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Trial record 6 of 73 for:    Peru | Panama

A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00486759
Recruitment Status : Terminated (Due to an unfavorable benefit/risk ratio.)
First Posted : June 15, 2007
Results First Posted : December 31, 2012
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition B-cell Lymphoma
Interventions Drug: Bevacizumab
Drug: Rituximab
Drug: CHOP
Drug: Placebo
Enrollment 787
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Hide Arm/Group Description Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone). Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Period Title: Treatment
Started 390 397
Completed 203 260
Not Completed 187 137
Reason Not Completed
Adverse event/intercurrent illness             86             39
Insufficient therapeutic response             37             39
Death             17             10
Withdrew consent             15             12
Administrative/reason not specified             17             21
Refused treatment             10             7
Violation of selection criteria at entry             3             3
Other protocol violation             1             5
Failure to return             1             1
Period Title: Safety Follow-up
Started 203 260
Completed 64 142
Not Completed 139 118
Reason Not Completed
Insufficient therapeutic response             40             50
Death             40             29
Withdrew consent             32             23
Failure to return             9             6
Administrative/not specified             8             6
Refused treatment/did not cooperate             6             4
Adverse event/intercurrent illness             4             0
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP Total
Hide Arm/Group Description Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone). Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone). Total of all reporting groups
Overall Number of Baseline Participants 390 397 787
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 390 participants 397 participants 787 participants
57.89  (14.256) 56.98  (15.399) 57.44  (14.841)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 390 participants 397 participants 787 participants
Female
207
  53.1%
193
  48.6%
400
  50.8%
Male
183
  46.9%
204
  51.4%
387
  49.2%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.
Time Frame Baseline to end of the study (up to 4 years, 4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Hide Arm/Group Description:
Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Overall Number of Participants Analyzed 390 397
Median (Inter-Quartile Range)
Unit of Measure: Months
40.2 [1] 
(12.1 to NA)
42.9 [1] 
(13.6 to NA)
[1]
The 75th percentile could not be estimated due to a lack of events.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame Baseline to end of the study (up to 4 years, 4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Hide Arm/Group Description:
Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Overall Number of Participants Analyzed 390 397
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(34.0 to NA)
NA [1] 
(42.9 to NA)
[1]
The median and 75th percentile could not be estimated due to a lack of events,
3.Secondary Outcome
Title Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma
Hide Description OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.
Time Frame At the end of treatment (Cycle 8, up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Hide Arm/Group Description:
Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Overall Number of Participants Analyzed 390 397
Measure Type: Number
Unit of Measure: Percentage of patients
63.1 70.5
Time Frame All adverse events (AE) were reported starting from the first dose up to 92 days after the last dose of study drug. AEs of special interest were reported up to 6 months after the last dose.
Adverse Event Reporting Description Safety analysis population: All patients who received at least 1 dose of study drug whether withdrawn prematurely or not. Bevacizumab (B) 395=390 randomized-2 no treatment+7 randomized to placebo who received B. Placebo to B 386=397 randomized-5 no treatment-7 received B+1 randomized to B who received placebo but no B.
 
Arm/Group Title Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Hide Arm/Group Description Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone). Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
All-Cause Mortality
Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Affected / at Risk (%) Affected / at Risk (%)
Total   224/395 (56.71%)   173/386 (44.82%) 
Blood and lymphatic system disorders     
Febrile neutorpenia  1  63/395 (15.95%)  48/386 (12.44%) 
Neutropenia  1  12/395 (3.04%)  17/386 (4.40%) 
Leukopenia  1  6/395 (1.52%)  5/386 (1.30%) 
Anaemia  1  8/395 (2.03%)  1/386 (0.26%) 
Thrombocytopenia  1  5/395 (1.27%)  4/386 (1.04%) 
Agranulocytosis  1  3/395 (0.76%)  2/386 (0.52%) 
Febrile bone marrow aplasia  1  0/395 (0.00%)  3/386 (0.78%) 
Pancytopenia  1  2/395 (0.51%)  1/386 (0.26%) 
Lymphopenia  1  2/395 (0.51%)  0/386 (0.00%) 
Splenic vein thrombosis  1  1/395 (0.25%)  0/386 (0.00%) 
Splenomegaly  1  1/395 (0.25%)  0/386 (0.00%) 
Cardiac disorders     
Left ventricular dysfunction  1  15/395 (3.80%)  5/386 (1.30%) 
Cardiac failure  1  6/395 (1.52%)  4/386 (1.04%) 
Cardiac failure congestive  1  5/395 (1.27%)  2/386 (0.52%) 
Atrial fibrillation  1  2/395 (0.51%)  4/386 (1.04%) 
Angina pectoris  1  1/395 (0.25%)  1/386 (0.26%) 
Cardiovascular disorder  1  1/395 (0.25%)  1/386 (0.26%) 
Restrictive cardiomyopathy  1  1/395 (0.25%)  1/386 (0.26%) 
Angina unstable  1  0/395 (0.00%)  1/386 (0.26%) 
Arrhythmia  1  1/395 (0.25%)  0/386 (0.00%) 
Atrioventricular block complete  1  1/395 (0.25%)  0/386 (0.00%) 
Cardiac disorder  1  1/395 (0.25%)  0/386 (0.00%) 
Cardiomyopathy  1  1/395 (0.25%)  0/386 (0.00%) 
Cardiotoxicity  1  0/395 (0.00%)  1/386 (0.26%) 
Congestive cardiomyopathy  1  1/395 (0.25%)  0/386 (0.00%) 
Sick sinus syndrome  1  1/395 (0.25%)  0/386 (0.00%) 
Sinus tachycardia  1  0/395 (0.00%)  1/386 (0.26%) 
Supraventricular tachycardia  1  1/395 (0.25%)  0/386 (0.00%) 
Tachyarrhythmia  1  0/395 (0.00%)  1/386 (0.26%) 
Ventricular hypokinesia  1  1/395 (0.25%)  0/386 (0.00%) 
Congenital, familial and genetic disorders     
Aplasia  1  1/395 (0.25%)  0/386 (0.00%) 
Endocrine disorders     
Hyperthyroidism  1  0/395 (0.00%)  1/386 (0.26%) 
Toxic nodular goitre  1  1/395 (0.25%)  0/386 (0.00%) 
Eye disorders     
Retinal detachment  1  0/395 (0.00%)  1/386 (0.26%) 
Retinal haemorrhage  1  0/395 (0.00%)  1/386 (0.26%) 
Retinal vein thrombosis  1  0/395 (0.00%)  1/386 (0.26%) 
Gastrointestinal disorders     
Abdominal pain  1  4/395 (1.01%)  5/386 (1.30%) 
Diarrhoea  1  6/395 (1.52%)  3/386 (0.78%) 
Ascites  1  4/395 (1.01%)  0/386 (0.00%) 
Constipation  1  2/395 (0.51%)  2/386 (0.52%) 
Gastric perforation  1  3/395 (0.76%)  0/386 (0.00%) 
Nausea  1  3/395 (0.76%)  0/386 (0.00%) 
Stomatitis  1  2/395 (0.51%)  1/386 (0.26%) 
Abdominal pain upper  1  1/395 (0.25%)  1/386 (0.26%) 
Gastrointestinal haemorrhage  1  1/395 (0.25%)  1/386 (0.26%) 
Upper gastrointestinal haemorrhage  1  2/395 (0.51%)  0/386 (0.00%) 
Abdominal pain lower  1  1/395 (0.25%)  0/386 (0.00%) 
Anal fissure  1  1/395 (0.25%)  0/386 (0.00%) 
Enteritis  1  0/395 (0.00%)  1/386 (0.26%) 
Gastrointestinal hypomotility  1  0/395 (0.00%)  1/386 (0.26%) 
Haemorrhoidal haemorrhage  1  1/395 (0.25%)  0/386 (0.00%) 
Haemorrhoids  1  1/395 (0.25%)  0/386 (0.00%) 
Ileal perforation  1  1/395 (0.25%)  0/386 (0.00%) 
Ileus paralytic  1  1/395 (0.25%)  0/386 (0.00%) 
Impaired gastric emptying  1  0/395 (0.00%)  1/386 (0.26%) 
Inguinal hernia  1  1/395 (0.25%)  0/386 (0.00%) 
Inguinal hernia, obstructive  1  0/395 (0.00%)  1/386 (0.26%) 
Intestinal perforation  1  1/395 (0.25%)  0/386 (0.00%) 
Melaena  1  0/395 (0.00%)  1/386 (0.26%) 
Periodontitis  1  1/395 (0.25%)  0/386 (0.00%) 
Rectal ulcer  1  0/395 (0.00%)  1/386 (0.26%) 
Small intestinal obstruction  1  0/395 (0.00%)  1/386 (0.26%) 
Small intestinal perforation  1  1/395 (0.25%)  0/386 (0.00%) 
Subileus  1  1/395 (0.25%)  0/386 (0.00%) 
Volvulus  1  1/395 (0.25%)  0/386 (0.00%) 
Vomiting  1  1/395 (0.25%)  0/386 (0.00%) 
General disorders     
Pyrexia  1  14/395 (3.54%)  15/386 (3.89%) 
Asthenia  1  4/395 (1.01%)  2/386 (0.52%) 
Chest pain  1  0/395 (0.00%)  3/386 (0.78%) 
Death  1  1/395 (0.25%)  2/386 (0.52%) 
General physical health deterioration  1  3/395 (0.76%)  0/386 (0.00%) 
Fatigue  1  1/395 (0.25%)  1/386 (0.26%) 
Mucosal inflammation  1  2/395 (0.51%)  0/386 (0.00%) 
Catheter site haemorrhage  1  1/395 (0.25%)  0/386 (0.00%) 
Effusion  1  1/395 (0.25%)  0/386 (0.00%) 
Hyperthermia  1  1/395 (0.25%)  0/386 (0.00%) 
Impaired healing  1  1/395 (0.25%)  0/386 (0.00%) 
Influenza like illness  1  0/395 (0.00%)  1/386 (0.26%) 
Local swelling  1  0/395 (0.00%)  1/386 (0.26%) 
Medical device complication  1  1/395 (0.25%)  0/386 (0.00%) 
Multi-organ failure  1  1/395 (0.25%)  0/386 (0.00%) 
Oedema peripheral  1  0/395 (0.00%)  1/386 (0.26%) 
Pain  1  0/395 (0.00%)  1/386 (0.26%) 
Hepatobiliary disorders     
Acute hepatic failure  1  1/395 (0.25%)  0/386 (0.00%) 
Bile duct stone  1  1/395 (0.25%)  0/386 (0.00%) 
Cholangitis  1  1/395 (0.25%)  0/386 (0.00%) 
Cholecystitis acute  1  1/395 (0.25%)  0/386 (0.00%) 
Hepatitis  1  1/395 (0.25%)  0/386 (0.00%) 
Jaundice cholestatic  1  1/395 (0.25%)  0/386 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/395 (0.25%)  2/386 (0.52%) 
Anaphylactic reaction  1  1/395 (0.25%)  0/386 (0.00%) 
Infections and infestations     
Pneumonia  1  22/395 (5.57%)  16/386 (4.15%) 
Septic shock  1  6/395 (1.52%)  4/386 (1.04%) 
Infection  1  3/395 (0.76%)  6/386 (1.55%) 
Urinary tract infection  1  6/395 (1.52%)  3/386 (0.78%) 
Bronchopneumonia  1  2/395 (0.51%)  6/386 (1.55%) 
Gastroenteritis  1  2/395 (0.51%)  4/386 (1.04%) 
Neutropenic sepsis  1  5/395 (1.27%)  1/386 (0.26%) 
Sepsis  1  2/395 (0.51%)  4/386 (1.04%) 
Neutropenic infection  1  1/395 (0.25%)  4/386 (1.04%) 
Device related infection  1  2/395 (0.51%)  1/386 (0.26%) 
Lower respiratory tract infection  1  1/395 (0.25%)  2/386 (0.52%) 
Anal abscess  1  2/395 (0.51%)  0/386 (0.00%) 
Appendicitis  1  1/395 (0.25%)  1/386 (0.26%) 
Bronchitis  1  1/395 (0.25%)  1/386 (0.26%) 
Cellulitis  1  0/395 (0.00%)  2/386 (0.52%) 
Cystitis  1  1/395 (0.25%)  1/386 (0.26%) 
Erysipelas  1  0/395 (0.00%)  2/386 (0.52%) 
Escherichia sepsis  1  0/395 (0.00%)  2/386 (0.52%) 
Herpes zoster  1  1/395 (0.25%)  1/386 (0.26%) 
Oesophageal candidiasis  1  2/395 (0.51%)  0/386 (0.00%) 
Pharyngitis  1  1/395 (0.25%)  1/386 (0.26%) 
Pneumocystis jiroveci pneumonia  1  0/395 (0.00%)  2/386 (0.52%) 
Respiratory tract infection  1  2/395 (0.51%)  0/386 (0.00%) 
Abdominal abscess  1  1/395 (0.25%)  0/386 (0.00%) 
Acute tonsillitis  1  1/395 (0.25%)  0/386 (0.00%) 
Amoebiasis  1  1/395 (0.25%)  0/386 (0.00%) 
Appendiceal abscess  1  0/395 (0.00%)  1/386 (0.26%) 
Bronchitis bacterial  1  1/395 (0.25%)  0/386 (0.00%) 
Bronchopulmonary aspergillosis  1  0/395 (0.00%)  1/386 (0.26%) 
Enterococcal infection  1  0/395 (0.00%)  1/386 (0.26%) 
Fungal oesophagitis  1  0/395 (0.00%)  1/386 (0.26%) 
Gastroenteritis norovirus  1  0/395 (0.00%)  1/386 (0.26%) 
Gastrointestinal fungal infection  1  0/395 (0.00%)  1/386 (0.26%) 
Gastrointestinal infection  1  1/395 (0.25%)  0/386 (0.00%) 
H1N1 influenza  1  0/395 (0.00%)  1/386 (0.26%) 
Infectious peritonitis  1  1/395 (0.25%)  0/386 (0.00%) 
Influenza  1  0/395 (0.00%)  1/386 (0.26%) 
Localised infection  1  1/395 (0.25%)  0/386 (0.00%) 
Lung infection  1  1/395 (0.25%)  0/386 (0.00%) 
Lymph gland infection  1  1/395 (0.25%)  0/386 (0.00%) 
Lymphadenitis bacterial  1  0/395 (0.00%)  1/386 (0.26%) 
Meningitis cryptococcal  1  0/395 (0.00%)  1/386 (0.26%) 
Mucosal infection  1  0/395 (0.00%)  1/386 (0.26%) 
Oral candidiasis  1  1/395 (0.25%)  0/386 (0.00%) 
Oral infection  1  0/395 (0.00%)  1/386 (0.26%) 
Orchitis  1  0/395 (0.00%)  1/386 (0.26%) 
Otitis media  1  0/395 (0.00%)  1/386 (0.26%) 
Paronychia  1  0/395 (0.00%)  1/386 (0.26%) 
Perirectal abscess  1  1/395 (0.25%)  0/386 (0.00%) 
Pneumocystis jiroveci infection  1  0/395 (0.00%)  1/386 (0.26%) 
Pneumonia viral  1  1/395 (0.25%)  0/386 (0.00%) 
Pulmonary sepsis  1  1/395 (0.25%)  0/386 (0.00%) 
Pyelonephritis  1  0/395 (0.00%)  1/386 (0.26%) 
Pyelonephritis acute  1  1/395 (0.25%)  0/386 (0.00%) 
Respiratory syncytial virus infection  1  0/395 (0.00%)  1/386 (0.26%) 
Sinusitis  1  0/395 (0.00%)  1/386 (0.26%) 
Splenic abscess  1  1/395 (0.25%)  0/386 (0.00%) 
Staphylococcal infection  1  0/395 (0.00%)  1/386 (0.26%) 
Systemic candida  1  1/395 (0.25%)  0/386 (0.00%) 
Tooth abscess  1  1/395 (0.25%)  0/386 (0.00%) 
Tuberculous pleurisy  1  0/395 (0.00%)  1/386 (0.26%) 
Upper respiratory tract infection  1  0/395 (0.00%)  1/386 (0.26%) 
Urosepsis  1  0/395 (0.00%)  1/386 (0.26%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/395 (0.25%)  0/386 (0.00%) 
Chemical injury  1  1/395 (0.25%)  0/386 (0.00%) 
Fall  1  0/395 (0.00%)  1/386 (0.26%) 
Femoral neck fracture  1  1/395 (0.25%)  0/386 (0.00%) 
Head injury  1  0/395 (0.00%)  1/386 (0.26%) 
Injury  1  1/395 (0.25%)  0/386 (0.00%) 
Laceration  1  0/395 (0.00%)  1/386 (0.26%) 
Lower limb fracture  1  1/395 (0.25%)  0/386 (0.00%) 
Lumbar vertebral fracture  1  0/395 (0.00%)  1/386 (0.26%) 
Post lumbar puncture syndrome  1  1/395 (0.25%)  0/386 (0.00%) 
Road traffic accident  1  1/395 (0.25%)  0/386 (0.00%) 
Spinal compression fracture  1  1/395 (0.25%)  0/386 (0.00%) 
Subdural haematoma  1  0/395 (0.00%)  1/386 (0.26%) 
Traumatic lung injury  1  1/395 (0.25%)  0/386 (0.00%) 
Ulna fracture  1  1/395 (0.25%)  0/386 (0.00%) 
Investigations     
Ejection fraction decreased  1  4/395 (1.01%)  3/386 (0.78%) 
C-reactive protein increased  1  1/395 (0.25%)  1/386 (0.26%) 
Alanine aminotransferase increased  1  1/395 (0.25%)  0/386 (0.00%) 
Aspartate aminotransferase increased  1  1/395 (0.25%)  0/386 (0.00%) 
General physical condition abnormal  1  1/395 (0.25%)  0/386 (0.00%) 
Hepatic enzyme increased  1  1/395 (0.25%)  0/386 (0.00%) 
Multiple gated acquisition scan abnormal  1  1/395 (0.25%)  0/386 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/395 (0.51%)  4/386 (1.04%) 
Hyperglycaemia  1  3/395 (0.76%)  1/386 (0.26%) 
Hypokalaemia  1  1/395 (0.25%)  3/386 (0.78%) 
Diabetes mellitus inadequate control  1  0/395 (0.00%)  1/386 (0.26%) 
Hypoglycaemia  1  1/395 (0.25%)  0/386 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/395 (0.25%)  1/386 (0.26%) 
Arthralgia  1  0/395 (0.00%)  1/386 (0.26%) 
Bone pain  1  1/395 (0.25%)  0/386 (0.00%) 
Muscle atrophy  1  1/395 (0.25%)  0/386 (0.00%) 
Myofascial pain syndrome  1  1/395 (0.25%)  0/386 (0.00%) 
Osteoporosis  1  0/395 (0.00%)  1/386 (0.26%) 
Spinal osteoarthritis  1  1/395 (0.25%)  0/386 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour associated fever  1  2/395 (0.51%)  0/386 (0.00%) 
Gastrointestinal stromal tumour  1  1/395 (0.25%)  0/386 (0.00%) 
Infected neoplasm  1  1/395 (0.25%)  0/386 (0.00%) 
Thyroid cancer  1  1/395 (0.25%)  0/386 (0.00%) 
Nervous system disorders     
Headache  1  2/395 (0.51%)  3/386 (0.78%) 
Syncope  1  0/395 (0.00%)  4/386 (1.04%) 
Cerebrovascular accident  1  1/395 (0.25%)  2/386 (0.52%) 
Convulsion  1  2/395 (0.51%)  0/386 (0.00%) 
Dizziness  1  2/395 (0.51%)  0/386 (0.00%) 
Transient ischaemic attack  1  1/395 (0.25%)  1/386 (0.26%) 
Extrapyramidal disorder  1  0/395 (0.00%)  1/386 (0.26%) 
Haemorrhage intracranial  1  0/395 (0.00%)  1/386 (0.26%) 
Lethargy  1  1/395 (0.25%)  0/386 (0.00%) 
Loss of consciousness  1  0/395 (0.00%)  1/386 (0.26%) 
Nervous system disorder  1  0/395 (0.00%)  1/386 (0.26%) 
Neuralgia  1  1/395 (0.25%)  0/386 (0.00%) 
Partial seizures  1  0/395 (0.00%)  1/386 (0.26%) 
Peripheral motor neuropathy  1  0/395 (0.00%)  1/386 (0.26%) 
Polyneuropathy  1  1/395 (0.25%)  0/386 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/395 (0.25%)  0/386 (0.00%) 
Major depression  1  1/395 (0.25%)  0/386 (0.00%) 
Suicidal ideation  1  0/395 (0.00%)  1/386 (0.26%) 
Suicide attempt  1  1/395 (0.25%)  0/386 (0.00%) 
Renal and urinary disorders     
Proteinuria  1  0/395 (0.00%)  1/386 (0.26%) 
Renal colic  1  1/395 (0.25%)  0/386 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  4/395 (1.01%)  4/386 (1.04%) 
Dyspnoea  1  4/395 (1.01%)  3/386 (0.78%) 
Interstitial lung disease  1  3/395 (0.76%)  2/386 (0.52%) 
Lung disorder  1  1/395 (0.25%)  1/386 (0.26%) 
Pneumonitis  1  1/395 (0.25%)  1/386 (0.26%) 
Acute pulmonary oedema  1  1/395 (0.25%)  0/386 (0.00%) 
Acute respiratory distress syndrome  1  0/395 (0.00%)  1/386 (0.26%) 
Bronchiectasis  1  1/395 (0.25%)  0/386 (0.00%) 
Bronchospasm  1  0/395 (0.00%)  1/386 (0.26%) 
Cough  1  1/395 (0.25%)  0/386 (0.00%) 
Haemoptysis  1  1/395 (0.25%)  0/386 (0.00%) 
Organising pneumonia  1  0/395 (0.00%)  1/386 (0.26%) 
Pleural effusion  1  0/395 (0.00%)  1/386 (0.26%) 
Pleuritic pain  1  0/395 (0.00%)  1/386 (0.26%) 
Pulmonary oedema  1  1/395 (0.25%)  0/386 (0.00%) 
Respiratory failure  1  1/395 (0.25%)  0/386 (0.00%) 
Skin and subcutaneous tissue disorders     
Hidradenitis  1  1/395 (0.25%)  0/386 (0.00%) 
Skin ulcer  1  1/395 (0.25%)  0/386 (0.00%) 
Vascular disorders     
Hypertension  1  6/395 (1.52%)  1/386 (0.26%) 
Deep vein thrombosis  1  2/395 (0.51%)  4/386 (1.04%) 
Hypertensive crisis  1  2/395 (0.51%)  0/386 (0.00%) 
Circulatory collapse  1  0/395 (0.00%)  1/386 (0.26%) 
Haematoma  1  1/395 (0.25%)  0/386 (0.00%) 
Jugular vein thrombosis  1  0/395 (0.00%)  1/386 (0.26%) 
Shock haemorrhagic  1  1/395 (0.25%)  0/386 (0.00%) 
Thrombosis  1  1/395 (0.25%)  0/386 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Rituximab + CHOP Placebo + Rituximab + CHOP
Affected / at Risk (%) Affected / at Risk (%)
Total   346/395 (87.59%)   331/386 (85.75%) 
Blood and lymphatic system disorders     
Neutropenia  1  88/395 (22.28%)  119/386 (30.83%) 
Anaemia  1  66/395 (16.71%)  96/386 (24.87%) 
Leukopenia  1  42/395 (10.63%)  49/386 (12.69%) 
Thrombocytopenia  1  24/395 (6.08%)  30/386 (7.77%) 
Gastrointestinal disorders     
Nausea  1  107/395 (27.09%)  106/386 (27.46%) 
Diarrhoea  1  95/395 (24.05%)  81/386 (20.98%) 
Constipation  1  88/395 (22.28%)  70/386 (18.13%) 
Vomiting  1  56/395 (14.18%)  70/386 (18.13%) 
Stomatitis  1  33/395 (8.35%)  36/386 (9.33%) 
Dyspepsia  1  23/395 (5.82%)  35/386 (9.07%) 
Abdominal pain  1  32/395 (8.10%)  25/386 (6.48%) 
Abdominal pain upper  1  17/395 (4.30%)  32/386 (8.29%) 
Haemorrhoids  1  23/395 (5.82%)  12/386 (3.11%) 
General disorders     
Fatigue  1  71/395 (17.97%)  71/386 (18.39%) 
Pyrexia  1  71/395 (17.97%)  55/386 (14.25%) 
Asthenia  1  59/395 (14.94%)  60/386 (15.54%) 
Mucosal inflammation  1  61/395 (15.44%)  45/386 (11.66%) 
Oedema peripheral  1  24/395 (6.08%)  29/386 (7.51%) 
Infections and infestations     
Nasopharyngitis  1  30/395 (7.59%)  22/386 (5.70%) 
Urinary tract infection  1  24/395 (6.08%)  23/386 (5.96%) 
Upper respiratory tract infection  1  25/395 (6.33%)  17/386 (4.40%) 
Investigations     
Weight decreased  1  24/395 (6.08%)  21/386 (5.44%) 
Metabolism and nutrition disorders     
Decreased appetite  1  60/395 (15.19%)  46/386 (11.92%) 
Hypokalaemia  1  21/395 (5.32%)  17/386 (4.40%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  37/395 (9.37%)  37/386 (9.59%) 
Arthralgia  1  35/395 (8.86%)  19/386 (4.92%) 
Pain in extremity  1  22/395 (5.57%)  19/386 (4.92%) 
Bone pain  1  23/395 (5.82%)  17/386 (4.40%) 
Nervous system disorders     
Headache  1  59/395 (14.94%)  59/386 (15.28%) 
Neuropathy peripheral  1  38/395 (9.62%)  38/386 (9.84%) 
Paraesthesia  1  42/395 (10.63%)  31/386 (8.03%) 
Peripheral sensory neuropathy  1  25/395 (6.33%)  28/386 (7.25%) 
Dizziness  1  24/395 (6.08%)  21/386 (5.44%) 
Psychiatric disorders     
Insomnia  1  29/395 (7.34%)  30/386 (7.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  52/395 (13.16%)  43/386 (11.14%) 
Epistaxis  1  47/395 (11.90%)  10/386 (2.59%) 
Dyspnoea  1  19/395 (4.81%)  27/386 (6.99%) 
Oropharyngeal pain  1  27/395 (6.84%)  19/386 (4.92%) 
Rhinorrhoea  1  24/395 (6.08%)  14/386 (3.63%) 
Dysphonia  1  29/395 (7.34%)  7/386 (1.81%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  96/395 (24.30%)  80/386 (20.73%) 
Rash  1  22/395 (5.57%)  23/386 (5.96%) 
Vascular disorders     
Hypertension  1  54/395 (13.67%)  12/386 (3.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Due to premature termination of the study, the efficacy results should be interpreted with caution.
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00486759     History of Changes
Other Study ID Numbers: BO20603
First Submitted: June 14, 2007
First Posted: June 15, 2007
Results First Submitted: November 28, 2012
Results First Posted: December 31, 2012
Last Update Posted: July 25, 2017