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RecruitingNCT05260619PCNSL-LEMUpdated Mar 2, 2022

Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma

A Phase 2 interventional study of lenalidomide in Central Nervous System Lymphoma, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Seoul National University Bundang Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

The study will include 28 patients with primary CNS DLBCL who are ineligible with autologous hematopoietic stem cell transplantation or whole brain radiation therapy as consolidation therapy.

Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent).

Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, withdrew consent, the disease progressed, or unacceptable toxic effects occurred.

Read the detailed description

The study will include 28 patients with primary CNS DLBCL who are ineligible with autologous hematopoietic stem cell transplantation or whole brain radiation therapy as consolidation therapy.

Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent).

Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for up to 12 cycles or until the patients withdrew consent, the disease progressed, or unacceptable toxic effects occurred.

Maintenance therapy has to be started 6 weeks after the last dose of induction chemotherapy. Response evaluation by brain MRI has to be checked every 3 months after starting maintenance therapy.

02

Conditions studied

  • Central Nervous System Lymphoma

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03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 28 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

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Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. PCNSL patients whose achieved response (CR/PR) after first line immunochemotherapy treatment
  2. histology confirmed to be PCNSL
  3. ECOG \< 3
  4. Hematology values must be within the following limits:

    Absolute neutrophil count (ANC) ≥ 1000/µl Platelets ≥75,000/µl

  5. Biochemical values within the following limits:

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) Total bilirubin ≤ 2.0 x ULN Creatinine clearance (CrCl) of greater than or equal to 30 mL/min.

  6. Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide.

    *A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).

  7. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy.
  8. Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding females.
  2. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
  3. Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
  4. Patients with extra-central nervous system lymphoma
  5. Patients who were previously exposed and who developed adverse events, hypersensitivity or desquamating rash to lenalidomide
  6. prior cancer history
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Single arm

    lenalidomide will be given as maintenance treatment to 28 PCNSL patients after achieving response to high-dose methotrexate-based immunochemotherapy

    Drug: lenalidomide

Interventions

  • Druglenalidomide

    Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for up to 12 cycles or until the patients withdrew consent, the disease progressed, or unacceptable toxic effects occurred.

    Also known as: Lenalid®

06

What researchers measure

Primary outcomes

  1. PFS

    progression-free survival

    Time frame: 2-year

Secondary outcomes

  1. ORR

    Overall response rate

    Time frame: 2-year

  2. OS

    Overall survival

    Time frame: 2-year

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Please Select 13620, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05260619
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
Samyang BioPharm
Responsible party
Sponsor
First posted
Mar 2, 2022
Start date
Apr 1, 2022 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Mar 2, 2022

Study contacts

Jeong-Ok S Lee
Contact
jeongok77@gmail.com
+82317878226

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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