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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL. (NCT04627753) is a Phase 2 interventional studying Primary CNS Lymphoma, sponsored by Kim, Seok Jin. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

* 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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Primary CNS Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response. 2. Those who are unable to transplant autologous hematopoietic stem cells for the following reasons - If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy - Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy 3. Adequate laboratory functional values - Absolute neutrophil count ≥ 1000/ul - Platelet count ≥ 50,000/ul - blood count (hemoglobin) at least 9.0 g/dL - Serum calcium ≤ 12.0mg/dL - Serum creatinine ≤ 1.5 X UNL - AST/ALT ≤ 2.5 X UNL - Total bilirubin ≤ 1.5 X UNL 4. Hepatitis B patients with combination of prophylactic antiviral therapy 5. ECOG PS 0-2 6. Those who can take oral medication 7. Written willing to sign a consent form under institutional guidelines. 8. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide. 9. Effective method of contraception should be used during and for 28 days following the last dose of the drug \- FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response. 2. Those who are unable to transplant autologous hematopoietic stem cells for the following reasons * If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy * Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy 3. Adequate laboratory functional values * Absolute neutrophil count ≥ 1000/ul * Platelet count ≥ 50,000/ul * Hemoglobin ≥ 9.0 g/dL * Serum calcium ≤ 12.0mg/dL * Serum creatinine ≤ 1.5 X UNL * AST/ALT ≤ 2.5 X UNL * Total bilirubin ≤ 1.5 X UNL 4. Hepatitis B patients with combination of prophylactic antiviral therapy 5. ECOG PS 0-2 6. Those who can take oral medication 7. Written informed consent under institutional guidelines. 8. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide. 9. Effective method of contraception should be used during and for 28 days following the last dose of the drug \- FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 10. Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP. Exclusion Criteria: 1. If autotransplantation is planned after chemotherapy 2. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle. 3. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents. 4. Uncontrolled hepatitis C infection and/or hepatitis B (except for patients with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed). 5. . Known human immunodeficiency (HIV) seropositive 6. Those who are unable to take oral medication 7. Patients with a history of malignant tumors other than the target diseases except for the following cases * If the tumor has not been treated for at least 5 years or is disease-free * Patients at least 1 year after complete resection of basal cell carcinoma / squamous cell carcinoma or successful treatment of cervical epithelial cancer 8. Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria 9. Occurrence of blood clots or embolism within 6 months before starting screening 10. Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.) 11. Patients with seizure disorder requiring medication 12. Female patients who are pregnant or lactating. 13. Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. 14. Patients with hyperreactivity to rituximab.

Treatments Being Tested

DRUG

Rituximab, lenalidomide

Maintenance for 2 years

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Samsung Medical Center
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04627753), the sponsor (Kim, Seok Jin), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04627753 clinical trial studying?

* 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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04627753?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04627753?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04627753. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04627753. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.