Aggressive Non Hodgkin´s Lymphoma (NHL)
Conditions
Interventions
Trade Name: Mabthera 100mg
Product Name: MabThera
Product Code: RO 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
Current Sponsor code: RO45-2294
Con
Sponsors
AGMT: Arbeitsgemeinschaft Medikamentöse Tumortherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have received eight infusions of rituximab plus 4 – 8 cycles of CHOP-like chemotherapy including an anthracycline Induction treatment must have been completed with the application of the final cycle of chemotherapy or immunotherapy no longer than 12 weeks, and no earlier than 4 weeks before trial treatment start. Patients must have reached a complete remission (CR) or an unconfirmed CR (CRu) after induction therapy Histologic diagnosis of either diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3b according to the WHO/REAL classification at time of diagnosis (prior to induction therapy) Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy) ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV ) Known IPI at time of diagnosis (prior to induction therapy) Age 18 years or older Life expectancy of at least 3 months Be willing and able to comply with the protocol for the duration of the study Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period and during the 12 months thereafter. Patient’s written informed consent 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: First-line NHL therapy other than specified in the inclusion criteria More than one prior chemoimmunotherapy regimen. Histologies other than DLBCL and follicular lymphoma grade 3b according to the WHO/REAL classification Transfomed lymphoma History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma or carcinoma in situ of the cervix within the last 5 years. Major surgery, other than diagnostic surgery, within the last 4 weeks. Evidence of CNS involvement. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to study drugs. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months. Unacceptable hematologic status at baseline prior to study start below any of the values listed: WBC: 2 mg/dL (35 mmol/L); ALAT or ASAT >2.5 x upper limit of normal range; alkaline phosphatase > 3 x upper limit of normal range Abnormal renal function (serum creatinine > 2.0 mg/dL (177 µmol/L)). Patients with active opportunistic infections. HIV-positive patients. Life expectancy of less than 3 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS) ;Secondary Objective: Secondary objective: To evaluate Progression-free Survival (PFS), Overall Survival (OS) and Safety. ;Primary end point(s): Event-free survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or instituition of new anti-lymphoma treatment | — |
Countries
Czech Republic, Estonia, Latvia, Lithuania, Slovenia, Sweden
Outcome results
None listed