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

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

May 31, 2002

Study Completion Date

October 31, 2006

Conditions
Diffuse Large B-Cell Lymphoma.Primary Mediastinal B-Cell LymphomaFollicular 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.

Trial Locations (8)

625 00

University Hospital Brno-Bohunice, Brno

430 12

Hospital Chomutov, Chomutov

Unknown

Hospital České Budějovice, České Budějovice

500 05

University Hospital Hradec Králové, Hradec Králové

100 34

University Hospital Královské Vinohrady, Prague

128 08

General University Hospital, Prague

150 00

University Hospital Motol, Prague

401 13

Hospital Ústí nad Labem, Ústí nad Labem

All Listed Sponsors
collaborator

Ministry of Health, Czech Republic

OTHER_GOV

collaborator

Hoffmann-La Roche

INDUSTRY

lead

Czech Lymphoma Study Group

OTHER

NCT00558220 - R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas | Biotech Hunter | Biotech Hunter