None listed
Conditions
Interventions
It plans to add approximately 900 patients over a period of about 12 months.
The total study duration is approximately 3.5 years, based on an integration period of 12 months, an induction period of
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: 1. Signing the informed consent form 2. Age ≥ 18 and ≤ 80 years 3. DLBCL CD20 + or CD20 + follicular NHL grade 1, 2 or 3a according to the classification system of WHO histologically confirmed and previously untreated 4. Patients with a score of 1-4 or IPI IPI score of 0 with large tumor disease, defined as a lesion ≥ 7.5 cm, or FLIPI (low, intermediate or high) 5. At least one bidimensionally measurable lesions defined as> 1.5 cm in greatest dimension in CT scanning 6. Functional status according to the Eastern Cooperative Oncology Group (ECOG) ≤ 3.
Exclusion criteria
Exclusion criteria: 1. Transformed follicular lymphoma or IIIB 2. Primary lymphoma of the central nervous system, blastic variant of mantle cell lymphoma (MCL), histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL or DLBCL primary testicular 3. History of other malignancy that could interfere with the observance of the protocol or the interpretation of results. This includes a tumor that has been treated but not for healing, unless the tumor has been in remission without treatment for ≥ 5 years prior to study entry. Note: Patients with a history of squamous or basal cell carcinoma or melanoma skin or carcinoma in situ of the cervix treated with curative intent will be considered eligible. 4. Prior to the treatment or follicular NHL DLBCL except lymph node biopsy or local irradiation 5. Previous treatment with cytotoxic agents (with the exception of methotrexate for CNS prophylaxis in DLBCL) or rituximab by another disease (eg, rheumatoid arthritis) or previous use of an anti-CD20 6. Use of any monoclonal antibody within 3 months prior to randomization 7. Chemotherapy or other experimental treatment within 28 days prior to randomization 8. Poor liver function 9. Poor hematologic function 10. Poor liver function, 11. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known hypersensitivity or allergy to murine products 12. For patients with DLBCL - Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin, and prednisone), including previous treatment with anthracyclines 13. Other serious underlying pathology, at the discretion of the investigator, may affect the patient´s ability to participate in the study (eg, significant cardiovascular disease, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) 14. Recent major surgery (within 4 weeks prior to randomization) that was not for diagnostic 15. Bacterial, viral, fungal, mycobacterial, parasitic or other active infection and / or severe (excluding fungal infections of nail beds) or another severe episode of infection requiring IV antibiotics or hospitalization (related to the completion of the course of antibiotics except if tumor fever) within 4 weeks prior to randomization 16. Active infection by the hepatitis B virus (HBV) or the hepatitis C virus (HCV) (during selection should be discarded) 17. Background seropositive human immunodeficiency virus (HIV).
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hungary, Indonesia, Italy, Korea North, Korea South, Malasya, New Zealand, Norway, Panama, Philippines, Portugal, Romania, Sweden, Switzerland, Taiwan, Thailand, Turkey
Contacts
Public ContactHedwing Schmidt
ROCHE FARMA (PERU) S.A.
Outcome results
None listed