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Primary CNS LymphomaPhase 2Lemon-CNCT04627753

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

A Phase 2 study testing Rituximab, lenalidomide in people with Primary CNS Lymphoma, run by Kim, Seok Jin at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Primary CNS Lymphoma
What is being tested?
Rituximab, lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
2 Nov 2020to 2 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
  • Adequate laboratory functional values
  • Absolute neutrophil count ≥ 1000/ul
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  • 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
  • Hepatitis B patients with combination of prophylactic antiviral therapy
  • ECOG PS 0-2
  • Those who can take oral medication
  • Written informed consent under institutional guidelines.
  • 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.
  • 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).
  • 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.

Who cannot join

  • If autotransplantation is planned after chemotherapy
  • 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.
  • Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents.
  • 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).
  • . Known human immunodeficiency (HIV) seropositive
  • Those who are unable to take oral medication
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  • 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
  • Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria
  • Occurrence of blood clots or embolism within 6 months before starting screening
  • Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.)
  • Patients with seizure disorder requiring medication
  • Female patients who are pregnant or lactating.
  • Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.
  • Patients with hyperreactivity to rituximab.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seok Jin Kim, MD, PhD contact

82-2-3410-1766

kstwoh@skku.edu

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 135710

    Won Seog Kim, MD PhD, 82234106548, wskimsmc@skku.edu

    Won Seog Kim, MD, PhD

    Recruiting

Other trials in South Korea

About this study

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

  • 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).
Read the detailed description

-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.

Being tested
Rituximab, lenalidomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab, lenalidomideDrug

    Also called Truxima Inj, Lenalid

    Maintenance for 2 years

Study groups in NCT04627753
Study groupRoleWhat they receive
Lenalidomide and Rituximab therapyExperimentalThe 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.
Receives: Drug: Rituximab, lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year progression free survival

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

    Measured: 12 months

Secondary outcomes (4)

  1. 2-year progression free survival

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

    Measured: 24 months

  2. Overall survival

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

    Measured: 24 months

  3. Overall response

    The proportion of patients who achieve complete and partial response.

    Measured: 24 months

  4. Toxicity profiles

    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.

    Measured: from the date of informed consent signature to 30 days after last drug administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start2 Nov 2020
  3. Primary completion2 Nov 2028 (estimated)
  4. Study completion2 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627753
Sponsor's protocol ID
2019-10-081
Acronym
Lemon-C
Status last verified
Apr 2026
First submitted
8 Nov 2020
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, lenalidomide in people with Primary CNS Lymphoma, run by Kim, Seok Jin at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seok Jin Kim, MD, PhD (82-2-3410-1766, kstwoh@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year progression free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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