R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas (R-MCEB)

Czech Lymphoma Study Group

Status and phase

Completed

Phase 2

Conditions

Primary Mediastinal B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma.

Follicular Lymphoma Grade III

Treatments

Procedure: Induction treatment part 1

Procedure: immunotherapy

Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCT

Procedure: Induction treatment part 2 with PBPC collection

Procedure: Induction treatment part 3

Radiation: Consolidation treatment part 2: Radiotherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00558220

NR-8231/3

CLSG 5_02

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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