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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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2015-07-31
2019-12-31
Brief Summary
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Detailed Description
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All patients with systemic DLBCL without CNS involvement are treated with systemic chemotherapy: either 6 cycles of R CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednison) +2xR (rituximab) or 6 cycles of DA EPOCH R (dose adjusted etoposide, prednison, vincristin, cyclophosphamide, doxorubicin) +2xR (rituximab). Patients with ≥ 2 risk factors for CNS relapse or with occult meningeal involvement will be randomized in 1:1 ratio either into arm A with 2 cycles of prophylactic methotrexate 3g/m2 i.v., or into arm B with prophylactic 6x intrathecal methotrexate 12mg (1x intrathecal methotrexate in each cycle of systemic chemotherapy). Patients with 0-1 risk factor will be allocated into arm C without CNS prophylaxis. Patients will be observed for CNS relapse during the follow-up of 1year after the end of the first-line treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A - Methotrexate i.v.
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive 2 cycles of methotrexate 3g/m2 i.v. after the 3rd and 6th cycle of systemic chemotherapy (R CHOP or DA EPOCH R).
Methotrexate
i.v. or intrathecal CNS prophylaxis
Arm B - Methotrexate i.t.
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive intrathecal methotrexate 12mg in each cycle of systemic chemotherapy (6x).
Methotrexate
i.v. or intrathecal CNS prophylaxis
Arm C - no Methotrexate
Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.
No interventions assigned to this group
Interventions
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Methotrexate
i.v. or intrathecal CNS prophylaxis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-72 years
* signed informed consent with the study
* first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR
Exclusion Criteria
* PMBL (primary mediastinal B-cell lymphoma)
* treatment with another chemotherapy than R CHOP or DA EPOCH R
* HIV positive, or active hepatitis B or C
* other concomitant serious disease (based on the decision of the physician-investigator)
* non-compliance of a patient
* any contraindication for application of anthracycline based chemotherapy or high dose methotrexate
* pregnancy or breast-feeding
18 Years
72 Years
ALL
No
Sponsors
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Czech Lymphoma Study Group
OTHER
Responsible Party
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Principal Investigators
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Heidi Mocikova, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Kralovske Vinohrady, Prague, Czech Republic
Marek Trněný, prof.M.D.
Role: STUDY_DIRECTOR
General University Hospital, Prague
Locations
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University Hospital Brno-Bohunice
Brno, , Czechia
University Hospital Hradec Králové
Hradec Králové, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
University Hospital Pilsen
Pilsen, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
General University Hospital Prague
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Andrea Janikova, M.D.,Ph.D.
Role: primary
David Belada, M.D., Ph.D.
Role: primary
Juraj Ďuraš, M.D.
Role: primary
Martin Pachner, M.D.
Role: primary
Heidi Mocikova, M.D., Ph.D.
Role: primary
Robert Pytlik, M.D.
Role: primary
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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Official Site of the Czech Lymphoma Study Group
Other Identifiers
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2015-000591-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLSG-CNS-001
Identifier Type: -
Identifier Source: org_study_id
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