R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
The purpose of this study is to show if addition of Rituximab to intensive induction
 (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall
 survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.
Previous study of Czech Lymphoma Study Group (4_2002)have shown that intensive induction
 (MegaCHOP - Cyclophosphamide 3 g/m2, Vincristine 2 mg, Adriamycin 75 mg/m2, Prednisone 300
 mg/m2 every three weeks with G-CSF for three cycles, followed by ESHAP - Etoposide 240 mg/m2,
 Cisplatin 100 mg/m2, Solumedrol 2000 mg and cytarabine 2000 mg/m2 for three cycles every
 three weeks with G-CSF) followed by intensive consolidation (BEAM) and stem cell support
 improves progression-free survival in adult patients (18-65 years old) with aggressive B-cell
 lymphoma (namely, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and
 follicular lymphoma grade II) with aaIPI 2 and namely, with aaIPI 3. This study was aimed to
 find out if addition of four to six doses of Rituximab 375 mg/m2 on first day of every cycle
 of intensive induction further improves prognosis of these patients.

 Inclusion criteria for this trial were:

 -  newly diagnosed aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma,
 primary mediastinal B-cell lymphoma and follicular lymphoma grade III

 -  age 18-65 years

 -  age adjusted IPI (International Prognostic Index) score 2 or 3

 -  ECOG performance status 0-3

 -  signed informed consent

 Exclusion criteria were:

 -  relapsed lymphoma

 -  previous treatment (up to one cycle of standard pretreatment - COP, CHOP or steroids was
 permitted and later became mandatory to decrease disease burden and/or improve the
 performance status of the patient)

 -  Burkitt lymphoma

 -  posttransplant lymphoproliferation

 -  CNS involvement

 -  other malignant tumor in previous history, except basalioma, skin squamocellular
 carcinoma or cervical carcinoma in situ

 -  other serious comorbidity

 Primary endpoints was progression-free survival

 Secondary endpoints were:

 -  rate of complete remission and overall response rate

 -  overall survival

 -  toxicity of the protocol, measured as grade III-IV toxicity and/or inability to finish
 the protocol as planned

 Planned number of accrued patients was 100.
Inclusion Criteria:

 -  Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal
 B-cell lymphoma, follicular lymphoma grade III

 -  Age 18-65 years

 -  Age-adjusted IPI score 2-3

 -  ECOG performance status 0-3

 -  Signed informed consent

 Exclusion Criteria:

 -  Burkitt lymphoma

 -  Posttransplant lymphoproliferation

 -  Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or
 steroids permitted and latter mandatory to decrease tumor burden and/or improve
 performance status)

 -  Other tumor in previous history with the exception of basalioma, squamous cell
 carcinoma of the skin or cervical carcinoma in situ

 -  Pregnancy/lactation

 -  CNS involvement

 -  Other serious comorbidities