[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-lymphoproliferative-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-lymphoproliferative-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100555315","phase-2-epcoritamab-in-previously-treated-wm-100555315",false,"NCT06510491","Epcoritamab in Previously Treated WM","A Phase 2 Trial Investigating Epcoritamab in Patients With Previously Treated Waldenstrom Macroglobulinemia (WM)","Inclusion Criteria:\n\n* A diagnosis of lymphoplasmacytic lymphoma\u002FWM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy\u002Faspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted.\n* Serum IgM level \\>2x upper limit of normal (ULN)\n* Meeting criteria for initiation of treatment per IWWM2 criteria \\[Kyle Semin Oncol 2002\\], including but not limited to hyperviscosity syndrome, peripheral neuropathy, cold agglutinin disease, cryoglobulinemia, amyloidosis, cytopenias due to bone marrow infiltration, symptomatic or bulky lymph nodes, symptomatic splenomegaly, constitutional symptoms not otherwise explained by other causes, signs of organ dysfunction secondary to WM\n* At least one prior line of treatment that was discontinued either due to intolerance or disease progression\n* Prior therapies must have included an anti-CD20 antibody (e.g. rituximab) and a BTK inhibitor (e.g. ibrutinib, zanubrutinib). Patients who received ibrutinib and rituximab in combination as first line therapy will be eligible. BTKi should be stopped to allow a washout period of no less than 4 half-lives prior to epcoritamab.\n* Age ≥18 years\n* ECOG performance status £ 2\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1000 cells\u002Fmcl (G-CSF allowed)\n  * absolute lymphocyte count ≥200 cells\u002Fmcl\n  * platelets ≥75,000 cells\u002Fmcl OR ≥50,000 cells\u002Fmcl in the presence of bone marrow involvement or splenomegaly (Note: no PLT transfusions within 7 days prior to screening)\n  * hemoglobin ≥ 8 g\u002FdL (transfusion allowed)\n  * total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected\u002Fknown Gilbert's disease total bilirubin up to 3x ULN will be allowed but direct bilirubin must be ≤ 2 x ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * creatinine clearance \\>45 ml\u002Fmin (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)\n* Subject does not have an active (PCR-positive) Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. If laboratory evidence for a chronic infection with hepatitis B, close monitoring and prophylactic therapy is required as described in Section 5.4.\n* Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years before registration, the treatment was considered \"curable-intent\", and there is no evidence of disease.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:\n\n  * Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n  * Male partner sterilization (the vasectomized partner should be the sole partner for that patient)\n  * True abstinence (when this is in line with the preferred and usual lifestyle of the patient)\n* Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.\n* Patients with HIV may be enrolled if they are on stable antiretroviral therapy, have an undetectable viral load, and CD4 count \\> 250 cells\u002Fmm3.\n\nExclusion Criteria:\n\n* Participants who have disease that has transformed to aggressive lymphoma\n* Participants with symptomatic or suspected hyperviscosity syndrome or IgM levels greater than 4000 mg\u002FdL who are unable to undergo plasmapheresis to decrease the risk of an IgM flare. Participants who can undergo plasmapheresis will be eligible as long as they undergo the procedure prior to first treatment dose.\n* Participants who are receiving any other investigational agent\n* Washout from prior therapy: BTKi: no less than5 half-lives prior to epcoritamab to prevent BTKi rebound and rituximab: no less than 4 weeks (28 days) from last dose.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) except for alopecia and peripheral neuropathy\n* Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment\n* Uncontrolled underlying cardiac conditions including but not limited to: congestive heart failure grade III or IV (by NYHA) or EF \\\u003C 45%, unstable angina pectoris, acute myocardial infarction \\\u003C 6 months, uncontrolled cardiac arrhythmia\n* History of uncontrolled neurologic condition including but not limited to: seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis\n* Need for supplemental O2 at rest to maintain SaO2\\>92%\n* Chronic immunosuppressive therapy for non-WM-related indication within 28 days of initiation of treatment, including systemic corticosteroids 20 mg\u002Fday or greater prednisone-equivalent\n* Patients with known or suspected CNS involvement or leptomeningeal disease (i.e. BingNeel Syndrome) are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease\n* Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:\n\n  * Premenarchal\n  * Postmenopausal (\\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\>40 IU\u002FL or mIU\u002FmL)\n  * Permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Note: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.13.\n* Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab\n* Exposure to a live or a live attenuated vaccine within 4 weeks","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM).\n\nThe names of the study drug involved in this study is:\n\n-Epcoritamab (a type of antibody)",[26,27],"Waldenstrom Macroglobulinemia","B-Cell Lymphoproliferative Disorder",[26,27],"RECRUITING","2026-03-12",{"date":32,"type":33},"2026-03-13","ACTUAL",{"date":35,"type":33},"2024-12-06",{"date":37,"type":20},"2027-12-31",{"name":39,"class":40},"Gottfried von Keudell, MD PhD","OTHER",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100591880","phase-2-a-phase-2-study-to-evaluate-the-safety-and-efficacy-of-pacritinib-in-relapsed-or-refractory-waldenstrm-macroglobulinemia-100591880","NCT06986174","A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status ≤2\n* Clinicopathological diagnosis of Waldenström Macroglobulinemia\n* Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:\n\n  * constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss\n  * progressive or symptomatic lymphadenopathy or splenomegaly\n  * hemoglobin ≤10 g\u002FdL\n  * platelet count ≤100 k\u002FuL\n  * hyperviscosity syndrome\n  * symptomatic peripheral neuropathy\n  * systemic amyloidosis\n  * renal insufficiency\n  * symptomatic cryoglobulinemia\n* Serum IgM level ≥ 2 times the upper limit of normal\n* Participants must meet the following organ and marrow functions as defined below:\n\n  * absolute neutrophil count ≥0.5 k\u002FuL without growth factor within 7 days\n  * platelet count ≥50 k\u002FuL without platelet transfusion within 7 days\n  * total bilirubin ≤1.5 times the upper limit of normal or ≤3 times the upper limit of normal with documented liver involvement, hemolysis or Gilbert's disease\n  * AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal or ≤5 times the upper limit of normal with documented liver involvement\n  * Creatinine clearance ≥30 ml\u002Fmin using Cockcroft\u002FGault equation\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* At least 2 prior lines of treatment for Waldenström Macroglobulinemia. Participants must either be BTK inhibitor exposed or not be a candidate for BTK therapy.\n* Women of childbearing potential: Females of childbearing potential (FCBP) will be required to use two highly effective forms of contraception simultaneously or will remain abstinent from heterosexual intercourse during the following periods related to this study:\n\n  1. while participating in the study; and 2) for at least three months (90 days) after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.\n\nExclusion Criteria:\n\n* Current history of uncontrolled HIV\n* Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below\n\n  * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.\n  * Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.\n* Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)\n* Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)\n* Current CNS involvement by WM\n* Active alcohol or drug abuse\n* Concurrent administration of medications that are moderate or strong inhibitors or inducers of CYP3A within 14 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.\n* Concurrent participation in another therapeutic clinical trial\n* History of another malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, or other adequately treated cancer currently in complete remission\n* Prior or ongoing clinically significant illness, including active infections requiring antibiotics, of medical condition that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results\n* Inability to swallow pills\n* Significant cardiovascular disease defined as:\n\n  * Unstable angina, or\n  * History of myocardial infarction within 6 months prior to planned start\n  * Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during screening should be performed in selected patients as medically indicated, or\n  * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or\n  * Uncontrolled or symptomatic arrhythmias\n* Prolonged QT Interval with baseline QTc \\>480 msec using the Bazette formula\n* Ongoing, active infection.\n* Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.",{"count":49,"type":20},30,[23],"This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM).\n\nThe name of the study drug involved in this study is:\n\n-Pacritinib (a type of kinase inhibitor)",[53,54,27,55],"Waldenström Macroglobulinemia","Lymphoplasmacytic Lymphoma","Indolent Lymphoma",[53,54,57,27,55],"Lymphoma","2025-12-01",{"date":60,"type":33},"2025-12-05",{"date":62,"type":33},"2025-11-21",{"date":64,"type":20},"2032-10-01",{"name":66,"class":40},"Shayna Sarosiek, MD",1]