Actively Recruiting
Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.
Led by Kim, Seok Jin · Updated on 2026-04-23
30
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
K
Kim, Seok Jin
Lead Sponsor
C
Celltrion
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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).
CONDITIONS
Official Title
Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary central nervous system lymphoma confirmed by tissue pathology
- Completed standard induction chemotherapy and achieved complete or partial remission
- Unable to receive autologous hematopoietic stem cell transplantation due to age 65 or older, poor health status, or refusal
- Adequate blood counts and organ function (including neutrophils, platelets, hemoglobin, calcium, creatinine, liver enzymes, and bilirubin)
- Patients with hepatitis B on effective antiviral therapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Able to take oral medications
- Provided written informed consent
- Female patients of child-bearing potential must have two negative pregnancy tests before starting lenalidomide
- Use effective contraception during treatment and for 28 days after the last dose
- Male patients must use effective barrier contraception if sexually active with women of child-bearing potential during treatment and for 28 days after last dose
You will not qualify if you...
- Planned autologous stem cell transplantation after chemotherapy
- Active severe heart failure, recent heart attack, or uncontrolled heart conditions
- Active infections requiring systemic antibiotic, antiviral (except hepatitis B), or antifungal treatment
- Uncontrolled hepatitis B or C infection (except controlled hepatitis B on therapy)
- Known HIV infection
- Unable to take oral medications
- History of other cancers unless disease-free for at least 5 years or specific treated skin and cervical cancers
- Severe gastrointestinal bleeding within 30 days before screening
- Blood clots or embolism within 6 months before screening
- Allergic reactions to study drugs or their components
- Seizure disorders requiring medication
- Pregnant or breastfeeding women
- Genetic disorders affecting sugar metabolism
- Allergy or hypersensitivity to rituximab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 135710
Actively Recruiting
Research Team
S
Seok Jin Kim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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