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

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.

Conditions

• Diffuse Large B-Cell Lymphoma.
• Primary Mediastinal B-Cell Lymphoma
• Follicular Lymphoma Grade III

Interventions

PROCEDURE

immunotherapy

Given together with induction chemotherapy: Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses

PROCEDURE

Induction treatment part 1

cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks. 3 cycles consisting of combination treatment of above mentioned drugs are given.

PROCEDURE

Induction treatment part 2 with PBPC collection

Starts three weeks after last cycle of Induction part 1. Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection. Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are \>20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood.

PROCEDURE

Induction treatment part 3

Part 3 of induction treatment is given approximately one week after the end of Part 2. Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart.

PROCEDURE

Consolidation treatment part 1: HD-chemotherapy with ASCT

Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3. High dose chemotherapy (HD-chemotherapy) consists of: BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6. On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery.

RADIATION

Consolidation treatment part 2: Radiotherapy

Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (\>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.

Sponsors & Collaborators

• Ministry of Health, Czech Republic

  collaborator OTHER_GOV

• Hoffmann-La Roche

  collaborator INDUSTRY

• Czech Lymphoma Study Group

  lead OTHER

Principal Investigators

• Pytlik Robert, M.D. · 1st Department of Medicine, General University Hospital, Prague

• Marek Trněný, M.D., PhD. · General University Hospital, Prague

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-05-31

Completion

2006-10-31

Countries

• Czechia

Study Locations