Patients with B-DLCL relapsed or refractory after first line of therapy MedDRA version: 9.1 Level: LLT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-
Sponsors
GIMURELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 2. Diagnosis of CD20+ B-diffuse large cell de novo or transformed 3. Stage II, III, IV according to Ann Arbor criteria 4. Chemoresistant disease after first line treatment (CHOP-like ± Rituximab) or relapsed patients after one line of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation 5. Performance status 0-2 according to WHO criteria 6. HIV negativity 1. Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min. 8. Neutrophils count  1.5 x 109/l, Haemoglobin  9 g/dl, Platelets  150 x 109/l and bone marrow involvement 6 months 13. 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: 1. More than one line of prior chemotherapy before study entry 2. Prior high dose chemotherapy and autologous stem cell transplantation 3. HIV positivity 4. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 5. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmedHistory of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the 1-year event free survival (EFS) of patients treated with two repeated dosed of 90Y-Ibritumomab Tiuxetan (Zevalin) after standard salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma not eligible for HDC and ASCT.;Secondary Objective: To evaluate overall and complete response rate, 2-year event-free survival rate and 2-year overall survival rate of patients with relapsed/refractory aggressive lymphoma non-eligible for HDC and ASCT treated with standard salvage therapy and two repeated doses of 90Y-Ibritumomab Tiuxetan. To evaluate toxicity and safety of two doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma not elegible for HDC and ASCT;Primary end point(s): To evaluate the 1-year event free survival (EFS) of patients treated with two repeated dosed of 90Y-Ibritumomab Tiuxetan (Zevalin) after standard salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma not eligible for HDC and ASCT. | — |
Countries
Italy
Outcome results
None listed