Patients with Diffuse Large B Cell Lymphoma. Level: PT Classification code 10012826
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cyclophosphamide
Concentration type
Sponsors
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 61553; Age 18-60 61553; Diagnosis of B DLCL CD 20 new diagnosis or shift from low grade NHL not pre-treated or grade 3b Follicular Lymphoma 61553; Stage II advanced, III, IV with two or more risk factors 61553; Age-adjusted IPI 2-3 61553; PS 3 not due to the lymphoma 61553; Cardiac ejection fraction 45 61553; No impairment of renal, hepatic and pulmonary function 61553; Markers HIV, HBV e HCV negative 61553; HCV if without replication signs, istologically confirmed 61553; AntiHBc , HbsAg-, AntiHBs /- portatori occulti with HBV-DNA negative or weakly positive 61553; Life espectation 3 months 61553; No pregnancy at the start of chemotherapy 61553; Writted 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 61553; Lymphoblastic NHL 61553; Burkitt s Lymphoma 61553; CD20 negative Lymphoma 61553; Follicular or Mantle Lymphoma 61553; Primitive mediastinic Lymphoma with only intrathoracic localization 61553; Age 60 61553; Stage I 61553; Age-adjusted IPI 0-1 61553; PS 3 if not due to the Lymphoma 61553; Creatinine 1.2 mg/dl o creatinine clearance 60 ml/min. 61553; AST/ALT o bilirubine 2.5 the normal value if not due to the Lymphoma. 61553; Serious arterial hypertension not controlled, cardiac arrhythmia not controlled, symptomatic ventricular arrhytmias, congestive heart failure classe NYHA classe III-IV, acute myocardial infarction. 61553; Ventricular ejecton fractionr 45 61553; Important pulmonary disease. Impairment of pulmonary function BPCO, pulmonary fibrosis, TBC 61553; No evidence of active opportunistic infection 61553; HIV positivity 61553; HBV positivity 61553; AntiHBc , HbsAg-, AntiHBs /- with HBV-DNA positive 61553; HCV positivity with active replication signs HCV , PCR , AST 1.5-2x normal 61553; No evidence of symptomatic CNS disease 61553; No prior diagnosis of neoplasm within 3 years, except cervical intraepithelial neoplasia type 1 CIN1 or localized non-melanomatous skin cancer or localized prostatic carcinoma surgically treated, good prognosis DCIS only surgically treated 61553; Pregnancy at the start of chemotherapy 61553; No appropriate contraceptive method in women of childbearing potential or men during the chemotherapy and next six months. 61553; Psychiatric illness precluding understanding concepts of the trial or signing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if a dose-dense chemotherapy Rituximab high-dose intensified chemotherapy with ASCT R-MegaCHOP14/R-CHOP14 R-MAD BEAM and ASCT improve prognosis FFS at two years in comparison of a dose-dense chemotherapy Rituximab without intensification phase and ASCT R-MegaCHOP14/R-CHOP14 .;Secondary Objective: 1. To evaluate the Overall Survival difference at three years between a dose-dense chemotherapy Rituximab high-dose intensified chemotherapy with ASCT R-MegaCHOP14/R-CHOP14 R-MAD BEAM and ASCT and a dose-dense chemotherapy Rituximab without intensification phase and ASCT R-MegaCHOP14/R-CHOP14 . 2. To evaluate the efficacy of two different dose-dense chemotherapy Rituximab standard dose R-CHOP14 or intensified dose R-MegaCHOP14 with FFS at two years. 3. To evaluate the total response and the complete remission after 4 chemotherapy cicles between two different dose-dense chemotherapy Rituximab standard dose R-CHOP14 or intensified dose R-MegaCHOP14 . 4. To evaluate the FFS at two years efficacy of 4 chemotherapy arms exploratory analysis .;Primary end point(s): Measurement of FFS, evaluating failure as not response after first 4 cycles of dose-dense chemotherapy, not complete response at the end of treatment, progression in any phase of the therapy, relapse or dead due to any cause. FFS includes all patients and its duration is calculated from the randomization date to the date of appearance of the event or to the last follow-up date without events. | — |
Countries
Italy
Outcome results
None listed