Untreated grade 1 and 2 Follicular Lymphoma
Conditions
Interventions
Trade Name: MabThera®
Product Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Fundacion Leucemia y Linfoma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 and = 75 years. - Grade 1 or 2 Follicular Lymphoma, Marginal Zone Lymphoma or Lymphocitic Lymphoma (with no CLL criteria) confirmed by nodal tissue. Patients with diagnosis made in bone marrow trephine will be accepted, if no adenopathy is detected and MCL or CLL are ruled out. - Follicular Lymphoma International Prognostic Index (FLIPI) = 2. - No prior chemotherapy of radiotherapy. Local radiation is accepted. - Adequate hepatic and renal function (acceted if related to LNH infiltration) - Correct Thyroid function - ECOG performance status 0 to 3. - Abscence of other malignancies or impariment to receive thge drugs in the study. - Signed approved informed consent before any study specific procedures are performed. 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: - Prior chemotherapy of radiotherapy. - Active second malignancy in the previous 5 years. - Previous Psiquiatric disease, specially moderate to severe depression, psycosis, autolytic attempts. - Uncontrolled current cardiopathy (myocardial infarction, angina, significant cardiac arrythmia or congestive heart failure) - Diabetes mellitus insulin requirement. - Uncontrolled hepatic or autoimmune disease. - Female subjects who are breast-feeding - Female subjects, who are not surgically sterile or post-menopausal, and do not use medically acceptable methods of birth control for the duration of the study and for one year after the last dose. - Acute or ongoing chronic infectious disease. - Immunocopromised subjects including subjects known to be HIV possitive or acute/chronic HCV or HBV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment;Secondary Objective: Secondary endpoints in this study are to evaluate: - objective Response Rates - Overall Survival (OS) and Overall Specific Survival (OSS) - Molecular remission and follow-up of Minimal Residual Disease (MRD). - Safety and Tolerability of the combination ;Primary end point(s): The main end point of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment. | — |
Countries
Spain
Outcome results
None listed