SWOG clinical trial number
S0515
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Closed
Phase
Accrual
100%
Published
Abbreviated Title
NON-HODGKIN'S: R-CHOP + Bevacizumab for Adv Stage Diffuse Large B-cell NHL
Activated
06/15/2005
Closed
09/15/2008
Participants
Research committees
Lymphoma
Treatment
Rituximab
Bevacizumab
CHOP
Eligibility Criteria Expand/Collapse
Must have previously untreated Stage III, IV, or bulky Stage II diffuse large B-cell NHL that is CD20+; adequate sections from the original diagnostic specimen must be available for submission for pathology review; specimens for analysis of angiogenic markers must be submitted to the University of Arizona per Section 15.3; must be >= age 18; must have bidimensionally measurable disease; any non-measurable disease must be assessed within 42 days prior to registration; unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days prior to registration; CT scan of the chest/abdomen and pelvis within 28 days prior to registration; any laboratory or radiographic tests performed to assess CNS involvement must be negative; no previous diagnosis of indolent lymphoma; must not have received prior chemotherapy, radiation, or antibody-based therapy for lymphoma; PS=0-2; serum LDH measured within 28 days prior to registration; cardiac ejection fraction >=45% by MUGA scan or 2d-ECHO with no significant abnormalities; ANC>1000/mcL, platelets>100,000/mcL; urine proteinuria >= +1 or urine protein:creatinine ratio >= 1, a 24hr urine protein should be obtained, and the level < 1gm/24 hr to be eligible; no history of hypersensitivity to products containing Polysorbate 20 (Tween 20), Chinese hamster ovary cell products, or recombinant human antibodies; must not be HIV+ or have a history of solid organ transplantation; patients at high risk of Hepatitis B virus (HBV) infection should be screened prior to the initiation of rituximab; must not have uncontrolled hypertension; no history of myocardial infarction, unstable angina, stroke, or arterial thrombosis; must not have clinically significant peripheral vascular disease, a serious or non-healing wound, ulcer or bone fracture, or a bleeding diathesis/coagulopathy; must not have a history of venous thrombosis requiring full-dose anticoagulation or currently receiving anticoagulation therapy; must not have had a major surgical procedure or traumatic injury within 28 days prior to registration; must not have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months; must not be requiring continuous supplemental oxygen therapy; no prior malignancy except basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for >= 5 years; must not be pregnant or nursing; patients may not participate unless they have agreed to use an effective contraceptive method during the study period and for at least 6 months after the completion of therapy;
Publication Information Expand/Collapse
2017
PMid: PMID28615297 | PMC number: PMC6574129
2016
Beyond RCHOP: A blueprint for diffuse large B-cell lymphoma research
PMid: PMID27986884 | PMC number: pending
2012
PMid: PMID22734071 | PMC number: PMC3418716
2010
Phase II trial of standard dose cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and Rituximab (R-CHOP) plus bevacizumab for advanced stage diffuse large B-cell (DLBCL) NHL: Southwest Oncology Group study S0515
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