Trial Information

Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas

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.