Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00558220
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00558220
Study Brief:
Protocol Section:
NCT00558220