Previously untreated diffuse large B-cell non-Hodgkin's lymphoma
Conditions
Interventions
Trade Name: Avastin
Product Name: bevacizumab
Product Code: RO4876646
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Other descripti
Sponsors
Royal Marsden NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age at least 18 years. b) Histological proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to the current World Health Organization classification20 including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel. c) No previous chemotherapy, radiotherapy or other investigational drug for this indication. d) Stage II, III and IV disease e) WHO performance status 0 100x109/l; neutrophils > 1.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma. g) Serum creatinine 3 months. l) Adequate contraceptive precautions for all patients of childbearing potential m) Written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Lymphomatous involvement of, or lymphoma arising in the gastrointestinal tract. b)T-cell lymphoma or transformed follicular lymphoma. c) Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed with an indolent lymphoma, who have diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included. d) Past history of heart failure or uncontrolled angina pectoris. e) Central nervous system, meningeal involvement or cord compression by lymphoma. f) Absence of clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents ( 325mg/day) or nonsteroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases) • No chronic treatment with corticosteroids (dose of = 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids) • No known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, or to any other components of the study drugs • No proteinuria at baseline as defined by >1g of protein/24 hr by a 24-hour urine collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of adding bevacizumab to the standard combination of R-CHOP in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL). This will be evaluated by the primary end point which is the incidence of bevacizumab-specific toxicities and cardiotoxicity observed (according to CTC-AE version 3.0).;Secondary Objective: • Response rates (according to the International Workshop Standardized Response Criteria for Non-Hodgkin’s Lymphoma, see Section 10); • Failure free survival; • Overall survival; • Overall toxicity of treatment (according to CTCAE v 3.0). ;Primary end point(s): • Cardiac and bevacizumab-specific toxicity (according to CTCAE v 3.0) | — |
Countries
United Kingdom
Outcome results
None listed