New drug combo aims to stop brain lymphoma from returning
NCT ID NCT04627753
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a two-year maintenance treatment with lenalidomide and rituximab can prevent relapse in patients with primary central nervous system lymphoma who have responded to initial chemotherapy but are not eligible for a stem cell transplant. The study will enroll 30 participants and track how long they live without the cancer progressing. The goal is to improve survival in a group that currently has very poor outcomes after relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenalidomide and rituximab (drugs)
- What this could lead to
- If successful, this maintenance therapy could help prevent relapse and extend survival for patients with primary CNS lymphoma who cannot undergo a stem cell transplant.
- What could go wrong
- This is a small, early-phase study (30 participants) with no control group. The drugs may cause side effects, and it is not yet known if they will meaningfully improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, 135710, South Korea
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