CNS Prophylaxis in Diffuse Large B-cell Lymphoma (CLSG-CNS-001)
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|ClinicalTrials.gov Identifier: NCT02777736|
Recruitment Status : Unknown
Verified June 2016 by Czech Lymphoma Study Group.
Recruitment status was: Recruiting
First Posted : May 19, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Methotrexate||Phase 3|
Patients with diffuse large B-cell lymphoma are evaluated for risk factors of CNS relapse during initial staging (age > 60years, lactate dehydrogenase (LDH) > reference range, clinical stage III/IV, performance status according to Eastern Cooperative Oncology Group (ECOG) >1, kidney and/or adrenal gland involvement, involvement > 1 extranodal organ) including evaluation of cerebrospinal fluid.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Evaluating Relapses in Central Nervous System in Patients With Diffuse Large B-Cell Lymphoma Treated With Chemotherapy With or Without CNS Prophylaxis. Multicentric, Prospective, Randomized Phase III Study|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: 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).
i.v. or intrathecal CNS prophylaxis
Active Comparator: 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).
i.v. or intrathecal CNS prophylaxis
No Intervention: Arm C - no Methotrexate
Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.
- Cumulative incidence of CNS relapse in patients treated either with methotrexate i.v. or methotrexate i.t. or without CNS prophylaxis [ Time Frame: 1 year ]
- Complete remission rate [ Time Frame: 1 year ]
- Overall response rate [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 2 years ]
- Progression-free survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777736
|Contact: Heidi Mocikova, M.D., Ph.D.||+email@example.com|
|University Hospital Brno-Bohunice||Recruiting|
|Brno, Czech Republic, 62500|
|Contact: Andrea Janikova, M.D.,Ph.D.|
|University Hospital Hradec Králové||Recruiting|
|Hradec Králové, Czech Republic, 50005|
|Contact: David Belada, M.D., Ph.D.|
|University Hospital Ostrava||Recruiting|
|Ostrava, Czech Republic, 708 52|
|Contact: Juraj Ďuraš, M.D.|
|University Hospital Pilsen||Recruiting|
|Pilsen, Czech Republic, 304 60|
|Contact: Martin Pachner, M.D.|
|University Hospital Kralovske Vinohrady||Recruiting|
|Prague, Czech Republic, 100 34|
|Contact: Heidi Mocikova, M.D., Ph.D.|
|General University Hospital Prague||Recruiting|
|Prague, Czech Republic, 12808|
|Contact: Robert Pytlik, M.D.|
|Principal Investigator:||Heidi Mocikova, M.D., Ph.D.||University Hospital Kralovske Vinohrady, Prague, Czech Republic|
|Study Director:||Marek Trněný, prof.M.D.||General University Hospital, Prague|