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
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.
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.
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.
Browse Lymphoma studies →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.
Hematology values must be within the following limits:
Absolute neutrophil count (ANC) ≥ 1000/µl Platelets ≥75,000/µl
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.
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).
Exclusion Criteria:
lenalidomide will be given as maintenance treatment to 28 PCNSL patients after achieving response to high-dose methotrexate-based immunochemotherapy
Drug: lenalidomide
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®
PFS
progression-free survival
Time frame: 2-year
ORR
Overall response rate
Time frame: 2-year
OS
Overall survival
Time frame: 2-year
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Bundang Hospital