None listed
Conditions
Interventions
This group will be treated with Rituximab in a dose of 275 mg / m2, in intravenous infusion every 8 weeks for 24 months (12 infusions) or until an event occurs.
Group name:BRANCH 2 Type of group
This group will be observed, without further intervention for 24 months (12 infusions) or until an event occurs.
Sponsors
AGMT-AUSTRIA,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have received eight infusions of rituximab plus 4-8 cycles of chemotherapy similar to CHOP as first-line therapy for NHL. 2. The induction treatment will conclude with the application of the final cycle of chemotherapy or immunotherapy of no more than 12 weeks and not less than 4 weeks before starting the therapeutic trial. 3. Patients will have achieved complete remission (CR) or unconfirmed CR (RCu) after induction treatment for remission. 4. Histological diagnosis of diffuse large B-cell lymphoma (DLBCL) or grade 3b follicular lymphoma. 5. Confirmed positivity to GD20 of the lymphoma at the time of diagnosis. 6. ECOG performance status of 0, 1 or 2 at the time of being included. 7. IPI known at the time of diagnosis. 8. 18 years of age or older. 9. Life expectancy of at least 3 months. 10. Disposition and capacity to comply with the study protocol. 11. Women of reproductive age should have a negative pregnancy test and accept the use of effective contraceptives throughout the treatment period and 12 months later. 12. Have informed consent of patients.
Exclusion criteria
Exclusion criteria: 1. Therapy for first-line NHL other than that specified in the inclusion criteria. 2. More than one previous chemotherapy regimen. 3. Histology other than DLBCL and grade 3b follicular lymphoma. 4. Presence of transformed lymphoma. 5. History of tumor other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix in the last 5 years. 6. Major surgery, different from diagnostic surgery, in the last 4 weeks. 7. Evidence of CNS affection. Patients with a history of uncontrollable seizures, central nervous system disorders or psychiatric disorders that the researcher deems clinically significant and that may adversely affect compliance with the administration of the drugs under study. 8. Presence of clinically significant heart disease or myocardial infarction in the last 6 months. 9. Hematological alterations in the baseline studies requested at the start of the study with values ​​below normal in any of the following parameters: leukocytes, absolute neutrophil count and platelets. 10 Abnormalities in liver function tests. 11. Renal insufficiency. 12. Patients with active opportunistic infections. 13. HIV-positive patients. 14. Intolerance to rituximab. 15. Active viral hepatitis, specifically HBV or HCV infection. 16. Severe underlying conditions that may impair the patient´s ability to participate in the trial. 17. Life expectancy <6 months. 18. Sensitivity or known allergy to products of murine origin. 19. Treatment in a clinical trial in the 30 days prior to entering this study. 20. The transformed form. 21. Women in the lactation stage, who do not use effective contraception, are pregnant or refuse not to get pregnant during the therapeutic trial phase and for 12 months thereafter. Men who refuse not to father a child during the treatment phase and 2 months thereafter. 22. Patients under guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation, in which the time from the beginning of the therapy to the appearance of an event will be determined. An event is defined as: progression, relapse (according to the criteria of Cheson et al.), Death from any cause, initiation of a new antilinfoma treatment, secondary malignancy or unacceptable toxicity. Measure:Event free survival (EFS). Timepoints:When the event is presented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Determination of time from the start of treatment to the onset of progressive disease or relapse (according to the criteria of Cheson et al.) Or death from any cause. Criterion 2: Determination of the time from the start of treatment to death from any cause. Measure:1) Free survival of progression. 2) Total survival. Timepoints:At 4 years old ; Outcome name:Questionnaire SF-12 version 2 ®. Measure:Quality of life. Timepoints:Weeks 0, 2, 4, 5, 7 and 9. ; Outcome name:Cell level: evolution over time of the concentration of B lymphocytes, CD3 +, CD4 +, CD19 +, CD3 + / 8 +, CD3 + / 4 +, GD16 + / 3- lymphocytes, and natural cytocidal cells in the patient s blood. Humoral level: by the evolution in time of the concentration of IgG, IgA and IgM in the blood, and by monitoring of Infections. Measure:Immunological competence. Timepoints:Weeks 1, 3, 4, 6, and 7. ; Outcome name:Clinical evaluation of any deterioration of the baseline condition of the patient that appear after the start of the treatment, regardless of whether it is considered related or not to the study medication. Measure:Security: Compilation of adverse events. Timepoints:Weeks 0, 1, 2, 3, 4, 5, 6, 7 and 8. | — |
Countries
Australia, Austria, Bosnial and Herzegovina, China, Croatia, Czech Republic, Estonia, Israel, Latovia, Macedonia, Malasya, Mexico, Romania, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Taiwan, Thailand, Turkey
Contacts
Public ContactPILAR LESLIE KIKUSHIMA
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed