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

Phase 2

Completed

• Conditions: Diffuse Large B-Cell Lymphoma.; Primary Mediastinal B-Cell Lymphoma; Follicular Lymphoma Grade III
• Interventions: Procedure: immunotherapy; Procedure: Induction treatment part 1; Procedure: Induction treatment part 2 with PBPC collection; Procedure: Induction treatment part 3

• Registration Number: NCT00558220
• Lead Sponsor: Czech Lymphoma Study Group

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 Timeline

• Study Start: 2002-05
• Study Completion: 2006-10
• Study First Submitted: 2007-02-12
• Status Verified: 2007-11
• Study First Submitted QC: 2007-11-10
• Last Update Submitted: 2007-11-10
• Study First Posted: 2007-11-14
• Last Update Posted: 2007-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	immunotherapy	Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy
A	Induction treatment part 1	Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy
A	Induction treatment part 2 with PBPC collection	Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy
A	Induction treatment part 3	Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Complete remission and overall response rate	One year
Overall survival	3 years

Trial Locations

Locations (8)

University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czech Republic

University Hospital Brno-Bohunice; 🇨🇿 Brno, Czech Republic

Hospital Chomutov; 🇨🇿 Chomutov, Czech Republic

University Hospital Královské Vinohrady; 🇨🇿 Prague, Czech Republic

General University Hospital; 🇨🇿 Prague, Czech Republic

University Hospital Motol; 🇨🇿 Prague, Czech Republic

Hospital Ústí nad Labem; 🇨🇿 Usti nad Labem, Czech Republic

Hospital České Budějovice; 🇨🇿 České Budějovice, Czech Republic