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Trial record 78 of 877 for:    "Reticulum Cell Sarcoma"

Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-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: NCT00121199
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : December 19, 2012
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Interventions Biological: rituximab
Biological: bevacizumab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Other: laboratory biomarker analysis
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Period Title: Overall Study
Started 73
Eligible 64
Eligible and Began Protocol Therapy 64
Completed 45
Not Completed 28
Reason Not Completed
Adverse Event             11
Refusal Unrelated to Adverse Event             1
Progression/Relapse             1
Death             3
Other - Not Protocol Specified             3
Ineligible             9
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
67.6
(21.8 to 84.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
20
  31.3%
Male
44
  68.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Hispanic or Latino
2
   3.1%
Not Hispanic or Latino
57
  89.1%
Unknown or Not Reported
5
   7.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
American Indian or Alaska Native
2
   3.1%
Asian
2
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
   9.4%
White
54
  84.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Progression-free Survival at 1 Year
Hide Description Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Time Frame 0-1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description:
Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77
(66 to 87)
2.Primary Outcome
Title Progression-free Survival at 2 Year
Hide Description Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Time Frame 0-2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description:
Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(57 to 80)
3.Secondary Outcome
Title Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))
Hide Description Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time Frame After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who started treatment were included in the analysis
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description:
Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 22
Partial Response (PR) 20
Unconfirmed Complete Response (UCR) 6
Unconfirmed Partial Response (UPR) 1
No Response 15
4.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 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 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 CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description:
Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1
Allergic reaction/hypersensitivity 1
Anorexia 5
Cardiac General-Other (Specify) 1
Cardiac troponin I (cTnI) 1
Cardiopulmonary arrest, cause unknown (non-fatal) 1
Constipation 2
Dehydration 1
Distention/bloating, abdominal 1
Dry mouth/salivary gland (xerostomia) 1
Dyspnea (shortness of breath) 3
Fatigue (asthenia, lethargy, malaise) 8
Febrile neutropenia 11
Fever in absence of neutropenia, ANC lt1.0x10e9/L 1
Glucose, serum-high (hyperglycemia) 2
Hemoglobin 8
Hemolysis 1
Hemorrhage, GI - Colon 1
Hemorrhage, pulmonary/upper respiratory - Nose 2
Hypertension 4
Hypotension 2
Hypoxia 1
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 1
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 1
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS 1
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 1
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 2
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 1
Insomnia 1
Left ventricular diastolic dysfunction 1
Left ventricular systolic dysfunction 3
Leukocytes (total WBC) 28
Lymphopenia 10
Mucositis/stomatitis (clinical exam) - Oral cavity 2
Muscle weakness, not d/t neuropathy - body/general 2
Nausea 2
Neuropathy: motor 3
Neuropathy: sensory 1
Neutrophils/granulocytes (ANC/AGC) 33
Obstruction, GI - Jejunum 1
Pain - Abdomen NOS 4
Pain - Bone 1
Pain - Throat/pharynx/larynx 1
Perforation, GI - Jejunum 2
Perforation, GI - Small bowel NOS 1
Perforation, GI - Stomach 1
Platelets 12
Pneumonitis/pulmonary infiltrates 1
Pneumothorax 1
Potassium, serum-low (hypokalemia) 2
Pruritus/itching 1
Pulmonary/Upper Respiratory-Other (Specify) 2
Renal failure 1
Sodium, serum-low (hyponatremia) 3
Somnolence/depressed level of consciousness 1
Sudden death 2
Thrombosis/thrombus/embolism 4
Voice changes/dysarthria 1
Vomiting 1
Weight loss 1
Time Frame Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CHOP + Rituximab + Bevacizumab
Hide Arm/Group Description Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
All-Cause Mortality
CHOP + Rituximab + Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CHOP + Rituximab + Bevacizumab
Affected / at Risk (%)
Total   27/63 (42.86%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/63 (4.76%) 
Hemoglobin  1  3/63 (4.76%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1  2/63 (3.17%) 
Gastrointestinal disorders   
Constipation  1  2/63 (3.17%) 
Diarrhea  1  1/63 (1.59%) 
Distention/bloating, abdominal  1  1/63 (1.59%) 
Hemorrhage, GI - Colon  1  1/63 (1.59%) 
Mucositis/stomatitis (clinical exam) - Esophagus  1  1/63 (1.59%) 
Nausea  1  2/63 (3.17%) 
Pain - Abdomen NOS  1  2/63 (3.17%) 
Perforation, GI - Jejunum  1  2/63 (3.17%) 
Perforation, GI - Small bowel NOS  1  1/63 (1.59%) 
Perforation, GI - Stomach  1  1/63 (1.59%) 
Vomiting  1  1/63 (1.59%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  3/63 (4.76%) 
Pain-Other (Specify)  1  1/63 (1.59%) 
Sudden death  1  2/63 (3.17%) 
Infections and infestations   
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  1/63 (1.59%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Skin  1  1/63 (1.59%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/63 (1.59%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  2/63 (3.17%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lymphatic  1  1/63 (1.59%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav  1  1/63 (1.59%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  1/63 (1.59%) 
Injury, poisoning and procedural complications   
Fracture  1  1/63 (1.59%) 
Investigations   
Leukocytes (total WBC)  1  4/63 (6.35%) 
Lymphopenia  1  2/63 (3.17%) 
Neutrophils/granulocytes (ANC/AGC)  1  7/63 (11.11%) 
Platelets  1  3/63 (4.76%) 
Metabolism and nutrition disorders   
Anorexia  1  2/63 (3.17%) 
Dehydration  1  1/63 (1.59%) 
Potassium, serum-low (hypokalemia)  1  1/63 (1.59%) 
Sodium, serum-low (hyponatremia)  1  2/63 (3.17%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general  1  1/63 (1.59%) 
Pain - Bone  1  1/63 (1.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  1/63 (1.59%) 
Nervous system disorders   
Neuropathy: motor  1  1/63 (1.59%) 
Pain - Head/headache  1  1/63 (1.59%) 
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS)  1  1/63 (1.59%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  1/63 (1.59%) 
Pneumonitis/pulmonary infiltrates  1  2/63 (3.17%) 
Pneumothorax  1  1/63 (1.59%) 
Vascular disorders   
Hypertension  1  1/63 (1.59%) 
Hypotension  1  1/63 (1.59%) 
Thrombosis/thrombus/embolism  1  3/63 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CHOP + Rituximab + Bevacizumab
Affected / at Risk (%)
Total   60/63 (95.24%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  8/63 (12.70%) 
Hemoglobin  1  42/63 (66.67%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1  8/63 (12.70%) 
Gastrointestinal disorders   
Constipation  1  30/63 (47.62%) 
Diarrhea  1  19/63 (30.16%) 
Dry mouth/salivary gland (xerostomia)  1  5/63 (7.94%) 
Dysphagia (difficulty swallowing)  1  4/63 (6.35%) 
Heartburn/dyspepsia  1  7/63 (11.11%) 
Hemorrhoids  1  4/63 (6.35%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  20/63 (31.75%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  12/63 (19.05%) 
Nausea  1  25/63 (39.68%) 
Pain - Abdomen NOS  1  13/63 (20.63%) 
Vomiting  1  10/63 (15.87%) 
General disorders   
Edema: limb  1  9/63 (14.29%) 
Fatigue (asthenia, lethargy, malaise)  1  47/63 (74.60%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  13/63 (20.63%) 
Pain-Other (Specify)  1  9/63 (14.29%) 
Rigors/chills  1  12/63 (19.05%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  4/63 (6.35%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  13/63 (20.63%) 
AST, SGOT  1  15/63 (23.81%) 
Alkaline phosphatase  1  10/63 (15.87%) 
Bilirubin (hyperbilirubinemia)  1  6/63 (9.52%) 
Creatinine  1  8/63 (12.70%) 
Leukocytes (total WBC)  1  32/63 (50.79%) 
Lymphopenia  1  16/63 (25.40%) 
Neutrophils/granulocytes (ANC/AGC)  1  32/63 (50.79%) 
Platelets  1  26/63 (41.27%) 
Weight loss  1  14/63 (22.22%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  18/63 (28.57%) 
Anorexia  1  24/63 (38.10%) 
Calcium, serum-low (hypocalcemia)  1  14/63 (22.22%) 
Dehydration  1  8/63 (12.70%) 
Glucose, serum-high (hyperglycemia)  1  27/63 (42.86%) 
Magnesium, serum-low (hypomagnesemia)  1  5/63 (7.94%) 
Phosphate, serum-low (hypophosphatemia)  1  4/63 (6.35%) 
Potassium, serum-high (hyperkalemia)  1  6/63 (9.52%) 
Potassium, serum-low (hypokalemia)  1  9/63 (14.29%) 
Sodium, serum-low (hyponatremia)  1  17/63 (26.98%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue-Other (Specify)  1  5/63 (7.94%) 
Pain - Back  1  14/63 (22.22%) 
Pain - Bone  1  4/63 (6.35%) 
Pain - Joint  1  10/63 (15.87%) 
Pain - Muscle  1  8/63 (12.70%) 
Nervous system disorders   
Dizziness  1  6/63 (9.52%) 
Neuropathy: motor  1  5/63 (7.94%) 
Neuropathy: sensory  1  32/63 (50.79%) 
Pain - Head/headache  1  14/63 (22.22%) 
Taste alteration (dysgeusia)  1  11/63 (17.46%) 
Psychiatric disorders   
Insomnia  1  11/63 (17.46%) 
Mood alteration - anxiety  1  5/63 (7.94%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  7/63 (11.11%) 
Cough  1  12/63 (19.05%) 
Dyspnea (shortness of breath)  1  19/63 (30.16%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  15/63 (23.81%) 
Pain - Throat/pharynx/larynx  1  4/63 (6.35%) 
Pulmonary/Upper Respiratory-Other (Specify)  1  5/63 (7.94%) 
Voice changes/dysarthria  1  6/63 (9.52%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify)  1  4/63 (6.35%) 
Hair loss/Alopecia (scalp or body)  1  25/63 (39.68%) 
Nail changes  1  4/63 (6.35%) 
Sweating (diaphoresis)  1  9/63 (14.29%) 
Vascular disorders   
Hypertension  1  8/63 (12.70%) 
Hypotension  1  6/63 (9.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121199     History of Changes
Other Study ID Numbers: NCI-2012-03062
NCI-2012-03062 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S0515 ( Other Identifier: SWOG )
S0515 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2005
First Posted: July 21, 2005
Results First Submitted: October 30, 2012
Results First Posted: December 19, 2012
Last Update Posted: May 21, 2014