None listed
Conditions
Interventions
Group 1 Type of group
Total of 8 treatment cycles, each with a duration
of 14 days:
Cycle 1: bevacizumab 10 mg / kg Day 0: Rituximab
375mg / m2 IV Day 1, cyclophosphamide 50 mg / m2 IV Day 1, doxorubicin 50 mg / m2 IV Day 1, vincristine 1.4 mg / m2 IV (max 2 mg) Day 1, prednisone 100 mg p.o. Day 1-5.
Cycle 2 to 6
Group 2 Type of group
Total of 8 treatment cycles, each with a duration
of 14 days:
Cycle 1 to 6: Rituximab 375 mg / m2 IV Day 1, cyclophosphamide
50mg / m2 IV Dial, doxorubicin 50mg / m2 IV Dial,
vincristine 1.4mg / m2 IV (max 2mg) Dial, prednisone
100 mgp.o. Day 1-5.
Cycle 7 to 8: Rituximab 375 mg / m2 of IV Day 1.
Radiotherapy can be applied at the initial sites of
voluminous tumor according to institutional practice.
Any radiotherapy must be planned beforehand
of randomization.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent • Age> 18 years • Diffuse large CD20 positive B-cell lymphoma (DLBCL) or histological variants according to the WHO classification Low-to-intermediate, high to intermediate or high risk according to the IPI score and / or bulky tumors (diameter) greater than> 7.5 cm) regardless of the IPI score • Two-dimensionally measurable disease • Degree of activity (ECOG) O to 2 • Cardiac ejection fraction> 50% as measured by MUGA or 2D-ECH0 without clinically significant abnormalities • Adequate haematological function: hemoglobin> 9g / dL absolute neutrophil count> 1,500 / pL and platelet count> 100,000 / uL, unless the abnormalities are due to the lymphoma affecting the bone marrow • Adequate renal function as documented by: a serum creatinine concentration 6 months • You must have a negative pregnancy test one week before treatment for both premenopausal women and women <2 years after the onset of menopause or within 14 days with a confirmatory urine pregnancy test within a period of 1 week before the start of the study treatment
Exclusion criteria
Exclusion criteria: • NHL transformed or NHL types other than: DLBCL and its subtypes according to the WHO classification • Pre-treatment for DLBCL • CNS involvement due to lymphoma or any evidence of compression of the spine. CT / MRI of the brain is only mandatory (within 4 weeks before randomization) in case of clinical suspicion of CNS involvement due to lymphoma. • Evidence of invasion of the tumor by CT of the main blood vessels (which puts the patient at risk of bleeding during the study treatment) • Affectation of the digestive system due to lymphoma. Note that endoscopy is not a mandatory procedure prior to the study for all patients. • Seopositivity for Hepatitis B unless it is clearly due to the vaccine (the Hepatitis B test is not mandatory, but is highly recommended) • Knowledge of HIV infection (the HIV test is not mandatory in this study) • Active viral, bacterial or fungal infection • History of solid organ transplantation • Pregnancy or lactating women • Men and women of childbearing age ( NYHA Grade IV), thrombosis within 6 months before enrollment , CHF> NYHA Grade II, or severe cardiac arrhythmia that requires ongoing treatment • Clinically significant active peripheral vascular disease, serious wound / ulcer that does not heal, bone fracture, bleeding diathesis (history or evidence of hereditary bleeding diathesis) or coagulopathy • Major surgery, open biopsy or trauma within 28 days before enrollment (lymph node biopsies are not considered major surgery), or the need for major surgery during the course of the study treatment • History of active ulcer (within 1 year before randomization), abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess or simultaneous treatment for ulcer treatment / prevention • Current or recent treatment (within 30 days prior to the start of study treatment with another investigational medication) or participation in another therapeutic research study • Evidence of any other disease, metabolic insufficiency, finding on physical examination or clinical laboratory findings that of a reasonable suspicion of a disease or condition that contraindicates the use of a research drug, or patient at high risk of treatment complications • Any coexisting medical or physiological condition that could compromise the ability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PFS is measured as the time from the date of randomization to the date of disease progression / relapse or death. Measure:Efficacy in terms of survival without progression Timepoints:After the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The main analysis of response rates will be based on the evaluation of final response after completing immunochemotherapy (cycles 6 or 8) or after completing radiotherapy in patients who received previously planned irradiation. Measure:Global response rate Timepoints:After completing treatment ; Outcome name:The full response rates will be analyzed in the same way as the overall response rate. The analysis of the response rates will be carried out, including evaluation by PET as exploratory analyzes with scientific purposes. Measure:Complete response rate Timepoints:After treatment ; Outcome name:Overall survival is measured as the time from the randomization date to the date of death. Patients without an event will be excluded on the last date they were known to be alive. Measure:Overall survival Timepoints:from the randomization date to the date of death ; Outcome name:Free event survival is measured as the time from the randomization date to the date of a therapeutic failure event with events that are defined as • Relapse of the disease • Progression of the disease • Death • New antilinfoma treatment; whatever happens first. Measure:Event free survival Timepoints:After treatment ; Outcome name:Disease-free survival is measured from the first documented complete response date to the first time of relapse or death in patients who achieve a complete response. Measure:Disease-free survival Timepoints:from the first documented complete response date to the first time of relapse or death | — |
Countries
Austria, Czech Republic, France, Germany, Greece, Hungary, Italy, Lithuania, Peru, Poland, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactClaudia Machicado
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed