Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

Sponsor
Kim, Seok Jin
Study ID
NCT04627753
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary CNS Lymphoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).

Key Dates

Start date
Nov 2, 2020
Status verified
Apr 2026
Primary completion
Nov 2, 2028
Completion
Nov 2, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide and Rituximab therapy
    The clinical trial drug is administered in one cycle for 28 days and is administered as follows. Drug : Rituximab It will be administered 375 mg/m² IV infusion Day 1. (Rituximab: up to 6 cycles) Drug : Lenalidomide It will be administred 20 mg PO day 1 -21. The medication is taken for up to 2 years, and if there is no recurrence, it is stopped after 2 years , Or stop when disease progression is confirmed during the administration period.

Primary Outcome Measure

1 year progression free survival [ Time Frame: 12 months ]

Central Contacts