hypomagnesemia)  1  7/84 (8.33%)  0/69 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  5/84 (5.95%)  4/69 (5.80%) 
Potassium, serum-low (hypokalemia)  1  12/84 (14.29%)  7/69 (10.14%) 
Sodium, serum-low (hyponatremia)  1  13/84 (15.48%)  5/69 (7.25%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, not d/t neuropathy - Extrem-lower  1  5/84 (5.95%)  1/69 (1.45%) 
Muscle weakness, not d/t neuropathy - body/general  1  10/84 (11.90%)  3/69 (4.35%) 
Pain - Back  1  12/84 (14.29%)  11/69 (15.94%) 
Pain - Bone  1  11/84 (13.10%)  4/69 (5.80%) 
Pain - Extremity-limb  1  6/84 (7.14%)  6/69 (8.70%) 
Pain - Joint  1  13/84 (15.48%)  18/69 (26.09%) 
Pain - Muscle  1  16/84 (19.05%)  11/69 (15.94%) 
Nervous system disorders     
Dizziness  1  15/84 (17.86%)  8/69 (11.59%) 
Neuropathy: sensory  1  48/84 (57.14%)  15/69 (21.74%) 
Pain - Head/headache  1  24/84 (28.57%)  8/69 (11.59%) 
Taste alteration (dysgeusia)  1  16/84 (19.05%)  0/69 (0.00%) 
Psychiatric disorders     
Insomnia  1  24/84 (28.57%)  13/69 (18.84%) 
Mood alteration - anxiety  1  18/84 (21.43%)  10/69 (14.49%) 
Mood alteration - depression  1  7/84 (8.33%)  14/69 (20.29%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  9/84 (10.71%)  10/69 (14.49%) 
Cough  1  18/84 (21.43%)  21/69 (30.43%) 
Dyspnea (shortness of breath)  1  19/84 (22.62%)  8/69 (11.59%) 
Pain - Throat/pharynx/larynx  1  6/84 (7.14%)  4/69 (5.80%) 
Pulmonary/Upper Respiratory-Other  1  3/84 (3.57%)  9/69 (13.04%) 
Skin and subcutaneous tissue disorders     
Dermatology/Skin-Other  1  4/84 (4.76%)  5/69 (7.25%) 
Hair loss/Alopecia (scalp or body)  1  46/84 (54.76%)  3/69 (4.35%) 
Nail changes  1  5/84 (5.95%)  3/69 (4.35%) 
Pruritus/itching  1  6/84 (7.14%)  1/69 (1.45%) 
Rash/desquamation  1  8/84 (9.52%)  5/69 (7.25%) 
Rash: acne/acneiform  1  5/84 (5.95%)  2/69 (2.90%) 
Sweating (diaphoresis)  1  13/84 (15.48%)  10/69 (14.49%) 
Vascular disorders     
Hot flashes/flushes  1  9/84 (10.71%)  10/69 (14.49%) 
Hypertension  1  3/84 (3.57%)  10/69 (14.49%) 
Hypotension  1  7/84 (8.33%)  0/69 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 206-667-4623
EMail: lymph@crab.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00770224    
Other Study ID Numbers: CDR0000615104
S0801 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: June 27, 2018
Results First Posted: November 15, 2018
Last Update Posted: August 28, 2019