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New treatment option for Primary CNS Lymphoma
Official title Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.
ClinicalTrials.gov ID: NCT04627753
What this study is testing
What is Rituximab, lenalidomide?
Rituximab, lenalidomide is an investigational medicine, being studied as a potential treatment for primary cns lymphoma.
Also referred to as Truxima Inj, 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
- 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).
- 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
- Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for...
- 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
You likely can't join if
- 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...
- 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...
- . Known human immunodeficiency (HIV) seropositive
- Those who are unable to take oral medication
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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.
- 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...
- 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...
- . Known human immunodeficiency (HIV) seropositive
- Those who are unable to take oral medication
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, 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 Seoul, 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.