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Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

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: NCT00039130
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 22, 2014
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: methotrexate
Drug: prednisone
Drug: vincristine sulfate
Drug: Allopurinol
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab With High Intensity Chemotherapy
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Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

Period Title: Overall Study
Started 105
Completed 75
Not Completed 30
Reason Not Completed
Adverse Event             11
Death             9
Withdrawal by Subject             3
Progression             2
Subsequent treatment             2
Physician Decision             3
Arm/Group Title Rituximab With High Intensity Chemotherapy
Hide Arm/Group Description

Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 105 participants
43
(19 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
32
  30.5%
Male
73
  69.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   4.8%
White
98
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants
105
1.Primary Outcome
Title Complete Response Rate
Hide Description Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Time Frame 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab With High Intensity Chemotherapy
Hide Arm/Group Description:

Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83
(74 to 90)
2.Secondary Outcome
Title 2 Year Event Free Survival
Hide Description Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab With High Intensity Chemotherapy
Hide Arm/Group Description:

Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78
(69 to 85)
3.Secondary Outcome
Title 2 Year Overall Survival
Hide Description Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab With High Intensity Chemotherapy
Hide Arm/Group Description:

Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80
(71 to 86)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab With High Intensity Chemotherapy
Hide Arm/Group Description

Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)

Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)

Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)

All-Cause Mortality
Rituximab With High Intensity Chemotherapy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rituximab With High Intensity Chemotherapy
Affected / at Risk (%) # Events
Total   61/105 (58.10%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  31/105 (29.52%)  40
Hemoglobin decreased  1  58/105 (55.24%)  81
Lymphatic disorder  1  2/105 (1.90%)  2
Lymphatics  1  1/105 (0.95%)  1
Transfusion: Platelets  1  3/105 (2.86%)  3
Transfusion: pRBCs  1  5/105 (4.76%)  6
Cardiac disorders   
Arrhythmia  1  4/105 (3.81%)  4
Arrhythmia supraventricular  1  4/105 (3.81%)  4
Cardiac disorder  1  3/105 (2.86%)  3
Conduction disorder  1  2/105 (1.90%)  2
Edema  1  20/105 (19.05%)  21
Left ventricular failure  1  4/105 (3.81%)  4
Myocardial ischemia  1  1/105 (0.95%)  1
Myocarditis  1  1/105 (0.95%)  1
Nodal arrhythmia  1  1/105 (0.95%)  1
Pericardial effusion  1  3/105 (2.86%)  3
Sinus bradycardia  1  2/105 (1.90%)  2
Sinus tachycardia  1  11/105 (10.48%)  13
Ventricular arrhythmia  1  2/105 (1.90%)  2
Ear and labyrinth disorders   
Ear disorder  1  2/105 (1.90%)  2
Ear pain  1  1/105 (0.95%)  1
Endocrine disorders   
Cushingoid  1  1/105 (0.95%)  1
Eye disorders   
Eye disorder  1  1/105 (0.95%)  1
Photophobia  1  1/105 (0.95%)  1
Vision blurred  1  4/105 (3.81%)  4
Gastrointestinal disorders   
Abdominal distension  1  1/105 (0.95%)  1
Abdominal pain  1  12/105 (11.43%)  13
Anal fistula  1  1/105 (0.95%)  1
Anal pain  1  1/105 (0.95%)  1
Ascites  1  4/105 (3.81%)  5
Colitis  1  2/105 (1.90%)  2
Constipation  1  14/105 (13.33%)  15
Diarrhea  1  27/105 (25.71%)  30
Dyspepsia  1  2/105 (1.90%)  2
Esophagitis  1  28/105 (26.67%)  34
Flatulence  1  2/105 (1.90%)  2
Gastric ulcer  1  2/105 (1.90%)  2
Gastritis  1  1/105 (0.95%)  1
Gastrointestinal disorder  1  2/105 (1.90%)  2
Gingival pain  1  1/105 (0.95%)  1
Hematemesis  1  1/105 (0.95%)  1
Hemorrhoids  1  2/105 (1.90%)  2
Ileus  1  3/105 (2.86%)  3
Melena/GI bleeding  1  2/105 (1.90%)  2
Mucositis oral  1  45/105 (42.86%)  59
Nausea  1  32/105 (30.48%)  41
Oral pain  1  4/105 (3.81%)  4
Proctitis  1  1/105 (0.95%)  1
Rectal bleeding/hematochezia  1  5/105 (4.76%)  6
Rectal pain  1  2/105 (1.90%)  4
Typhlitis  1  1/105 (0.95%)  1
Vomiting  1  22/105 (20.95%)  25
General disorders   
Chest pain  1  3/105 (2.86%)  3
Chills  1  10/105 (9.52%)  12
Edema limbs  1  4/105 (3.81%)  4
Fatigue  1  31/105 (29.52%)  37
Fever  1  11/105 (10.48%)  11
General symptom  1  1/105 (0.95%)  1
Pain  1  24/105 (22.86%)  27
Hepatobiliary disorders   
Cholecystitis  1  2/105 (1.90%)  2
Hepatic failure  1  1/105 (0.95%)  1
Hepatobiliary disease  1  1/105 (0.95%)  1
Immune system disorders   
Hypersensitivity  1  1/105 (0.95%)  1
Infections and infestations   
Anal infection  1  1/105 (0.95%)  1
Catheter related infection  1  4/105 (3.81%)  4
Infection  1  1/105 (0.95%)  1
Infection with grade 3 or 4 neutropenia  1  32/105 (30.48%)  36
Infection with unknown ANC  1  1/105 (0.95%)  1
Infection without neutropenia  1  19/105 (18.10%)  20
Infectious colitis  1  1/105 (0.95%)  1
Pneumonia  1  1/105 (0.95%)  1
Skin infection  1  1/105 (0.95%)  1
Urinary tract infection  1  1/105 (0.95%)  1
Wound-infectious  1  2/105 (1.90%)  2
Injury, poisoning and procedural complications   
Dermatitis radiation  1  1/105 (0.95%)  1
Vascular access complication  1  1/105 (0.95%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  7/105 (6.67%)  8
Alanine aminotransferase increased  1  28/105 (26.67%)  36
Alkaline phosphatase  1  17/105 (16.19%)  21
Alkaline phosphatase increased  1  3/105 (2.86%)  3
Amylase increased  1  1/105 (0.95%)  1
Aspartate aminotransferase increased  1  25/105 (23.81%)  32
Blood bilirubin increased  1  22/105 (20.95%)  23
Cardiac troponin I increased  1  2/105 (1.90%)  2
Coagulopathy  1  2/105 (1.90%)  2
Creatinine increased  1  26/105 (24.76%)  29
INR increased  1  2/105 (1.90%)  2
Laboratory test abnormal  1  7/105 (6.67%)  8
Leukocyte count decreased  1  19/105 (18.10%)  26
Lipase increased  1  1/105 (0.95%)  1
Lymphocyte count decreased  1  13/105 (12.38%)  16
Neutrophil count decreased  1  55/105 (52.38%)  72
Platelet count decreased  1  56/105 (53.33%)  75
Weight gain  1  2/105 (1.90%)  2
Weight loss  1  7/105 (6.67%)  7
Metabolism and nutrition disorders   
Acidosis  1  4/105 (3.81%)  4
Alkalosis  1  1/105 (0.95%)  1
Anorexia  1  16/105 (15.24%)  18
Blood glucose increased  1  47/105 (44.76%)  63
Blood uric acid increased  1  4/105 (3.81%)  4
Dehydration  1  4/105 (3.81%)  6
Serum albumin decreased  1  23/105 (21.90%)  31
Serum calcium decreased  1  32/105 (30.48%)  40
Serum calcium increased  1  2/105 (1.90%)  2
Serum glucose decreased  1  5/105 (4.76%)  6
Serum magnesium decreased  1  20/105 (19.05%)  25
Serum magnesium increased  1  5/105 (4.76%)  5
Serum phosphate decreased  1  12/105 (11.43%)  12
Serum potassium decreased  1  40/105 (38.10%)  49
Serum potassium increased  1  3/105 (2.86%)  3
Serum sodium decreased  1  15/105 (14.29%)  20
Serum sodium increased  1  7/105 (6.67%)  7
Tumor lysis syndrome  1  3/105 (2.86%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/105 (2.86%)  3
Back pain  1  4/105 (3.81%)  4
Bone pain  1  5/105 (4.76%)  5
Chest wall pain  1  1/105 (0.95%)  1
Muscle weakness  1  1/105 (0.95%)  1
Myalgia  1  4/105 (3.81%)  5
Osteonecrosis  1  1/105 (0.95%)  1
Pain in extremity  1  1/105 (0.95%)  1
Nervous system disorders   
Ataxia  1  1/105 (0.95%)  1
Depressed level of consciousness  1  4/105 (3.81%)  4
Dizziness  1  7/105 (6.67%)  7
Encephalopathy  1  1/105 (0.95%)  1
Extrapyramidal disorder  1  1/105 (0.95%)  1
Headache  1  19/105 (18.10%)  22
Intracranial hemorrhage  1  1/105 (0.95%)  1
Ischemia cerebrovascular  1  1/105 (0.95%)  1
Neuralgia  1  1/105 (0.95%)  1
Neurological disorder NOS  1  1/105 (0.95%)  1
Peripheral motor neuropathy  1  6/105 (5.71%)  7
Peripheral sensory neuropathy  1  13/105 (12.38%)  13
Seizure  1  3/105 (2.86%)  3
Speech disorder  1  2/105 (1.90%)  2
Syncope  1  1/105 (0.95%)  1
Tremor  1  3/105 (2.86%)  3
Psychiatric disorders   
Agitation  1  1/105 (0.95%)  1
Anxiety  1  7/105 (6.67%)  8
Confusion  1  8/105 (7.62%)  8
Depression  1  9/105 (8.57%)  9
Insomnia  1  3/105 (2.86%)  3
Personality change  1  1/105 (0.95%)  1
Psychosis  1  1/105 (0.95%)  1
Renal and urinary disorders   
Bladder pain  1  1/105 (0.95%)  1
Dysuria (painful urination)  1  2/105 (1.90%)  2
Hematuria (in the absence of vaginal bleeding)  1  3/105 (2.86%)  4
Proteinuria  1  1/105 (0.95%)  1
Renal failure  1  7/105 (6.67%)  7
Urethral fistula  1  1/105 (0.95%)  1
Urinary frequency  1  1/105 (0.95%)  1
Urinary incontinence  1  1/105 (0.95%)  1
Urinary retention  1  1/105 (0.95%)  1
Urogenital disorder  1  5/105 (4.76%)  5
Reproductive system and breast disorders   
Pelvic pain  1  1/105 (0.95%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  5/105 (4.76%)  5
Allergic rhinitis  1  4/105 (3.81%)  5
Atelectasis  1  2/105 (1.90%)  2
Bronchospasm  1  1/105 (0.95%)  1
Cough  1  10/105 (9.52%)  10
Dyspnea  1  1/105 (0.95%)  1
Dyspnea (shortness of breath)  1  14/105 (13.33%)  15
Epistaxis  1  4/105 (3.81%)  6
Hemoptysis  1  1/105 (0.95%)  1
Hiccups  1  3/105 (2.86%)  3
Hypoxia  1  9/105 (8.57%)  9
Pharyngolaryngeal pain  1  2/105 (1.90%)  2
Pleural effusion  1  8/105 (7.62%)  9
Pleuritic pain  1  1/105 (0.95%)  1
Pneumonitis  1  3/105 (2.86%)  3
Pneumothorax  1  2/105 (1.90%)  2
Respiratory disorder  1  7/105 (6.67%)  7
Tracheal stenosis  1  1/105 (0.95%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  4/105 (3.81%)  6
Decubitus ulcer  1  1/105 (0.95%)  1
Dry skin  1  2/105 (1.90%)  2
Erythema multiforme  1  3/105 (2.86%)  3
Hand-and-foot syndrome  1  1/105 (0.95%)  1
Nail disorder  1  1/105 (0.95%)  1
Pain of skin  1  1/105 (0.95%)  1
Petechiae  1  1/105 (0.95%)  1
Pruritus  1  3/105 (2.86%)  3
Rash desquamating  1  14/105 (13.33%)  15
Skin disorder  1  3/105 (2.86%)  3
Skin ulceration  1  1/105 (0.95%)  1
Sweating  1  8/105 (7.62%)  8
Vascular disorders   
Flushing  1  1/105 (0.95%)  1
Hemorrhage  1  2/105 (1.90%)  2
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  3/105 (2.86%)  3
Hypertension  1  10/105 (9.52%)  10
Hypotension  1  14/105 (13.33%)  17
Phlebitis  1  1/105 (0.95%)  1
Thrombosis  1  4/105 (3.81%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab With High Intensity Chemotherapy
Affected / at Risk (%) # Events
Total   101/105 (96.19%)    
Blood and lymphatic system disorders   
Blood disorder  1  2/105 (1.90%)  2
Febrile neutropenia  1  65/105 (61.90%)  130
Hemoglobin decreased  1  100/105 (95.24%)  642
Lymphatic disorder  1  1/105 (0.95%)  1
Transfusion: Platelets  1  18/105 (17.14%)  41
Transfusion: pRBCs  1  18/105 (17.14%)  72
Cardiac disorders   
Arrhythmia  1  4/105 (3.81%)  4
Arrhythmia supraventricular  1  4/105 (3.81%)  5
Atrial fibrillation  1  2/105 (1.90%)  2
Cardiac disorder  1  10/105 (9.52%)  10
Edema  1  38/105 (36.19%)  80
Left ventricular failure  1  3/105 (2.86%)  5
Myocardial ischemia  1  1/105 (0.95%)  1
Pericardial effusion  1  2/105 (1.90%)  2
Sinus bradycardia  1  11/105 (10.48%)  12
Sinus tachycardia  1  22/105 (20.95%)  35
Ear and labyrinth disorders   
Ear disorder  1  4/105 (3.81%)  4
Ear pain  1  3/105 (2.86%)  3
Tinnitus  1  1/105 (0.95%)  1
Vertigo  1  1/105 (0.95%)  1
Endocrine disorders   
Endocrine disorder  1  2/105 (1.90%)  2
Eye disorders   
Conjunctivitis  1  4/105 (3.81%)  4
Diplopia  1  2/105 (1.90%)  3
Dry eye syndrome  1  5/105 (4.76%)  6
Eye disorder  1  9/105 (8.57%)  12
Flashing vision  1  3/105 (2.86%)  3
Photophobia  1  2/105 (1.90%)  2
Vision blurred  1  10/105 (9.52%)  15
Watering eyes  1  5/105 (4.76%)  6
Gastrointestinal disorders   
Abdominal distension  1  5/105 (4.76%)  5
Abdominal pain  1  43/105 (40.95%)  78
Anal fistula  1  3/105 (2.86%)  4
Anal pain  1  2/105 (1.90%)  2
Ascites  1  1/105 (0.95%)  1
Constipation  1  53/105 (50.48%)  111
Diarrhea  1  63/105 (60.00%)  127
Dry mouth  1  12/105 (11.43%)  14
Dyspepsia  1  24/105 (22.86%)  39
Ear, nose and throat examination abnormal  1  6/105 (5.71%)  6
Esophageal pain  1  2/105 (1.90%)  3
Esophagitis  1  59/105 (56.19%)  121
Fecal incontinence  1  1/105 (0.95%)  1
Flatulence  1  2/105 (1.90%)  3
Gastritis  1  1/105 (0.95%)  1
Gastrointestinal disorder  1  12/105 (11.43%)  14
Hemorrhoids  1  2/105 (1.90%)  4
Ileus  1  2/105 (1.90%)  2
Melena/GI bleeding  1  5/105 (4.76%)  6
Mucositis oral  1  91/105 (86.67%)  325
Nausea  1  89/105 (84.76%)  294
Oral pain  1  6/105 (5.71%)  8
Proctitis  1  2/105 (1.90%)  2
Rectal bleeding/hematochezia  1  5/105 (4.76%)  5
Rectal hemorrhage  1  2/105 (1.90%)  2
Rectal pain  1  10/105 (9.52%)  16
Vomiting  1  53/105 (50.48%)  121
General disorders   
Chest pain  1  7/105 (6.67%)  8
Chills  1  21/105 (20.00%)  28
Edema limbs  1  8/105 (7.62%)  12
Fatigue  1  79/105 (75.24%)  279
Fever  1  26/105 (24.76%)  39
General symptom  1  8/105 (7.62%)  9
Ill-defined disorder  1  2/105 (1.90%)  2
Injection site reaction  1  1/105 (0.95%)  1
Localized edema  1  2/105 (1.90%)  2
Pain  1  49/105 (46.67%)  113
Hepatobiliary disorders   
Cholecystitis  1  1/105 (0.95%)  1
Hepatobiliary disease  1  4/105 (3.81%)  7
Immune system disorders   
Hypersensitivity  1  6/105 (5.71%)  8
Immune system disorder  1  2/105 (1.90%)  4
Infections and infestations   
Abdominal infection  1  1/105 (0.95%)  1
Anorectal infection  1  1/105 (0.95%)  1
Catheter related infection  1  6/105 (5.71%)  9
Infection  1  8/105 (7.62%)  12
Infection with grade 3 or 4 neutropenia  1  65/105 (61.90%)  144
Infection with unknown ANC  1  1/105 (0.95%)  1
Infection without neutropenia  1  51/105 (48.57%)  101
Mucosal infection  1  1/105 (0.95%)  1
Opportunistic infection  1  1/105 (0.95%)  2
Sepsis  1  1/105 (0.95%)  1
Skin infection  1  1/105 (0.95%)  1
Upper respiratory infection  1  2/105 (1.90%)  2
Urinary tract infection  1  2/105 (1.90%)  2
Wound-infectious  1  3/105 (2.86%)  3
Injury, poisoning and procedural complications   
Bruising  1  5/105 (4.76%)  5
Operative injury to bladder and/or ureter  1  1/105 (0.95%)  1
Wound dehiscence  1  1/105 (0.95%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  12/105 (11.43%)  17
Alanine aminotransferase increased  1  71/105 (67.62%)  236
Alkaline phosphatase  1  46/105 (43.81%)  92
Alkaline phosphatase increased  1  16/105 (15.24%)  29
Amylase increased  1  2/105 (1.90%)  2
Aspartate aminotransferase increased  1  66/105 (62.86%)  175
Blood bilirubin increased  1  41/105 (39.05%)  89
Coagulopathy  1  4/105 (3.81%)  4
Creatine phosphokinase increased  1  1/105 (0.95%)  1
Creatinine increased  1  46/105 (43.81%)  139
Electrocardiogram QTc interval prolonged  1  1/105 (0.95%)  1
Fibrinogen decreased  1  4/105 (3.81%)  5
Gamma-glutamyltransferase increased  1  3/105 (2.86%)  6
INR increased  1  11/105 (10.48%)  20
Laboratory test abnormal  1  17/105 (16.19%)  34
Leukocyte count decreased  1  45/105 (42.86%)  169
Lymphocyte count decreased  1  36/105 (34.29%)  137
Neutrophil count decreased  1  98/105 (93.33%)  493
Platelet count decreased  1  98/105 (93.33%)  596
Serum cholesterol increased  1  2/105 (1.90%)  4
Weight gain  1  5/105 (4.76%)  5
Weight loss  1  21/105 (20.00%)  22
Metabolism and nutrition disorders   
Anorexia  1  48/105 (45.71%)  103
Blood bicarbonate decreased  1  1/105 (0.95%)  1
Blood glucose increased  1  92/105 (87.62%)  452
Blood uric acid increased  1  8/105 (7.62%)  10
Dehydration  1  8/105 (7.62%)  10
Iron overload  1  1/105 (0.95%)  3
Serum albumin decreased  1  56/105 (53.33%)  167
Serum calcium decreased  1  69/105 (65.71%)  236
Serum calcium increased  1  6/105 (5.71%)  15
Serum glucose decreased  1  16/105 (15.24%)  31
Serum magnesium decreased  1  43/105 (40.95%)  80
Serum magnesium increased  1  24/105 (22.86%)  29
Serum phosphate decreased  1  40/105 (38.10%)  102
Serum potassium decreased  1  77/105 (73.33%)  270
Serum potassium increased  1  16/105 (15.24%)  20
Serum sodium decreased  1  43/105 (40.95%)  132
Serum sodium increased  1  13/105 (12.38%)  20
Serum triglycerides increased  1  3/105 (2.86%)  5
Tumor lysis syndrome  1  7/105 (6.67%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  11/105 (10.48%)  17
Arthritis  1  2/105 (1.90%)  2
Back pain  1  13/105 (12.38%)  29
Bone pain  1  17/105 (16.19%)  28
Buttock pain  1  2/105 (1.90%)  3
Chest wall pain  1  1/105 (0.95%)  1
Muscle weakness  1  5/105 (4.76%)  5
Muscle weakness lower limb  1  1/105 (0.95%)  1
Musculoskeletal disorder  1  5/105 (4.76%)  7
Myalgia  1  22/105 (20.95%)  44
Neck pain  1  3/105 (2.86%)  4
Osteoporosis  1  1/105 (0.95%)  1
Pain in extremity  1  7/105 (6.67%)  10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment related secondary malignancy  1  1/105 (0.95%)  1
Tumor pain (onset or exacerbation of tumor pain due to treatment)  1  1/105 (0.95%)  1
Nervous system disorders   
Arachnoiditis  1  1/105 (0.95%)  1
Ataxia  1  5/105 (4.76%)  7
Depressed level of consciousness  1  2/105 (1.90%)  2
Dizziness  1  24/105 (22.86%)  39
Dysgeusia  1  8/105 (7.62%)  9
Extrapyramidal disorder  1  1/105 (0.95%)  1
Headache  1  56/105 (53.33%)  113
Intracranial hemorrhage  1  2/105 (1.90%)  3
Memory impairment  1  2/105 (1.90%)  3
Neuralgia  1  6/105 (5.71%)  14
Neurological disorder NOS  1  8/105 (7.62%)  9
Neuropathy - cranial  1  1/105 (0.95%)  1
Peripheral motor neuropathy  1  23/105 (21.90%)  57
Peripheral sensory neuropathy  1  50/105 (47.62%)  206
Pyramidal tract syndrome  1  1/105 (0.95%)  1
Sense of smell  1  1/105 (0.95%)  1
Syncope  1  3/105 (2.86%)  3
Tremor  1  6/105 (5.71%)  10
Psychiatric disorders   
Anxiety  1  21/105 (20.00%)  43
Confusion  1  12/105 (11.43%)  13
Depression  1  29/105 (27.62%)  56
Insomnia  1  30/105 (28.57%)  50
Libido decreased  1  2/105 (1.90%)  2
Personality change  1  2/105 (1.90%)  3
Psychosis  1  1/105 (0.95%)  1
Renal and urinary disorders   
Bladder hemorrhage  1  1/105 (0.95%)  1
Bladder pain  1  1/105 (0.95%)  1
Bladder spasm  1  4/105 (3.81%)  7
Dysuria (painful urination)  1  7/105 (6.67%)  8
Hematuria (in the absence of vaginal bleeding)  1  6/105 (5.71%)  7
Incontinence  1  4/105 (3.81%)  4
Proteinuria  1  1/105 (0.95%)  1
Renal failure  1  6/105 (5.71%)  8
Ureteric obstruction  1  1/105 (0.95%)  1
Urethral pain  1  1/105 (0.95%)  1
Urinary frequency  1  7/105 (6.67%)  12
Urinary incontinence  1  1/105 (0.95%)  2
Urinary retention  1  4/105 (3.81%)  4
Urogenital disorder  1  9/105 (8.57%)  12
Reproductive system and breast disorders   
Erectile dysfunction  1  4/105 (3.81%)  4
Gynecomastia  1  2/105 (1.90%)  4
Irregular menstruation  1  1/105 (0.95%)  2
Pelvic pain  1  5/105 (4.76%)  5
Reproductive tract disorder  1  1/105 (0.95%)  1
Vaginal dryness  1  2/105 (1.90%)  6
Vaginal hemorrhage  1  2/105 (1.90%)  6
Vaginal inflammation  1  1/105 (0.95%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  15/105 (14.29%)  33
Bronchospasm  1  3/105 (2.86%)  4
Cough  1  35/105 (33.33%)  75
Dyspnea  1  4/105 (3.81%)  4
Dyspnea (shortness of breath)  1  22/105 (20.95%)  26
Epistaxis  1  26/105 (24.76%)  34
Hemoptysis  1  1/105 (0.95%)  1
Hiccups  1  9/105 (8.57%)  13
Hypoxia  1  6/105 (5.71%)  7
Laryngeal edema  1  1/105 (0.95%)  1
Laryngoscopy abnormal  1  1/105 (0.95%)  1
Pharyngolaryngeal pain  1  7/105 (6.67%)  7
Pleural effusion  1  10/105 (9.52%)  14
Pleuritic pain  1  2/105 (1.90%)  2
Pneumonitis  1  3/105 (2.86%)  5
Respiratory disorder  1  17/105 (16.19%)  23
Respiratory tract hemorrhage  1  1/105 (0.95%)  1
Voice alteration  1  4/105 (3.81%)  5
Skin and subcutaneous tissue disorders   
Alopecia  1  29/105 (27.62%)  56
Decubitus ulcer  1  3/105 (2.86%)  6
Dry skin  1  8/105 (7.62%)  9
Erythema multiforme  1  2/105 (1.90%)  2
Hand-and-foot syndrome  1  1/105 (0.95%)  1
Nail disorder  1  1/105 (0.95%)  1
Pain of skin  1  2/105 (1.90%)  2
Petechiae  1  13/105 (12.38%)  21
Pigmentation changes (e.g., vitiligo)  1  2/105 (1.90%)  2
Pruritus  1  16/105 (15.24%)  23
Rash acneiform  1  1/105 (0.95%)  1
Rash desquamating  1  49/105 (46.67%)  78
Skin disorder  1  10/105 (9.52%)  12
Skin induration  1  1/105 (0.95%)  1
Skin ulceration  1  2/105 (1.90%)  2
Sweating  1  32/105 (30.48%)  52
Urticaria  1  1/105 (0.95%)  1
Vascular disorders   
Flushing  1  4/105 (3.81%)  6
Hemorrhage  1  8/105 (7.62%)  8
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  4/105 (3.81%)  4
Hot flashes  1  3/105 (2.86%)  4
Hypertension  1  27/105 (25.71%)  53
Hypotension  1  23/105 (21.90%)  35
Lymphedema  1  1/105 (0.95%)  1
Phlebitis  1  1/105 (0.95%)  2
Thrombosis  1  6/105 (5.71%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5
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.
Must obtain prior Sponsor approval
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Rizzieri, M.D.
Organization: Duke University Medical Center
EMail: rizzi003@dm.duke.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00039130    
Other Study ID Numbers: CALGB-10002
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-10002
CDR0000069354 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 6, 2002
First Posted: January 27, 2003
Results First Submitted: October 16, 2014
Results First Posted: October 22, 2014
Last Update Posted: August 1, 2016