PHASE III RANDOMIZED, OPEN LABEL STUDY OF SINGLE AGENT OFATUMUMAB VS. SINGLE AGENT RITUXIMAB IN FOLLICULAR LYMPHOMA RELAPSED AFTER RITUXIMAB-CONTAINING THERAPY

Not Applicable

• Conditions: -C82 Follicular lymphoma; Follicular lymphoma; C82

• Registration Number: PER-072-10
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Follicular lymphoma (FL): grades 1, 2 and 3A, defined according to the guidelines of the World Health Organization (WHO). The Grade 3B FL (absence of centrocytes) is not eligible for this study. The histology and expression of the CD20 receptor in the tumor cells should be verified with the pathological review of a current or previous lymph node biopsy. A bone marrow biopsy is not enough for diagnosis in tissues.
• Rituximab sensitive FL, defined as a partial or complete response to treatment with rituximab or with im regimen that includes rituximab lasting at least 6 months after completing the last treatment with rituximab. (Note: patients must have received at least 4 musions of rituximab given as a single agent or at least 3 cycles of a combination chemotherapy regimen that includes rituximab).
• Relapse or progression of the disease after a response to a prior therapy based on rituximab, as defined by the revised response criteria for malignant lymphomas (RRCML, Revised Response Criteria for Malignant Lymphoma) in 2007, where the need for a therapy is indicated.
• Radiographically measurable disease, defined as the presence of at least one clearly demarcated lesion, with a maximum diameter> 2.0 cm in the study by computed tomography (CT) images.
• Performance condition according to the Eastern Oncology Cooperative Group (ECOG) of O, 1 or 2.
• Age> 18 years.
• Life expectancy in at least 6 months, in the opinion of the researcher.
• The patient or his legal representative must be able to grant written informed consent before any specific study test or procedure is performed.
• All non-hematological toxicities related to previous treatment (with the exception of alopecia) must have been resolved according to CTCAE (version 4.0) at a score <2 at the time of randomization. (The hematological parameters are described in Section 4.1.3 Section 11.)

Exclusion Criteria

• Previous treatment with ofatumumab.
• Radioimnuiioterapia (RIT) prior within 6 months prior to randomization. Patients who have previously received a RIT must have obtained a partial or complete response lasting at least 6 months; and must have recovered from any hematological or other toxicity.
• Autologous stem cell transplant within 6 months before randomization.
• Previous allogeneic stem cell transplant.
• A previous therapy against lymphoma with monoclonal antibodies (excluding rituximab), chemotherapy, glucocorticoids or some other systemic treatment for lymphoma during the 3 months prior to randomization.
• Current or previous participation in another clinical intervention study within 4 weeks prior to randomization.
• Presence of other current or previous malignancy within 2 years prior to randomization. Patients who have been free of malignancies for at least 2 years, or who have a history of a non-melanoma skin cancer that has been completely resected or with a carcinoma in situ that has been successfully treated are eligible.
• Presence of a chronic or currently active infectious disease that requires systemic antibiotic, antifungal or antiviral treatment, such as, but not limited to the following conditions: chronic kidney infection, chronic lung infection with bronchiectasis, tuberculosis, active hepatitis C; and disease documented by the human immunodeficiency virus (HIV). All patients positive for HIV infection are excluded from the present study, regardless of whether they have a disease that defines acquired immunodeficiency syndrome (AIDS) and / or if they were receiving antiretroviral therapy.
• Clinically significant heart disease according to the investigator´s criteria, including the following conditions: unstable angina, acute myocardial infarction during the 6 months prior to randomization, congestive heart failure and arrhythmia requiring treatment.
• Other significant concurrent uncontrolled medical conditions, including but not limited to kidney, liver, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, brain or psychiatric diseases; which, in the opinion of the researcher, must have an impact on the patient´s participation in the study.
• Documented or suspected ability to fully comply with the study protocol.
• Liver disease or currently active biliary disease (with the exception of Gilbert´s syndrome or the presence of asymptomatic gallstones).
• Positive serblogy for hepatitis B, defined as a positive test result for the aforementioned virus surface antigen (HBsAg, hepatitis B surface antigen). Additionally, if the result is negative for HBsAg but positive for HBcAg (regardless of the state of the first), a test will be performed for deoxy-carbonucleic acid (DNA) of the hepatitis B virus; and, if positive, the patient will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified