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New treatment option for Central Nervous System Lymphoma
Official title Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT05260619
What this study is testing
What is lenalidomide?
lenalidomide is an investigational medicine, being studied as a potential treatment for central nervous system lymphoma.
Also referred to as Lenalid®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- PCNSL patients whose achieved response (CR/PR) after first line immunochemotherapy treatment
- histology confirmed to be PCNSL
- ECOG \< 3
- 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...
You likely can't join if
- Pregnant or breastfeeding females.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's...
- Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active...
- Patients with extra-central nervous system lymphoma
- Patients who were previously exposed and who developed adverse events, hypersensitivity or desquamating rash to lenalidomide
- prior cancer history
See the full eligibility criteria
- PCNSL patients whose achieved response (CR/PR) after first line immunochemotherapy treatment
- histology confirmed to be PCNSL
- ECOG \< 3
- 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...
- 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...
- 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.
- 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.
- Pregnant or breastfeeding females.
- 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...
- 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.
- Patients with extra-central nervous system lymphoma
- Patients who were previously exposed and who developed adverse events, hypersensitivity or desquamating rash to lenalidomide
- prior cancer history
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Please Select, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Please Select, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.