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Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell 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: NCT00301821
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : March 24, 2015
Last Update Posted : October 9, 2019
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
Condition Lymphoma
Interventions Biological: epratuzumab
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Enrollment 107
Recruitment Details For this study 107 patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were enrolled. Twenty-six (24%) patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.
Pre-assignment Details  
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
Period Title: Overall Study
Started 107
Completed 81
Not Completed 26
Reason Not Completed
Ineligible             25
Cancel             1
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
Overall Number of Baseline Participants 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 107 participants
62
(21 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants
Female
48
  44.9%
Male
59
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants
107
1.Primary Outcome
Title Event-free Survival After 12 Months
Hide Description The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
Time Frame From Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
First 76 eligible participants were included in this analysis.
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description:
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
Overall Number of Participants Analyzed 76
Measure Type: Number
Unit of Measure: percentage of participants
78
2.Secondary Outcome
Title Overall Survival
Hide Description Percentage of participants alive at different time points
Time Frame time from study entry to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (All Patients)
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description:
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of Participants
Overall Survival at 12 months 89
Overall Survival at 24 months 81
Overall Survival at 36 months 80
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Time Frame the time from study entry to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (All Patients)
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description:
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
Progression Free Survival at 12 months 85
Progression Free Survival at 24 months 77
Progression Free Survival at 36 months 76
4.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Time Frame Baseline to first 6 cycles of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description:
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: percentage of participants
95
Time Frame [Not Specified]
Adverse Event Reporting Description One patient canceled before beginning treatment.
 
Arm/Group Title Epratuzumab + Rituximab + CHOP
Hide Arm/Group Description One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
All-Cause Mortality
Epratuzumab + Rituximab + CHOP
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Epratuzumab + Rituximab + CHOP
Affected / at Risk (%) # Events
Total   72/106 (67.92%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  12/106 (11.32%)  16
Hemoglobin decreased  1  7/106 (6.60%)  8
Cardiac disorders   
Atrial fibrillation  1  1/106 (0.94%)  1
Left ventricular failure  1  1/106 (0.94%)  1
Sinus tachycardia  1  2/106 (1.89%)  2
Gastrointestinal disorders   
Cecal hemorrhage  1  1/106 (0.94%)  1
Diarrhea  1  2/106 (1.89%)  2
Gastic fistula  1  1/106 (0.94%)  1
Ileal hemorrhage  1  1/106 (0.94%)  1
Lower gastrointestinal hemorrhage  1  1/106 (0.94%)  1
Nausea  1  1/106 (0.94%)  1
Small intestinal obstruction  1  1/106 (0.94%)  2
Stomach pain  1  1/106 (0.94%)  1
Vomiting  1  2/106 (1.89%)  2
General disorders   
Chest pain  1  1/106 (0.94%)  1
Fatigue  1  3/106 (2.83%)  3
Fever  1  1/106 (0.94%)  1
Immune system disorders   
Cytokine release syndrome  1  1/106 (0.94%)  1
Infections and infestations   
Abdominal infection  1  1/106 (0.94%)  1
Bladder infection  1  1/106 (0.94%)  1
Eye infection  1  1/106 (0.94%)  1
Peritoneal infection  1  1/106 (0.94%)  1
Pneumonia  1  6/106 (5.66%)  6
Sepsis  1  1/106 (0.94%)  1
Skin infection  1  1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Vascular access complication  1  1/106 (0.94%)  1
Investigations   
Leukocyte count decreased  1  62/106 (58.49%)  136
Lymphocyte count decreased  1  2/106 (1.89%)  3
Neutrophil count decreased  1  67/106 (63.21%)  149
Platelet count decreased  1  9/106 (8.49%)  10
Metabolism and nutrition disorders   
Anorexia  1  1/106 (0.94%)  1
Blood glucose increased  1  2/106 (1.89%)  4
Dehydration  1  3/106 (2.83%)  3
Serum potassium decreased  1  2/106 (1.89%)  2
Serum sodium decreased  1  2/106 (1.89%)  2
Tumor lysis syndrome  1  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/106 (0.94%)  1
Muscle weakness  1  1/106 (0.94%)  1
Nervous system disorders   
Ischemia cerebrovascular  1  1/106 (0.94%)  1
Syncope  1  1/106 (0.94%)  1
Psychiatric disorders   
Confusion  1  2/106 (1.89%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/106 (3.77%)  4
Hypoxia  1  4/106 (3.77%)  4
Pleural effusion  1  1/106 (0.94%)  1
Pneumonitis  1  2/106 (1.89%)  2
Respiratory disorder  1  1/106 (0.94%)  1
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/106 (0.94%)  1
Vascular disorders   
Hypotension  1  2/106 (1.89%)  2
Thrombosis  1  5/106 (4.72%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epratuzumab + Rituximab + CHOP
Affected / at Risk (%) # Events
Total   105/106 (99.06%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  8/106 (7.55%)  9
Hemoglobin decreased  1  30/106 (28.30%)  68
Cardiac disorders   
Atrial fibrillation  1  1/106 (0.94%)  1
Left ventricular dysfunction  1  1/106 (0.94%)  1
Left ventricular failure  1  1/106 (0.94%)  1
Myocardial ischemia  1  1/106 (0.94%)  1
Sinus tachycardia  1  1/106 (0.94%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/106 (0.94%)  1
Endocrine disorders   
Hypothyroidism  1  1/106 (0.94%)  1
Eye disorders   
Vision blurred  1  1/106 (0.94%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/106 (0.94%)  1
Abdominal pain  1  3/106 (2.83%)  4
Constipation  1  6/106 (5.66%)  7
Diarrhea  1  9/106 (8.49%)  12
Dry mouth  1  1/106 (0.94%)  1
Dyspepsia  1  4/106 (3.77%)  6
Dysphagia  1  1/106 (0.94%)  1
Esophageal hemorrhage  1  1/106 (0.94%)  1
Flatulence  1  1/106 (0.94%)  6
Ileus  1  1/106 (0.94%)  1
Lower gastrointestinal hemorrhage  1  1/106 (0.94%)  1
Mucositis oral  1  9/106 (8.49%)  11
Nausea  1  12/106 (11.32%)  17
Oral pain  1  1/106 (0.94%)  1
Small intestinal obstruction  1  1/106 (0.94%)  1
Vomiting  1  28/106 (26.42%)  47
General disorders   
Chest pain  1  1/106 (0.94%)  1
Edema limbs  1  2/106 (1.89%)  2
Fatigue  1  36/106 (33.96%)  89
Fever  1  2/106 (1.89%)  2
General symptom  1  2/106 (1.89%)  2
Hepatobiliary disorders   
Cholecystitis  1  1/106 (0.94%)  1
Immune system disorders   
Cytokine release syndrome  1  14/106 (13.21%)  14
Hypersensitivity  1  2/106 (1.89%)  2
Infections and infestations   
Appendicitis  1  1/106 (0.94%)  1
Appendicitis perforated  1  1/106 (0.94%)  1
Bladder infection  1  2/106 (1.89%)  2
Conjunctivitis infective  1  1/106 (0.94%)  1
Gastric infection  1  1/106 (0.94%)  1
Gingival infection  1  3/106 (2.83%)  4
Infection  1  1/106 (0.94%)  1
Mucosal infection  1  1/106 (0.94%)  1
Pneumonia  1  4/106 (3.77%)  4
Skin infection  1  3/106 (2.83%)  3
Tooth infection  1  1/106 (0.94%)  1
Upper respiratory infection  1  3/106 (2.83%)  3
Urinary tract infection  1  1/106 (0.94%)  1
Viral hepatitis  1  1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Vascular access complication  1  1/106 (0.94%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  1/106 (0.94%)  1
Alanine aminotransferase increased  1  1/106 (0.94%)  1
Alkaline phosphatase increased  1  1/106 (0.94%)  2
Aspartate aminotransferase increased  1  2/106 (1.89%)  3
Blood bilirubin increased  1  1/106 (0.94%)  1
Creatinine increased  1  2/106 (1.89%)  2
Leukocyte count decreased  1  88/106 (83.02%)  326
Lymphocyte count decreased  1  7/106 (6.60%)  23
Neutrophil count decreased  1  78/106 (73.58%)  200
Platelet count decreased  1  71/106 (66.98%)  260
Weight gain  1  3/106 (2.83%)  10
Weight loss  1  4/106 (3.77%)  7
Metabolism and nutrition disorders   
Anorexia  1  9/106 (8.49%)  12
Blood glucose increased  1  18/106 (16.98%)  32
Dehydration  1  5/106 (4.72%)  5
Serum albumin decreased  1  3/106 (2.83%)  3
Serum calcium decreased  1  6/106 (5.66%)  6
Serum glucose decreased  1  1/106 (0.94%)  1
Serum phosphate decreased  1  1/106 (0.94%)  1
Serum potassium decreased  1  1/106 (0.94%)  1
Serum sodium decreased  1  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/106 (2.83%)  3
Back pain  1  2/106 (1.89%)  2
Bone pain  1  4/106 (3.77%)  4
Muscle weakness  1  2/106 (1.89%)  2
Muscle weakness lower limb  1  1/106 (0.94%)  2
Muscle weakness right-sided  1  1/106 (0.94%)  1
Myalgia  1  4/106 (3.77%)  4
Pain in extremity  1  1/106 (0.94%)  1
Trismus  1  1/106 (0.94%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplasia  1  1/106 (0.94%)  8
Tumor pain  1  1/106 (0.94%)  1
Nervous system disorders   
Dysgeusia  1  3/106 (2.83%)  8
Headache  1  1/106 (0.94%)  2
Memory impairment  1  1/106 (0.94%)  2
Neurological disorder NOS  1  1/106 (0.94%)  1
Peripheral motor neuropathy  1  3/106 (2.83%)  3
Peripheral sensory neuropathy  1  50/106 (47.17%)  199
Syncope vasovagal  1  1/106 (0.94%)  1
Taste alteration  1  1/106 (0.94%)  2
Tremor  1  1/106 (0.94%)  1
Psychiatric disorders   
Agitation  1  1/106 (0.94%)  1
Depression  1  3/106 (2.83%)  4
Insomnia  1  4/106 (3.77%)  4
Renal and urinary disorders   
Bladder obstruction  1  1/106 (0.94%)  1
Cystitis  1  1/106 (0.94%)  2
Kidney pain  1  1/106 (0.94%)  1
Urinary frequency  1  1/106 (0.94%)  1
Urinary incontinence  1  2/106 (1.89%)  2
Reproductive system and breast disorders   
Prostatic obstruction  1  1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/106 (0.94%)  1
Bronchospasm  1  1/106 (0.94%)  1
Cough  1  1/106 (0.94%)  1
Dyspnea  1  7/106 (6.60%)  7
Hiccups  1  1/106 (0.94%)  1
Hypoxia  1  3/106 (2.83%)  3
Pharyngolaryngeal pain  1  1/106 (0.94%)  1
Pleural effusion  1  3/106 (2.83%)  3
Pneumonitis  1  3/106 (2.83%)  3
Respiratory disorder  1  1/106 (0.94%)  1
Voice alteration  1  1/106 (0.94%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  40/106 (37.74%)  150
Hand-and-foot syndrome  1  1/106 (0.94%)  1
Pruritus  1  1/106 (0.94%)  1
Skin disorder  1  1/106 (0.94%)  2
Sweating  1  2/106 (1.89%)  4
Vascular disorders   
Hypertension  1  1/106 (0.94%)  1
Hypotension  1  3/106 (2.83%)  3
Thrombosis  1  3/106 (2.83%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ivana N. M. Micallef, M.D.
Organization: Mayo Clinic
Phone: 507-284-4642
EMail: micallef.ivana@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00301821    
Other Study ID Numbers: NCCTG-N0489
NCI-2012-02685 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000459932 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: March 13, 2015
Results First Posted: March 24, 2015
Last Update Posted: October 9, 2019