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Rituximab + methotrexate followed by rituximab + cytarabine in elderly patients with primary CNS lymphoma
KCT0003146Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2018
- Countries
- 1
- Sponsor
- Celltrion
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
- Conditions
- primary central nervous system lymphoma (PCNSL)
01
Overview
Phase 2, open-label, single-arm trial of rituximab, methotrexate and cytarabine in primary central nervous system lymphoma (PCNSL), sponsored by Celltrion. Primary endpoint: 2-year progression-free survival rate. Started Jul 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single treatment arm
Response-adapted induction rituximab + methotrexate followed by consolidation rituximab + cytarabine.
03
Who it enrols
Eligible patients are adults aged 60 years or older with newly diagnosed, measurable, histologically proven primary central nervous system B-cell non-Hodgkin lymphoma confined to the CNS, cranial nerves, and/or eyes, who are unfit for high-dose chemotherapy with autologous stem cell transplantation and have adequate organ function. Prior lymphoma treatment is not allowed except diagnostic tumorectomy and glucocorticoids; systemic lymphoma, T-cell or NK/T-cell lymphoma, prior CNS lesion radiotherapy, uncontrolled medical or psychiatric illness, major competing malignancy, or hypersensitivity…
04
Endpoints
Primary
2-year progression-free survival rate
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