Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Primary Central Nervous System Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Lenalidomide

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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.

Rituximab, lenalidomide

Seok Jin Kim, MD, PhD

Won Seog Kim, MD PhD

Won Seog Kim, MD, PhD

* 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).

-As described, standard treatment for patients with primary central nervous system lymphoma is not yet based on a high level of evidence, and studies on consolidation therapy for elderly patients who cannot transplant this disease are very limited. Based on the Korea National Cancer Incidence Database, about 100 to 150 cases of primary central nervous system lymphoma are diagnosed per year in Korea, and 15 to 30% of them are judged to experience recurrence.

Rituximab and lenalidomide (RR) are drugs that are expected to play a role in patients with primary central nervous system lymphoma who have already refractory or relapsed as described above, but there is a big hurdle that the number of patients is limited. Since then, it has not been studied as consolidation therapy in elderly or non-transplantable patients. Therefore, the present investigators attempted to confirm the efficacy and safety of lenalidomide/rituximab maintenance therapy in patients with primary central nervous system lymphoma who received high-dose methotrexate-containing anticancer drug, but could not receive consolidation therapy with autograft.

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

Phase II Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)

The incidence of tumor progression or death from all causes during the 1-year follow-up period from the first drug administration date.

The incidence of tumor progression or death from all causes during the 2-year follow-up period from the first drug administration date.

The time from the first drug administration to death from any cause.

The proportion of patients who achieve complete and partial response.

Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v4.03. Adverse events not reported in NCIC CTG will be categorized into mild, moderate, severe, and fatal and further classified to CTCAE Grades 1-4.

Celltrion

Samyang Biopharmaceuticals Corporation

Kim, Seok Jin

MD, PhD, Division of hematology-oncology, Department of medicine

Spots Global Cancer Trial Database for rituximab, lenalidomide