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New treatment option for Primary Central Nervous System Lymphoma
Official title Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
ClinicalTrials.gov ID: NCT05681195
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma.
Also referred to as Alimta.
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 study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival.
- 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 and older
You may be able to join if
- Any of the following diseases histologically confirmed:
- Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease
- Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease
- Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal...
- Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)
You likely can't join if
- Serious uncontrolled concurrent illness or comorbid condition
- Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer...
- Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
- Unable to comprehend the study requirements or who are not likely to comply with the study protocol
- Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment
- Pregnant (confirmed by serum or urine β-HCG) or lactating
See the full eligibility criteria
Who can join
- Any of the following diseases histologically confirmed:
- Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease
- Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease
- Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma.
- Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)
- Progressed during first-line chemotherapy and/or radiotherapy -OR- insufficient clinical response to previous therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as...
- No systemic lymphoma by positron emission tomography (PET) CT or CT scan of the chest, abdomen, and pelvis with contrast
- Adequate bone marrow and organ function demonstrated by:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
- Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 14 days prior to study enrollment
- Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 14 days prior to study enrollment
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
- Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome
- Creatinine Clearance (CrCl)\> 45 mL/minute using Cockcroft-Gault formula
- Ability to understand and sign written informed consent prior to study entry unless the subject suffers from cognitive or physical impairment due to their CNS malignancy or due to a known underlying medical condition in...
- Life expectancy of at least 2 months
- Females of childbearing potential must use highly effective method of contraception for the duration of the study and ≥ 30 days after the last dose of zanubrutinib. Female must also have a negative urine or serum...
- The investigator or a designated associate is requested to advise the patients how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine...
- Male patients with a female partner of childbearing potential are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment...
- Female patients of childbearing potential must practice highly effective methods of contraception.
- Male patients with female partners must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods. Acceptable contraception methods are included in the study protocol.
- Patients using hormonal contraceptives (e.g., birth control pills or devices) must use a barrier method of contraception (e.g., condoms) as well.
- For patients with Infectious disease, must have:
- HIV positive with negative viral load and CD4 count \> 400
- Non-viremic Hepatitis C Virus (HCV)
- HBcAb (Hepatitis B core positive) and HBsAg negative
What rules you out
- Serious uncontrolled concurrent illness or comorbid condition
- Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer under observation. Patients with a remote history (3 years or more) of...
- Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
- Unable to comprehend the study requirements or who are not likely to comply with the study protocol
- Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment
- Pregnant (confirmed by serum or urine β-HCG) or lactating
- Transaminases \> 3 times above the upper limits of the institutional normal
- Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment with the exception of dexamethasone, or low dose prednisone with a total dose equivalent to 15 mg of prednisone a day or less...
- Patients should not have active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura).
- Non-healing wound, ulcer or bone fracture
- Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia
- Cerebrovascular accident or intracranial hemorrhage within 6 months of the study treatment; arterial or venous thrombotic or embolic event such as deep vein thrombosis or pulmonary embolism within 3 months before the...
- Concurrent use of warfarin or other vitamin K antagonists (need to be stopped 7 days prior to starting on trial drug)
- Infectious disease: HIV positive patients with positive viral load and CD4+ count \< 400 are excluded. HIV patients must have established and consistent infectious disease specialist care. HIV positive patients have to...
- Patients with presence of HCV antibody are eligible if HCV RNA is undetectable and if they are willing to undergo monitoring for HCV reactivation every 12 weeks. HCV patients will be taken off trial if there is 1 log...
- Patients with detectable hepatitis B surface antigen (HBsAg) are excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, are eligible if HBV DNA is undetectable and if they are...
- Currently active, clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- New York Heart Association class III or IV congestive heart failure
- History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- Any uncontrolled active systemic infection or infection requiring systemic treatment that was completed ≤ 7 days before the first dose of therapy
- Participants who received a strong cytochrome P450 (CYP) 3A inhibitor or inducer within 7 days prior to the first dose of protocol anti-fungal prophylaxis, or participants who require continuous treatment with a strong...
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety, or put the study at undue risk. Participants with suspicious...
- Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma
- Vaccination with a live or attenuates vaccine within 28 days prior to the first dose of zanubrutinib. Live or attenuated vaccines are not allowed during treatment with zanubrutinib
- Hypersensitivity to zanubrutinib or pemetrexed or any of the other ingredients of the applicable study drug
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. 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.