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New treatment option for Primary Central Nervous System Lymphoma (PCNSL)
Official title A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
ClinicalTrials.gov ID: NCT07082868
What this study is testing
What is ibrutinib?
ibrutinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for primary central nervous system lymphoma (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
- The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).
- 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
- \>/= 18 years of age on the day of consenting to the study.
- Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
- Participants must have an ECOG performance status of 0, 1, or 2.
- Participants must have adequate bone marrow and organ function shown by:
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
You likely can't join if
- Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.
- Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Patient has an active concurrent malignancy requiring active therapy
- Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks...
- Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
See the full eligibility criteria
Who can join
- \>/= 18 years of age on the day of consenting to the study.
- Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
- Participants must have an ECOG performance status of 0, 1, or 2.
- Participants must have adequate bone marrow and organ function shown by:
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelets ≥ 75 x 109/L and no platelet transfusion within the past 21 days prior to study consent
- Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent
- International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)
- 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 (CLCr) ≥ 40 ml/min (based on the following formular Creatinine clearance= ((140-age)\ wt)/(creatinine\ 72); multiply by 0.85 for women)
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to...
- Female people of childbearing potential must have a negative serum pregnancy test upon study entry. See section on Pregnancy and Reproduction.
- Patients must be able to tolerate MRI/CT scans.
- Due to the nature of this disease, we will allow patients with impaired decision-making ability to enroll into all cohorts.
What rules you out
- Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.
- Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Patient has an active concurrent malignancy requiring active therapy
- Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the...
- Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
- Patient requires more than 8 mg of dexamethasone daily or the equivalent
- Patient is using warfarin or any other warfarin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low...
- Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to initiation of study therapy
- Patient is taking a drug known to be a moderate or strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least 5 half-lives or at least two weeks...
- Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \> 5 mg/day of prednisone or the equivalent (for more than...
- Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension...
- Patient has an ejection fraction of \<50%
- Patient has a known bleeding diathesis (e.g. von Willebrand's disease) or hemophilia.
- Patient is documented to have human immunodeficiency virus (HIV) infection.
- Patient is documented to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.
- Patient is known to have an uncontrolled active systemic infection.
- Patient is unable to swallow capsules or has a disease or condition significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel...
- Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
- Patient has not received vaccination with live vaccines within 28 days prior to first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the...
- Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of \> 5 mIU/mL...
- Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor...
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 4 months after study discontinuation. Highly...
- True abstinence: When this is the line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable...
- Sterilization: Surgical bilateral oophorectomy, with or without hysterectomy, or tubal ligation at least six weeks prior to study enrollment.
- Male partner sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients participating in the study, the vasectomized male partner should be the sole...
- Use of a combination of any two of the following:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal form/gel/film/cream/vaginal suppository
- Women of child-bearing potential must have one negative serum pregnancy tests at screening
- In addition to having a negative pregnancy test confirmed at screening, all female participants of child bearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study...
- Fertile males, defined as all male people physiologically capable of conceiving offspring, must use a condom during study treatment and for 12 months after study discontinuation and should not father a child in this...
- Female partner of a male study subject should use a highly effective method of contraception while the male partner is receiving the study agent and for 12 months after the final dose of the study therapy. Inclusion of...
- Ibrutinib and epcoritamab are not known to differentially affect subpopulations, including women, minorities, or other underrepresented groups. The eligibility and exclusion criteria are not expected to differentially...
- No signs/symptoms suggestive of active SARS-CoV-2 infection
- Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart Given the ongoing COVID-19 pandemic, selected non-live vaccines (e.g. mRNA, non-replicating viral vector, protein subunit...
- The first dose of study drug, when possible, is preferred to be given at least 14 days from SARS-CoV-2 vaccine administration.
- A minimum period of 3 days must occur between the administration of an appropriate COVID-19 vaccine and the administration od epcoritamab (to avoid overlapping AEs). Note: The above guidance applies to all SARS-CoV-2...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Salt Lake City, Utah, 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 Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.