Clinical trial NCT00558220: R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
Official title: Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma.
Primary Mediastinal B-Cell Lymphoma
Follicular Lymphoma Grade III
Keywords: Lymphoma, B-cell
Immunotherapy, passive
Remission induction
Autologous transplantation
Lead sponsor: Czech Lymphoma Study Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
name: Hoffmann-La Roche
First posted: 2007-11-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Complete remission and overall response rate
timeFrame: One year
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: University Hospital Brno-Bohunice
city: Chomutov
country: Czech Republic
facility: Hospital Chomutov
city: Hradec Králové
country: Czech Republic
facility: University Hospital Hradec Králové
city: Prague
country: Czech Republic
facility: University Hospital Královské Vinohrady
city: Prague
country: Czech Republic
facility: General University Hospital
city: Prague
country: Czech Republic
facility: University Hospital Motol
city: Usti nad Labem
country: Czech Republic
facility: Hospital Ústí nad Labem
city: České Budějovice
country: Czech Republic
facility: Hospital České Budějovice
Study officials:
affiliation: 1st Department of Medicine, General University Hospital, Prague
name: Pytlik Robert, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital, Prague
name: Marek Trněný, M.D., PhD.
role: STUDY_DIRECTOR
References: