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| ID | Type | Description | Link |
|---|---|---|---|
| NR-8231/3 |
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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| Hoffmann-La Roche | INDUSTRY |
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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.
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:
Exclusion criteria were:
Primary endpoints was progression-free survival
Secondary endpoints were:
Planned number of accrued patients was 100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunotherapy | Procedure | Given together with induction chemotherapy: Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission and overall response rate | One year | |
| Overall survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pytlik Robert, M.D. | 1st Department of Medicine, General University Hospital, Prague | Principal Investigator |
| Marek Trněný, M.D., PhD. | General University Hospital, Prague | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno-Bohunice | Brno | 625 00 | Czechia | |||
| Hospital Chomutov |
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| Label | URL |
|---|---|
| Official Site of the Czech Lymphoma Study Group | View source |
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| Induction treatment part 1 | Procedure | 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. |
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| Induction treatment part 2 with PBPC collection | Procedure | 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. |
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| Induction treatment part 3 | Procedure | 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. |
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| Consolidation treatment part 1: HD-chemotherapy with ASCT | Procedure | 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. |
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| Consolidation treatment part 2: Radiotherapy | Radiation | 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. |
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| Chomutov |
| 430 12 |
| Czechia |
| Hospital České Budějovice | České Budějovice | Czechia |
| University Hospital Hradec Králové | Hradec Králové | 500 05 | Czechia |
| University Hospital Královské Vinohrady | Prague | 100 34 | Czechia |
| General University Hospital | Prague | 128 08 | Czechia |
| University Hospital Motol | Prague | 150 00 | Czechia |
| Hospital Ústí nad Labem | Ústí nad Labem | 401 13 | Czechia |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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