PET-RIMCEB:Early PET adjusted rituximab-based intensified immunochemotherapy in young poor risk DLBCL patientsA phase III studyA randomized, open-label trial comparing intensified immunochemotherapy (Rituximab[R]-MegaCHOP/R-CHOP) with intensified immunochemotherapy (R-MegaCHOP/R-CHOP) followed by High Dose Therapy (BEAM) with autologous stem cell transplantation or observation in early PET negative young poor risk patients with CD20+ Diffuse Large B-Cell Lymphomas+A single arm trial of intensified platinum-based immunochemotherapy (R-MegaCHOP/R-Pt-based salvage regimen) followed by High Dose Therapy (BEAM) with autologous stem cell transplantation in early PET positive young poor risk patients with CD20+ Diffuse Large B-Cell Lymphomas - PET-RIMCEB

Conditions: 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.

Registration Number: EUCTR2009-016136-12-CZ

Lead Sponsor: Czech Lymphoma Research Organization s.r.o. (CLRO)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 280

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

•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.