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New treatment option for PCNSL
Official title A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT06554561
What this study is testing
What is Pomalidomide?
Pomalidomide is an investigational medicine, being studied as a potential treatment for pcnsl.
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
- This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d.
- 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 18 to 75
You may be able to join if
- Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
- The lesions were confined to the central nervous system, including the brain, spinal cord, eyes and meninges.
- Through physical examination, imaging examination (including CT, MRI, PET-CT, etc.) and bone marrow puncture examination, it was confirmed that no...
- Patients who have not previously received chemotherapy or radiotherapy (except those with dexamethasone less than 10mg/ day (or equivalent dose) and...
- Aged between 18 and 75 (inclusive).
You likely can't join if
- Have systemic lymphoma disease.
- Previous systemic or local treatment such as chemotherapy and/or radiotherapy and/or hematopoietic stem cell transplantation.
- Previous or concurrent history of other malignant tumors requiring active therapy.
- Chronic or currently active infectious diseases requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV infections).
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, bleeding diseases, thrombotic diseases, connective tissue diseases and other...
- Patients with other uncontrolled diseases that the researchers deemed unsuitable for inclusion.
See the full eligibility criteria
- Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
- The lesions were confined to the central nervous system, including the brain, spinal cord, eyes and meninges.
- Through physical examination, imaging examination (including CT, MRI, PET-CT, etc.) and bone marrow puncture examination, it was confirmed that no parts other than the central nervous system were involved.
- Patients who have not previously received chemotherapy or radiotherapy (except those with dexamethasone less than 10mg/ day (or equivalent dose) and duration less than 5 days).
- Aged between 18 and 75 (inclusive).
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
- Participants must be able to understand and be willing to sign a written informed consent document.
- Participants can follow up on schedule, communicate well with the investigator and complete the trial according to the trial regulations.
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to...
- Have systemic lymphoma disease.
- Previous systemic or local treatment such as chemotherapy and/or radiotherapy and/or hematopoietic stem cell transplantation.
- Previous or concurrent history of other malignant tumors requiring active therapy.
- Chronic or currently active infectious diseases requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV infections).
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, bleeding diseases, thrombotic diseases, connective tissue diseases and other diseases.
- Patients with other uncontrolled diseases that the researchers deemed unsuitable for inclusion.
- Laboratory test values at screening (unless due to lymphoma) : White blood cell count \< 3.5×109/L, neutrophils \<1.5×109/L, platelets \<80×109/L, hemoglobin \<100g/L, ALT or AST 2.5 times higher than the upper limit of...
- Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV. HbsAg positive...
- Pregnant or lactating women.
- Those with a history of drug use or abuse were asked.
- Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol.
- Known allergy to the investigational drug or its related ingredients.
- Patients are unable to swallow capsules or suffer from diseases or conditions that severely affect gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, or complete...
- Patients who cannot withstand enhanced MRI.
- Participants considered unsuitable for this clinical trial due to various other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, Zhejiang, China
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhou, Zhejiang, China. 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.