Prognosis of high-risk patients with diffuse large B-cell lymphoma is still less then optimal. According to revised Int. Prognostic Index, patients with 3-5 adverse prognostic factors have only about 50% chance of survival in 4 years. In theory, there are 3 possibilities how to improve prognosis of patients with poor-risk DLBCL: intensification of induction therapy, high-dose consolidation treatment with autologous stem cell transplant or combination of both methods.
Conditions
Interventions
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Solution for infusion
Sponsors
Czech Lymphoma Research Organization s.r.o. (CLRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-60 years • Newly diagnosed, CD20 positive, untreated diffuse large B-cell lymphoma or composite follicular/diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma (according to the WHO classification) • High intermediate or high risk according to age adjusted International Prognostic Index (aaIPI 2-3) • No significant organ dysfunction, no active uncontrolled disease • ECOG Performance Status 0-3 • Ejection fraction of at least 50% as determined by echocardiography or alternative suitable method • Signed 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: • Relapse of the lymphoma • CD20 negative diffuse large-cell lymphoma. • Post-transplant or other EBV-associated lymphoproliferative diseases. • Contraindication to any of planned treatments (for specific details refer to Summary of Product Characteristic (SPC) of each respective compound, including known hypersensitivity or allergy to murine products • Frank CNS involvement, diagnosed clinically, or by CT, NMR, or by unequivocal liquor positivity • Any history of malignant disease treated with chemotherapy or radiotherapy, with the exception of targeted radiotherapy for skin squamo-cellular carcinoma or basalioma. • Other serious disease or condition • HIV positivity, active hepatitis B or hepatitis C • Treatment within a clinical trial within 30 days prior to trial entry • Women who are breast-feeding, are not using effective contraception, are pregnant or do not agree not to become pregnant during the treatment phase and the 12 months thereafter. Men who do not agree not to father a child during the treatment phase and the 12 months thereafter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare PFS in arms treated with intensive immuno-chemotherapy followed by observation or by HDT and ASCT in early PET negative (PET-) pts and To determine safety and PFS of intensified salvage immuno-chemotherapy followed by HDT and ASCT in early PET positive (PET+) pts.;Secondary Objective: To compare EFS and OS in arms treated with intensified immuno-chemotherapy followed by observation or by HDT and ASCT in early PET negative pts To determine ORR, CR, EFS and OS of the intensified salvage immuno-chemotherapy followed by HDT and ASCT in early PET positive pts and compare PFS, EFS and OS with outcomes of the early PET negative patients.;Primary end point(s): PET negative part of the protocol: To compare progression free survival (PFS) between arms treated with rituximab-based immunochemotherapy followed by observation or by HDT + ASCT in early PET negative young (under 60) high intermediate or high risk (aaIPI 2-3) CD20+ DLBCL patients. PET positive part of the protocol: To determine safety and progression free survival (PFS) of rituximab-based salvage immunochemotherapy followed by HDT + ASCT in early PET positive young (under 60) high intermediate or high risk (aaIPI 2-3) CD20+ DLBCL patients. | — |
Countries
Czech Republic
Outcome results
None listed