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New treatment option for CNS Lymphoma
Official title Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
ClinicalTrials.gov ID: NCT06730542
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cns lymphoma.
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 purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.
- Phase 1: an early, usually small safety study
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
- Men and women ≥ 18 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study...
- Patients must have histologic confirmation of large B-cell lymphoma (LBCL) defined by the World Health Organization (WHO) classification. All LBCL...
- Baseline 18-fluorodeoxyglucose (FDG)-positron emission tomography scan/computed tomography (PET/CT) must demonstrate FDG avid lesions compatible with...
- Presence of systemic and CNS involvement (brain, cerebellum, brainstem, meninges, cranial nerves, eyes, spinal cord, or a combination of these) at...
- Determination of CNS involvement can be by brain biopsy, cerebrospinal fluid (CSF) evaluation by cytology and/or flow cytometry, neuroimaging, or...
You likely can't join if
- Primary CNS lymphoma without evidence of systemic lymphoma.
- Prior systemic lymphoma therapy (Note: 1 cycle of an anthracycline based regimen, such as rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin...
- Any uncontrolled or 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;
See the full eligibility criteria
Who can join
- Men and women ≥ 18 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Patients must have histologic confirmation of large B-cell lymphoma (LBCL) defined by the World Health Organization (WHO) classification. All LBCL subtypes are acceptable. Note: Patients with prior treatment for...
- Baseline 18-fluorodeoxyglucose (FDG)-positron emission tomography scan/computed tomography (PET/CT) must demonstrate FDG avid lesions compatible with CT-defined anatomical tumor sites (Note: FDG-PET/CT is not mandatory...
- Presence of systemic and CNS involvement (brain, cerebellum, brainstem, meninges, cranial nerves, eyes, spinal cord, or a combination of these) at presentation.
- Determination of CNS involvement can be by brain biopsy, cerebrospinal fluid (CSF) evaluation by cytology and/or flow cytometry, neuroimaging, or strong clinical suspicion by Investigator for which CNS targeted therapy...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2, except due to lymphoma involvement.
- Life expectancy of greater than ≥ 3 months.
- Women should avoid becoming pregnant while taking zanubrutinib and for up to 90 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking...
- Female patients of childbearing potential must use highly effective methods of contraception. Recommended acceptable contraception methods are included in Section 5.12.
- Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.
- A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral...
- A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.
- Male patients with a female partner of childbearing potential are eligible if they abstained, are vasectomized or if they agree to the use of barrier contraception with other methods described above during the study...
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) \> 1,000 cells/mm3 independent of growth factor support within 7 days of study entry (≥ 750 cells/mm3 if lymphoma involvement of the bone marrow or spleen).
- Platelets ≥ 75,000 platelets/mm3 independent of transfusion support within 7 days of study entry (≥ 50,000/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone marrow...
- Hemoglobin \> 9 g/dL or \> 8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.
- Serum total bilirubin ≤ 2 x upper limit of normal (ULN; except patients with Gilberts syndrome).
- Aspartate aminotransferase (AST; serum glutamic-oxaloacetic transaminase (SGOT)) and alanine transaminase (ALT); serum glutamic-pyruvic transaminase (SGPT)) ≤2.5 x institutional ULN (≤3x institutional ULN if lymphoma...
- Creatinine within normal institutional limits, or creatinine clearance ≥ 40 mL/min (as estimated by the Cockcroft-Gault equation or alternative formula according to institutional guidelines) for patients with creatinine...
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments (SoA).
What rules you out
- Primary CNS lymphoma without evidence of systemic lymphoma.
- Prior systemic lymphoma therapy (Note: 1 cycle of an anthracycline based regimen, such as rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone (R-CHOP), polatuzumab vedotin, rituximab...
- Any uncontrolled or 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 (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- Uncontrolled hypertension as indicated by ≥ 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mm Hg and/or diastolic blood pressure \> 105 mm Hg at screening.
- QT interval corrected with Fridericia's formula (QTcF) \> 450 msec or other significant electrocardiogram (EKG) abnormalities, including second-degree atrioventricular block Type II or third-degree atrioventricular...
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Uncontrolled intercurrent illness such as liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (\> 10 mg daily prednisone equivalent), or any other serious medical condition...
- Severe or debilitating pulmonary disease.
- Concurrent malignancy requiring active therapy.
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6...
- Active fungal, bacterial and/or viral infection requiring systemic therapy.
- Breastfeeding or pregnant women.
- Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
- Patients with positive HIV test and undetectable viral load will be eligible for this study.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\< 20 IU), and if...
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable. For more information regarding hepatitis B and C testing, please refer to Section 9.2.5.4.
- Patients with impaired decision-making capacity.
- Ongoing treatment with medications that are strong cytochrome P450 (CYP), family 3, subfamily A (CYP3A) inducers.
- Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, stomach or small bowel resection, bariatric surgery procedures, symptomatic inflammatory bowel...
- History of severe bleeding disorder, such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- History of stroke or intracranial hemorrhage within 180 days before the first dose of zanubrutinib.
- Major surgery within 4 weeks of the first dose of zanubrutinib. Major surgery is defined as open-heart, reconstructive, transplant, removal of a brain tumor or a damaged kidney surgery.
- The patient requires treatment with warfarin, warfarin derivatives, or other vitamin K antagonists.
- Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.
- Hypersensitivity to zanubrutinib, any components of pola-R-CHP, regimen, and/or high-dose (HD) methotrexate (MTX), or any of the other ingredients of the applicable study medications.
- Concurrent participation in another therapeutic clinical trial.
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.