Diffuse Large B-Cell Lymphoma.Phase 2R-MCEBNCT00558220
R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
A Phase 2 study testing immunotherapy, Induction treatment part 1 and Induction treatment part 2 with PBPC collection in people with Diffuse Large B-Cell Lymphoma. and Primary Mediastinal B-Cell Lymphoma, run by Czech Lymphoma Study Group at 8 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma., Primary Mediastinal B-Cell Lymphoma, Follicular Lymphoma Grade III
- What is being tested?
- immunotherapy, Induction treatment part 1 and Induction treatment part 2 with PBPC collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 8 sitesCzechia
- Study dates
- May 2002to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Czechia8 sites
University Hospital Brno-Bohunice
Brno, 625 00
Hospital České Budějovice
České Budějovice
Hospital Chomutov
Chomutov, 430 12
University Hospital Hradec Králové
Hradec Králové, 500 05
University Hospital Královské Vinohrady
Prague, 100 34
General University Hospital
Prague, 128 08
University Hospital Motol
Prague, 150 00
Hospital Ústí nad Labem
Ústí nad Labem, 401 13
About this study
Official title: Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas
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.
Read the 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.
- Conditions
- Diffuse Large B-Cell Lymphoma., Primary Mediastinal B-Cell Lymphoma, Follicular Lymphoma Grade III
- Being tested
- immunotherapy, Induction treatment part 1, Induction treatment part 2 with PBPC collection, Induction treatment part 3, Consolidation treatment part 1: HD-chemotherapy with ASCT
- Keywords
- Lymphoma, B-cell, Immunotherapy, passive, Remission induction, Autologous transplantation
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapyProcedure or surgery
Given together with induction chemotherapy:
Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses
Induction treatment part 1Procedure or surgery
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 collectionProcedure or surgery
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 3Procedure or surgery
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 ASCTProcedure or surgery
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: RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy Receives: Procedure: immunotherapy; Procedure: Induction treatment part 1; Procedure: Induction treatment part 2 with PBPC collection; Procedure: Induction treatment part 3; Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCT; Radiation: Consolidation treatment part 2: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 3 years
Secondary outcomes (2)
Complete remission and overall response rate
Measured: One year
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startMay 2002
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Lymphoma Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Hoffmann-La Roche
- Investigators
- Pytlik Robert, M.D., Principal investigator, 1st Department of Medicine, General University Hospital, PragueMarek Trněný, M.D., PhD., Study director, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558220
- Sponsor's protocol ID
- CLSG 5_02
- Other IDs
- NR-8231/3
- Acronym
- R-MCEB
- Status last verified
- Nov 2007
- First submitted
- 12 Feb 2007
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00558220
- Acronym / sponsor ID
- R-MCEB / CLSG 5_02
- Conditions
- Diffuse Large B-Cell Lymphoma., Primary Mediastinal B-Cell Lymphoma, Follicular Lymphoma Grade III
- Keywords
- Lymphoma, B-cell, Immunotherapy, passive, Remission induction, Autologous transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Czech Lymphoma Study GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Hoffmann-La Roche
- Study start
- May 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: immunotherapy, Procedure: Induction treatment part 1, Procedure: Induction treatment part 2 with PBPC collection, Procedure: Induction treatment part 3, Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCT, Radiation: Consolidation treatment part 2: RadiotherapyIntensive induction followed by high-dose consolidation with stem cell support ± radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunotherapyGiven together with induction chemotherapy: Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses | Procedure or surgery | A |
| Induction treatment part 1cyclophosphamide 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 or surgery | A |
| Induction treatment part 2 with PBPC collectionStarts 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 or surgery | A |
| Induction treatment part 3Part 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 or surgery | A |
| Consolidation treatment part 1: HD-chemotherapy with ASCTConsolidation 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. | Procedure or surgery | A |
| Consolidation treatment part 2: RadiotherapyRadiotherapy 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. | Radiation | A |
Primary outcome
Progression-free survival
Time frame: 3 years
2 secondary outcomes
Complete remission and overall response rate
Time frame: One year
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
- Official Site of the Czech Lymphoma Study GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pytlik Robert, M.D. principal investigator
1st Department of Medicine, General University Hospital, Prague
Marek Trněný, M.D., PhD. study director
General University Hospital, Prague
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing immunotherapy, Induction treatment part 1 and Induction treatment part 2 with PBPC collection in people with Diffuse Large B-Cell Lymphoma. and Primary Mediastinal B-Cell Lymphoma, run by Czech Lymphoma Study Group at 8 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.