R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
NCT ID: NCT00558220
Last Updated: 2007-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2002-05-31
2006-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy
immunotherapy
Given together with induction chemotherapy:
Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses
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.
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.
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.
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.
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.
Interventions
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immunotherapy
Given together with induction chemotherapy:
Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years
* Age-adjusted IPI score 2-3
* ECOG performance status 0-3
* Signed informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ministry of Health, Czech Republic
OTHER_GOV
Hoffmann-La Roche
INDUSTRY
Czech Lymphoma Study Group
OTHER
Principal Investigators
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Pytlik Robert, M.D.
Role: PRINCIPAL_INVESTIGATOR
1st Department of Medicine, General University Hospital, Prague
Marek Trněný, M.D., PhD.
Role: STUDY_DIRECTOR
General University Hospital, Prague
Locations
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University Hospital Brno-Bohunice
Brno, , Czechia
Hospital Chomutov
Chomutov, , Czechia
Hospital České Budějovice
České Budějovice, , Czechia
University Hospital Hradec Králové
Hradec Králové, , Czechia
University Hospital Královské Vinohrady
Prague, , Czechia
General University Hospital
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
Hospital Ústí nad Labem
Ústí nad Labem, , Czechia
Countries
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Related Links
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Official Site of the Czech Lymphoma Study Group
Other Identifiers
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NR-8231/3
Identifier Type: -
Identifier Source: secondary_id
CLSG 5_02
Identifier Type: -
Identifier Source: org_study_id