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Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00049036
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 22, 2011
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions AIDS-related Diffuse Large Cell Lymphoma
AIDS-related Immunoblastic Large Cell Lymphoma
AIDS-related Peripheral/Systemic Lymphoma
AIDS-related Small Noncleaved Cell Lymphoma
Interventions Biological: rituximab
Drug: etoposide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Other: laboratory biomarker analysis
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Hide Arm/Group Description Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
Period Title: Overall Study
Started 51 55
Completed 51 55
Not Completed 0 0
Arm/Group Title EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab Total
Hide Arm/Group Description Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 51 55 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
54
  98.2%
105
  99.1%
>=65 years
0
   0.0%
1
   1.8%
1
   0.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 55 participants 106 participants
42.6  (8.4) 42.6  (9.4) 42.6  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
Female
8
  15.7%
7
  12.7%
15
  14.2%
Male
43
  84.3%
48
  87.3%
91
  85.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 55 participants 106 participants
51 55 106
1.Primary Outcome
Title Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
Hide Description Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Hide Arm/Group Description:
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: proportion
0.69 0.53
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Hide Arm/Group Description Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
All-Cause Mortality
EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/51 (54.90%)      27/55 (49.09%)    
Blood and lymphatic system disorders     
Coagulopathy  1/51 (1.96%)  6 0/55 (0.00%)  0
Febrile neutropenia  7/51 (13.73%)  8 7/55 (12.73%)  8
Hemoglobin decreased  2/51 (3.92%)  6 1/55 (1.82%)  6
Hemolysis  0/51 (0.00%)  0 1/55 (1.82%)  1
Hemorrhage  2/51 (3.92%)  7 0/55 (0.00%)  0
Leukopenia  4/51 (7.84%)  12 6/55 (10.91%)  9
Lymphopenia  1/51 (1.96%)  2 0/55 (0.00%)  0
Neutropenia  9/51 (17.65%)  15 9/55 (16.36%)  10
Platelet count decreases  2/51 (3.92%)  7 2/55 (3.64%)  4
Cardiac disorders     
Hypotension  3/51 (5.88%)  3 1/55 (1.82%)  1
Myocardial ischemia  1/51 (1.96%)  1 1/55 (1.82%)  1
Gastrointestinal disorders     
Abdominal pain  2/51 (3.92%)  2 2/55 (3.64%)  2
Anorexia  1/51 (1.96%)  2 0/55 (0.00%)  0
Colitis  1/51 (1.96%)  2 0/55 (0.00%)  0
Constipation  1/51 (1.96%)  1 1/55 (1.82%)  1
Diarrhea  3/51 (5.88%)  3 5/55 (9.09%)  5
Gastritis  1/51 (1.96%)  1 0/55 (0.00%)  0
Ileus  0/51 (0.00%)  0 1/55 (1.82%)  1
Nausea  1/51 (1.96%)  1 4/55 (7.27%)  6
Vomiting  1/51 (1.96%)  1 3/55 (5.45%)  4
General disorders     
Death  1/51 (1.96%)  1 0/55 (0.00%)  0
Dehydration  3/51 (5.88%)  10 2/55 (3.64%)  3
ENT exam abnormal  0/51 (0.00%)  0 2/55 (3.64%)  2
Fatigue  1/51 (1.96%)  1 1/55 (1.82%)  1
Fever  4/51 (7.84%)  12 5/55 (9.09%)  7
Headache  0/51 (0.00%)  0 2/55 (3.64%)  2
Lymphatic disorder  1/51 (1.96%)  2 0/55 (0.00%)  0
Multi-organ failure  1/51 (1.96%)  9 0/55 (0.00%)  0
Pain  1/51 (1.96%)  1 0/55 (0.00%)  0
Immune system disorders     
Autoimmune disorder  1/51 (1.96%)  1 0/55 (0.00%)  0
Infections and infestations     
Bone infection  0/51 (0.00%)  0 1/55 (1.82%)  1
Catheter related infection  1/51 (1.96%)  1 3/55 (5.45%)  3
Flu-like symptoms  1/51 (1.96%)  2 0/55 (0.00%)  0
Infection  10/51 (19.61%)  20 6/55 (10.91%)  8
Infectious meningitis  1/51 (1.96%)  1 0/55 (0.00%)  0
Pneumonia  0/51 (0.00%)  0 2/55 (3.64%)  2
Skin infection  1/51 (1.96%)  3 0/55 (0.00%)  0
Wound infection  0/51 (0.00%)  0 1/55 (1.82%)  1
Metabolism and nutrition disorders     
Aspartate aminotransferase increased  1/51 (1.96%)  1 0/55 (0.00%)  0
Hyperbilirubinemia  0/51 (0.00%)  0 2/55 (3.64%)  2
Hyperglycemia  1/51 (1.96%)  2 0/55 (0.00%)  0
Hypocalcemia  0/51 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Back pain  0/51 (0.00%)  0 1/55 (1.82%)  2
Bone pain  2/51 (3.92%)  2 1/55 (1.82%)  1
Fracture  0/51 (0.00%)  0 1/55 (1.82%)  2
Muscle weakness  1/51 (1.96%)  8 1/55 (1.82%)  1
Nervous system disorders     
Confusion  2/51 (3.92%)  2 0/55 (0.00%)  0
Depressed level of consciousness  1/51 (1.96%)  8 0/55 (0.00%)  0
Dizziness  2/51 (3.92%)  2 0/55 (0.00%)  0
Neurological disorder  0/51 (0.00%)  0 1/55 (1.82%)  1
Peripheral sensory neuropathy  0/51 (0.00%)  0 1/55 (1.82%)  1
Seizure  2/51 (3.92%)  9 0/55 (0.00%)  0
Syncope  1/51 (1.96%)  1 0/55 (0.00%)  0
Tremor  1/51 (1.96%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Renal failure  1/51 (1.96%)  2 0/55 (0.00%)  0
Urinary frequency  0/51 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Chest pain  1/51 (1.96%)  1 0/55 (0.00%)  0
Cough  1/51 (1.96%)  1 0/55 (0.00%)  0
Dyspnea  2/51 (3.92%)  9 0/55 (0.00%)  0
Hiccough  1/51 (1.96%)  3 0/55 (0.00%)  0
Hypoxia  0/51 (0.00%)  0 1/55 (1.82%)  1
Respiratory disorder  1/51 (1.96%)  6 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  0/51 (0.00%)  0 2/55 (3.64%)  2
Injection site reaction  1/51 (1.96%)  1 0/55 (0.00%)  0
Pruritus  0/51 (0.00%)  0 1/55 (1.82%)  1
Rash desquamation  1/51 (1.96%)  1 0/55 (0.00%)  0
Skin disorder  2/51 (3.92%)  2 0/55 (0.00%)  0
Vascular disorders     
Thrombosis  1/51 (1.96%)  1 1/55 (1.82%)  1
1
Term from vocabulary, meddra
2
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EPOCH + Concurrent Rituximab EPOCH Followed by Rituximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/51 (98.04%)      51/55 (92.73%)    
Blood and lymphatic system disorders     
Blood disorder  4/51 (7.84%)  45 5/55 (9.09%)  12
Febrile neutropenia  8/51 (15.69%)  9 9/55 (16.36%)  13
Hemoglobin decreases  22/51 (43.14%)  141 28/55 (50.91%)  172
Leukopenia  21/51 (41.18%)  142 23/55 (41.82%)  207
Lymphopenia  10/51 (19.61%)  91 10/55 (18.18%)  142
Neutropenia  28/51 (54.90%)  100 30/55 (54.55%)  133
Platelet count decreases  14/51 (27.45%)  58 20/55 (36.36%)  112
Cardiac disorders     
Hypotension  13/51 (25.49%)  14 2/55 (3.64%)  2
Sinus tachycardia  7/51 (13.73%)  26 3/55 (5.45%)  6
Gastrointestinal disorders     
Abdominal pain  14/51 (27.45%)  25 18/55 (32.73%)  40
Anorexia  10/51 (19.61%)  24 10/55 (18.18%)  14
Constipation  17/51 (33.33%)  32 20/55 (36.36%)  42
Diarrhea  17/51 (33.33%)  57 22/55 (40.00%)  33
Dyspepsia  4/51 (7.84%)  4 4/55 (7.27%)  5
ENT examination abnormal  10/51 (19.61%)  22 9/55 (16.36%)  14
Nausea  31/51 (60.78%)  85 24/55 (43.64%)  79
Taste alteration  6/51 (11.76%)  10 0/55 (0.00%)  0
Vomiting  20/51 (39.22%)  50 20/55 (36.36%)  42
General disorders     
Dehydration  6/51 (11.76%)  23 9/55 (16.36%)  13
Edema, limbs  1/51 (1.96%)  2 5/55 (9.09%)  6
Fatigue  25/51 (49.02%)  58 23/55 (41.82%)  57
Fever  23/51 (45.10%)  56 18/55 (32.73%)  31
Headache  21/51 (41.18%)  48 17/55 (30.91%)  46
Insomnia  6/51 (11.76%)  13 13/55 (23.64%)  20
Lymphatic disorder  5/51 (9.80%)  10 6/55 (10.91%)  18
Oral pain  4/51 (7.84%)  13 2/55 (3.64%)  2
Pain  6/51 (11.76%)  9 7/55 (12.73%)  16
Sweating  11/51 (21.57%)  15 13/55 (23.64%)  29
Weight loss  7/51 (13.73%)  14 11/55 (20.00%)  17
Hepatobiliary disorders     
Hyperbilirubinemia  4/51 (7.84%)  12 10/55 (18.18%)  25
Immune system disorders     
Allergic rhinitis  6/51 (11.76%)  19 5/55 (9.09%)  7
Infections and infestations     
Gingival infection  7/51 (13.73%)  9 3/55 (5.45%)  4
Infection  16/51 (31.37%)  44 23/55 (41.82%)  30
Metabolism and nutrition disorders     
Alanine aminotransferase increases  13/51 (25.49%)  30 19/55 (34.55%)  62
Alkaline phosphatase increases  11/51 (21.57%)  29 17/55 (30.91%)  43
Aspartate aminotransferase increased  14/51 (27.45%)  41 15/55 (27.27%)  55
Hyperglycemia  14/51 (27.45%)  64 16/55 (29.09%)  55
Hypoalbuminemia  7/51 (13.73%)  23 9/55 (16.36%)  19
Hypoglycemia  3/51 (5.88%)  12 5/55 (9.09%)  15
Hypocalcemia  7/51 (13.73%)  25 14/55 (25.45%)  41
Hypokalemia  11/51 (21.57%)  26 11/55 (20.00%)  42
Hypomagnesemia  3/51 (5.88%)  8 4/55 (7.27%)  7
Hyponatremia  9/51 (17.65%)  23 8/55 (14.55%)  14
Musculoskeletal and connective tissue disorders     
Back pain  6/51 (11.76%)  9 7/55 (12.73%)  22
Bone pain  7/51 (13.73%)  20 7/55 (12.73%)  13
Muscle weakness  3/51 (5.88%)  12 3/55 (5.45%)  7
Myalgia  4/51 (7.84%)  9 11/55 (20.00%)  15
Neck pain  3/51 (5.88%)  4 6/55 (10.91%)  7
Pain in extremity  7/51 (13.73%)  8 5/55 (9.09%)  16
Nervous system disorders     
Anxiety  11/51 (21.57%)  25 7/55 (12.73%)  19
Confusion  5/51 (9.80%)  6 6/55 (10.91%)  9
Depression  9/51 (17.65%)  13 4/55 (7.27%)  9
Dizziness  8/51 (15.69%)  9 7/55 (12.73%)  18
Peripheral motor neuropathy  2/51 (3.92%)  10 4/55 (7.27%)  6
Peripheral sensory neuropathy  16/51 (31.37%)  57 20/55 (36.36%)  76
Renal and urinary disorders     
Urogenital disorder  3/51 (5.88%)  4 3/55 (5.45%)  8
Respiratory, thoracic and mediastinal disorders     
Chest pain  6/51 (11.76%)  9 7/55 (12.73%)  10
Chills  8/51 (15.69%)  10 6/55 (10.91%)  12
Cough  8/51 (15.69%)  25 9/55 (16.36%)  17
Dyspnea  7/51 (13.73%)  24 10/55 (18.18%)  14
Hiccough  7/51 (13.73%)  12 2/55 (3.64%)  3
Skin and subcutaneous tissue disorders     
Alopecia  16/51 (31.37%)  46 16/55 (29.09%)  39
Dry skin  4/51 (7.84%)  4 4/55 (7.27%)  8
Pruritus  3/51 (5.88%)  6 6/55 (10.91%)  10
Rash desquamation  13/51 (25.49%)  32 9/55 (16.36%)  14
Skin disorder  8/51 (15.69%)  18 5/55 (9.09%)  26
Vascular disorders     
Thrombosis  3/51 (5.88%)  3 3/55 (5.45%)  5
1
Term from vocabulary, MedDRA (10.0)
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
Name/Title: Jeannette Lee
Organization: AIDS Malignancy Consortium
Phone: 501-526-6712
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049036     History of Changes
Other Study ID Numbers: NCI-2012-02926
NCI-2012-02926 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-AMC34
CDR0000257660
AMC-034 ( Other Identifier: AIDS - Associated Malignancies Clinical Trials Consortium )
AMC-034 ( Other Identifier: CTEP )
U01CA070019 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2002
First Posted: January 27, 2003
Results First Submitted: May 23, 2011
Results First Posted: June 22, 2011
Last Update Posted: May 14, 2014