Actively Recruiting
Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma
Led by Seoul National University Bundang Hospital · Updated on 2022-03-02
28
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
S
Samyang BioPharm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary central nervous system lymphoma confirmed by histology
- Achieved complete or partial response after first-line immunochemotherapy
- ECOG performance status less than 3
- Absolute neutrophil count (ANC) of at least 1000/µl
- Platelet count of at least 75,000/µl
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 2.5 times the upper limit of normal
- Total bilirubin no more than 2.0 times the upper limit of normal
- Creatinine clearance of at least 30 mL/min
- Females of childbearing potential must have negative pregnancy tests within 10-14 days and again within 24 hours before starting lenalidomide
- Females of childbearing potential must agree to abstain or use two forms of birth control starting at least 28 days before lenalidomide
- Male participants must agree to use a latex condom during sexual contact with females of childbearing potential
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding females
- Any life-threatening illness, medical condition, or organ dysfunction that may compromise safety or study outcomes
- Known HIV infection or active hepatitis B or C infections
- Any uncontrolled active systemic infection requiring intravenous antibiotics
- Presence of lymphoma outside the central nervous system
- Prior exposure to lenalidomide with adverse reactions such as hypersensitivity or rash
- History of prior cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Please Select, South Korea, 13620
Actively Recruiting
Research Team
J
Jeong-Ok S Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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