[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Academic and Community Cancer Research United\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":141},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,71,94,118],{"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":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100452181","phase-2-atezolizumab-in-combination-with-a-multi-kinase-inhibitor-for-the-treatment-of-unresectable-locally-advanced-or-metastatic-liver-cancer-100452181",false,"NCT05168163","Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer","A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab","Inclusion Criteria:\n\n* Provide written informed consent =\\\u003C 28 days prior to randomization\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\n  * NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up\n* Age \\>= 18 years\n* Hepatocellular carcinoma (HCC) confirmed by histological\u002Fcytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria\n* Locally advanced, metastatic and\u002For unresectable disease that is not amendable to curative treatment\n* Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease\n\n  * NOTE: 2nd line patients only\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Child Pugh class A\n* Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) serology tests.\n\n  * For subjects with active HBV, HBV deoxyribonucleic acid (DNA) \\\u003C 500 IU\u002FmL obtained ≤ =\\\u003C 28 days prior to randomization, and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue treatment for the length of the study\n* At least one measurable untreated malignant lesion per RECIST v1.1. Subjects who previously received local therapy (e.g., ablation, percutaneous ethanol injection, trans-arterial embolization\u002Fchemo-embolization) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1\n* Consent to using archival tumor tissues, if available\n\n  * NOTE: Non-availability of tumor tissue does not exclude the subject.\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research for the first 10 patients per arm (Mayo Clinic Rochester and Mayo Clinic Arizona ONLY)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (1500\u002FuL) without granulocyte colony-stimulating factor support (obtained =\\\u003C 28 days prior to randomization)\n* Lymphocyte count \\>= 0.5 x 10\\^9\u002FL (500\u002FuL) (obtained =\\\u003C 28 days prior to randomization)\n* Platelet count \\>= 75 x 10\\^9\u002FL (75,000\u002FuL) (obtained =\\\u003C 28 days prior to randomization)\n* Hemoglobin \\>= 90 g\u002FL (9 g\u002FdL) (obtained =\\\u003C 28 days prior to randomization)\n\n  * Subjects may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\\\u003C 5 x upper limit of normal (ULN) (obtained =\\\u003C 28 days prior to randomization)\n* Total bilirubin =\\\u003C 3 x ULN (obtained =\\\u003C 28 days prior to randomization)\n* Serum albumin \\>= 30 g\u002FL (3.0 g\u002FdL) (obtained =\\\u003C 28 days prior to randomization)\n* For subjects not receiving therapeutic anticoagulation: international normalized ratio (INR) or partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN (obtained =\\\u003C 28 days prior to randomization)\n* Serum creatinine =\\\u003C 2 x ULN or creatinine clearance \\>= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula) (obtained =\\\u003C 28 days prior to randomization)\n* Negative pregnancy test done =\\\u003C 14 days prior to randomization, for women of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to grade =\\\u003C 1 prior to randomization, with the exception of alopecia and peripheral sensory neuropathy.\n* Subjects of childbearing potential agree to use two forms of medically approved contraception while taking the study drug and for at least 5 months after the last dose of atezolizumab or multi-kinase inhibitor. Subjects with partners of childbearing potential agree to use condoms, even after vasectomy, to avoid potential drug exposure to partner during study drug and for 5 months following the last dose of study drug\n* Ability to take oral medications\n\nExclusion Criteria:\n\n* Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma\n* Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)\n\n  * NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed \\>= 6 months prior to randomization\n* Any of the following prior therapies:\n\n  * Major surgery =\\\u003C 4 weeks prior to randomization; Minor surgery =\\\u003C 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines\u002FMediport). Subjects with clinically relevant complications from prior surgery are not eligible\n  * Any anti-cancer agent =\\\u003C 2 weeks prior to randomization\n  * Radiation therapy =\\\u003C 4 weeks (1 week for palliative radiation for bone metastases and\u002For for pain control) or radionuclide treatment (e.g., I-131 or Y-90) =\\\u003C 6 weeks prior to randomization\n* Treatment with investigational therapy =\\\u003C 28 days prior to randomization\n* Known brain or leptomeningeal metastasis\n* Known co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) will be considered non-infected with HCV\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:\n\n  * Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study\n  * Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n  * NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the subject at high risk from treatment complication\n* Treatment with a live, attenuated vaccine =\\\u003C 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or =\\\u003C 5 months after the last dose of atezolizumab\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Subjects with untreated or incompletely treated esophageal\u002Fgastric varices with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to local institutional standards) without any episodes of recurrent gastrointestinal bleeding requiring transfusion or hospitalization for \\> 28 days prior to randomization are eligible\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) =\\\u003C 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to randomization\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n\n  * Note: Prior treatment with atezolizumab is permitted\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF alpha agents) =\\\u003C 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n  * Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible\n* For subjects who are to receive cabozantinib: Treatment with strong inducers and\u002For strong inhibitors of CYP3A4 =\\\u003C 14 days prior to randomization, including rifampin (and its analogues) or St. John's wort. See https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers for lists of known strong inhibitors and strong inducers of CYP3A4\n* Active tuberculosis\n* Other uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including:\n\n    * Symptomatic congestive heart failure, unstable angina, or serious cardiac arrythmias\n    * Uncontrolled hypertensions defined as sustained blood pressure (BP) \\> 150 mmHg systolic BP, or \\> 100 mmHg diastolic BP despite optimal antihypertensive treatment\n    * Stroke (including transient ischemic attack), myocardial infarction, or other ischemic event =\\\u003C 3 months prior to randomization.\n    * Unstable arrythmia\n    * Thromboembolic event =\\\u003C 3 months prior to randomization. Subjects with thromboses of portal\u002Fhepatic vasculature attributed to underlying liver disease and\u002For liver tumor are eligible.\n  * Active bacterial infection requiring systemic treatment. Subjects on prophylactic antibiotics are eligible.\n  * Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) related illness. Subjects with known HIV but without clinical evidence of an immunocompromised state and receiving anti-retroviral therapy are eligible\n  * Prior allogenic stem cell or solid organ transplantation\n  * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n    * Subjects with indwelling catheters (e.g., PleurX) are allowed.\n  * Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n  * Uncontrolled tumor-related pain\n\n    * Patients requiring pain medication must be on a stable regimen at the time of randomization\n    * Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.\n    * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization\n* Other malignancy(ies) =\\\u003C 5 years prior to randomization except adequately treated non-melanotic skin cancer, carcinoma-in-situ of the cervix, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of study medication\n* Uncontrolled hepatic encephalopathy occurring =\\\u003C 6 weeks prior to randomization NOTE: Patients with =\\\u003C grade 2 encephalopathy =\\\u003C 6 weeks prior to randomization are eligible and supportive measures such as lactulose and antibiotics are allowed","ALL","18 Years",{"count":19,"type":20},122,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.",[26,27,28,29,30,31,32,33,34],"Locally Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Unresectable Hepatocellular Carcinoma","RECRUITING","2025-09-10",{"date":38,"type":39},"2025-09-16","ACTUAL",{"date":41,"type":39},"2022-05-27",{"date":43,"type":20},"2026-12-31",{"name":45,"class":46},"Academic and Community Cancer Research United","OTHER",16,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100528395","phase-2-retifanlimab-with-bevacizumab-and-hypofractionated-radiotherapy-for-the-treatment-of-recurrent-glioblastoma-100528395","NCT06160206","Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma","A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Recurrent World Health Organization (WHO) grade IV glioblastoma. Note: Any number of recurrences are allowable. Glioblastoma (GBM) variants and molecular GBM are allowed\n* Candidates for radiotherapy\n* Prior use of bevacizumab is allowed as long as the last treatment is \\> 4 months prior to randomization\n* Dexamethasone dose ≤ 4mg daily at the time of randomization (higher dose of steroid for symptom control is allowed during the study)\n* Karnofsky performance status ≥ 60%\n* Measurable disease or non-measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the Academic and Community Cancer Research Untied (ACCRU) website under \"General Forms\"\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Creatinine ≤ 1.5 x ULN (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Negative pregnancy test done ≤ 14 days prior to registration for women of childbearing potential only. (Pregnancy test can be urine or serum.)\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * A female of childbearing potential is a sexually mature female who:\n\n    * 1\\) Has not undergone a hysterectomy or bilateral hysterectomy; or\n    * 2\\) Has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)\n* Provide informed written consent ≤ 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment)\n* Willing to provide mandatory blood specimens for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)\n* Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any other investigational agent which would be considered treatment for the primary neoplasm ≤ 2 weeks prior to registration\n* Active uncontrolled autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, active inflammatory bowel disease) that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Has a severe acute or chronic medical condition including immune colitis, inflammatory bowel disease (may be enrolled at the discretion of the principal investigator \\[PI\\]), immune pneumonitis, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to epacadostat, retifanlimab, bevacizumab, or other agents used in the study\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* Has uncontrolled human immunodeficiency virus (HIV) (HIV ½ antibodies). Well-controlled HIV is defined as CD4+ count \\> 300 cells, undetectable viral load, and receiving highly active antiretroviral therapy (HAART)\u002Fantiretroviral therapy (ART). Study specific HIV testing is not required for patients who do not have any prior history of HIV\n* Has uncontrolled active hepatitis B (HBV) (e.g., hepatitis B serum antigen \\[HBsAg\\] reactive or HBV dioxyribonucleic acid \\[DNA\\] detected by quant real time polymerase chain reaction \\[RT PCR\\]) or hepatitis C (e.g. hepatitis C serum antigen \\[HCsAg\\] reactive or hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative or quantitative\\] is detected)\n* Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed",{"count":56,"type":20},134,[23],"This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.",[60,61],"Recurrent Glioblastoma","Recurrent WHO Grade 4 Glioma","2024-11-14",{"date":64,"type":39},"2024-11-19",{"date":66,"type":39},"2024-10-02",{"date":68,"type":20},"2030-11-30",{"name":45,"class":46},3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100509236","phase-2-tafasitamab-lenalidomide-and-venetoclax-for-the-treatment-of-relapsed-or-refractory-mantle-cell-lymphoma-100509236","NCT05910801","Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma","Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): a Phase II Study with Safety Lead-In","V-MIND","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Confirmed pathology diagnosis of mantle cell lymphoma (MCL) with t(11;14)(q13;q32) translocation or cyclin D1 overexpression NOTE: Patients with relapsed\u002Frefractory MCL after prior anti-CD19 therapy (such as chimeric antigen receptor \\[CAR\\] T-cell therapy) should have confirmed preserved expression of CD19, unless a biopsy is not feasible or associated with a high risk of complications in the treating physician's opinion\n* Relapsed or refractory disease, which is defined as patients with \\>= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or venetoclax is allowed, provided there was no disease progression on lenalidomide or venetoclax\n* In the view of the treating physician, the patient is in need of treatment, for example, with lymphoma-related symptoms or cytopenia\n* Evaluable disease, which is defined as at least one lymph node or other type of lesion that has a size \\>= 1.5 cm, or spleen size \\>= 15 cm or white blood cell (WBC) \\>= 30,000\u002Fmm\\^3 in leukemic non-nodal MCL patients\n* Eastern Cooperative Oncology Group Performance Status (PS) 0, 1, or 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to registration)\n* Platelet count \\>= 75,000\u002Fmm\\^3 (\\>= 50,000\u002Fmm\\^3 if there is evidence of bone marrow involvement by MCL or hypersplenism) (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\> 8.0 g\u002FdL (obtained =\\\u003C 14 days prior to registration)\n* Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =\\\u003C 1.5 × upper normal limit (ULN) (obtained =\\\u003C 14 days prior to registration)\n* Prothrombin (PT) or international normalized ratio (INR) =\\\u003C 1.5 × upper normal limit (ULN) (obtained =\\\u003C 14 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 × ULN (or =\\\u003C 3 × ULN if there is evidence of parenchymal liver involvement with MCL or documented Gilbert's disease) (obtained =\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 × ULN (or =\\\u003C 5 × ULN if there is evidence of parenchymal liver involvement with MCL) (obtained =\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance \\> 60 ml\u002Fmin using the Cockcroft-Gault formula (obtained =\\\u003C 14 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for women of reproductive potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required NOTE: Females of reproductive potential include all females who are menstruating, amenorrheic from previous medical treatments, under 50 years of age, and\u002For perimenopausal, and do not qualify for the females not of reproductive potential category. Females not of reproductive potential include females who have been in natural menopause for at least 24 consecutive months, or who have had a hysterectomy and\u002For bilateral oophorectomy, or female children who have not started menstruating\n* Agree to use effective contraception during study treatment and for 4 weeks after last dose of lenalidomide and for 3 months after last dose of tafasitamab (whichever is longer) Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control simultaneously: one highly effective form of contraception - tubal ligation, intrauterine device (IUD), hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and one additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Contraception should continue during therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. If needed, females of reproductive potential should be referred to a qualified provider of contraceptive methods Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential during trial therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer), even if they have undergone a successful vasectomy. Male patients must not donate sperm\n* Willing to be registered into the mandatory REVLIMID REMS (trademark) program, and willing and able to comply with the requirements of the REVLIMID REMS program\n* Able to take low-dose aspirin (81 mg) daily or an alternative form of anticoagulation\n* Subject must voluntarily sign and date an informed consent =\\\u003C 28 days prior to registration\n* Willing to return to enrolling institution for follow-up during the active monitoring phase (i.e., active treatment and clinical follow-up) of the study\n* Willing to provide mandatory blood specimens for correlative research and banking for future correlative research pertinent to this study\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant persons\n  * Nursing persons (lactating persons are eligible provided that they agree not to use their breast milk to feed while receiving treatment on the study or within 3 months of the last dose of study treatment)\n  * Men or women of reproductive potential who are unwilling to employ adequate contraception during treatment and for 4 weeks after last dose of lenalidomide or for 3 months after last dose of tafasitamab (whichever is longer)\n* Any of the following prior therapies:\n\n  * Autologous stem cell transplant =\\\u003C 90 days prior to registration\n  * Allogeneic stem cell transplant\n  * Anti-CD19 CAR T-cell therapy =\\\u003C 90 days prior to registration\n* Any central nervous system (CNS) involvement by MCL (e.g., any parenchymal, leptomeningeal, cerebrospinal fluid \\[CSF\\], cranial or spinal nerve root involvement)\n* Receiving any other treatment which would be considered as a treatment for MCL (with the exception of corticosteroid). If a patient received recent MCL treatment prior to registration, at least 5 half-lives of the drug(s) OR 14 days must have passed following the last dose for the patient to be eligible\n* Any of the following medication requirement or recent use:\n\n  * Anticoagulation with a vitamin K antagonist =\\\u003C 7 days prior to registration\n  * Requirement of a P-gp inhibitor during the study\n  * Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer during the study\n  * Use of a strong or moderate CYP3A inhibitor or inducer =\\\u003C 7 days prior to registration\n\nNOTE: Because of their effect on CYP3A4, use of any of the following within 3 days of registration or planned use during study participation is prohibited:\n\n* Grapefruit or grapefruit products\n* Seville oranges or products from Seville oranges\n* Star fruit\n\n  * Human Immunodeficiency Virus (HIV) positive. All subjects will be screened for HIV =\\\u003C 14 days prior to registration\n  * Patient with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. All subjects will be screened for hepatitis B and hepatitis C =\\\u003C 14 days prior to registration NOTE: Patients with positive hepatitis B surface antigen (HBsAg) are excluded from participation in this trial. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded from participating in this trial NOTE: Patients with positive hepatitis C antibody need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded from participating in this trial\n  * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the local investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n  * Uncontrolled intercurrent illness, in the judgement of the local investigator, including, but not limited to:\n* New York Heart Association (NYHA) class III or IV or symptomatic congestive heart failure\n* Unstable angina or acute coronary syndrome =\\\u003C 3 months prior to registration\n* Uncontrolled or symptomatic cardiac arrhythmia\n\n  * NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n* Oxygen dependent baseline lung disease (such as interstitial lung disease or chronic obstructive pulmonary disease \\[COPD\\])\n* Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment\n* Ongoing malabsorption syndrome or other condition that precludes enteral route of administration\n* Ongoing or active infection (viral, bacterial, or fungal)\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n\n  * History of the following:\n* Cerebral vascular accident within 24 weeks prior to registration\n* Myocardial infarction within 24 weeks prior to registration\n* Major surgery =\\\u003C 28 days prior to registration\n* Live vaccination =\\\u003C 28 days prior to registration\n* Life-threatening thrombosis\u002Fembolism\n* Bleeding diathesis that precludes the use of low-dose aspirin (81 mg daily) or any form of anticoagulation\n\n  * Other active primary malignancy (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =\\\u003C 2 years NOTE: If there is a history of prior malignancy, the patient must be in remission not require ongoing therapy such as radiation, chemotherapy or immunotherapy for their cancer. Patients on adjuvant hormonal therapy for adequately treated nonmetastatic breast or prostate cancer are permitted if they meet other eligibility criteria\n  * Unable to swallow oral drugs",{"count":80,"type":20},100,[23],"This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab, lenalidomide and venetoclax together may kill cancer cells more efficiently in patients with relapsed or refractory mantle cell lymphoma.",[84,85],"Recurrent Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma",{"date":87,"type":39},"2024-11-18",{"date":89,"type":39},"2024-01-04",{"date":91,"type":20},"2030-12-30",{"name":45,"class":46},2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100534424","phase-2-epcoritamab-compared-to-observation-for-treating-b-cell-lymphoma-patients-not-in-complete-remission-after-cd19-directed-car-t-therapy-100534424","NCT06238648","Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy","Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy","Inclusion Criteria:\n\n* Men and women \\>= 18 years of age\n* Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified \\[DLBCL NOS\\], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =\\\u003C 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry\n* Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at day 30 +\u002F- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)\n* Documented measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United \\[ACCRU\\] web site under Study Resources -\\> Forms)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\\\u003C 14 days prior to registration)\n* Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\>= 7.0 g\u002FdL if asymptomatic or hemoglobin \\> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: symptoms include shortness of breath, fatigue, lightheadedness\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is =\\\u003C 5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance must be \\>= 45 mL\u002Fmin using the Crockcroft- Gault formula (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms.\"\n* Negative serum pregnancy test done =\\\u003C 7 days prior to registration for a woman of childbearing potential (WOCBP) only\n\n  * NOTE: A WOCBP is a sexually mature female who:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Provide informed written consent =\\\u003C 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment and clinical follow-up)\n* Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes\n\nExclusion Criteria:\n\n* Patients post CAR-T who have bulky disease defined as a disease focus \\>= 7.5cm in diameter at day 30 +\u002F- 7 days PET-CT assessment\n* Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +\u002F- 7 days PET-CT assessment based on Lugano criteria\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)\n* Any of the following prior therapies:\n\n  * CD20xCD3 bispecific antibody at any point prior to registration\n  * CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) =\\\u003C 4 weeks prior to registration\n* Ongoing cytokine release syndrome (CRS) or neurotoxicity post CAR-T\n* Prior grade 4 CRS or neurotoxicity after most recently administered CAR-T\n* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening and based on clinical symptoms, MRI, or lumbar puncture\n* Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\\\u003C 14 days prior to registration, including COVID- 19 infection.\n\n    * NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and on suppressive therapy.\n    * NOTE: If history of treated hepatitis C virus (HCV) infection, HCV viral load must be undetectable.\n    * NOTE: Patients known to be human immunodeficiency virus (HIV) positive, but stable on anti-retroviral therapy with an undetectable HIV viral load pre-CART, are eligible for this trial.\n    * NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment\n    * NOTE: Past COVID-19 infection may be a risk factor, but if resolved symptoms and the subject is vaccinated, they may be enrolled\n  * Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class 3 or 4)\n  * Unstable angina pectoris\n  * Unstable cardiac arrhythmia present =\\\u003C 14 days prior to registration\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement\n  * History or presence of CNS disorder such as seizure disorder (not including resolved childhood febrile seizures), cerebrovascular ischemia\u002Fhemorrhage (not including transient ischemic attacks), cerebellar disease, or any autoimmune disease with CNS involvement\n* Receiving any other investigational agent which would be considered treatment for the primary neoplasm =\\\u003C 14 days prior to registration\n* Other active malignancy requiring therapy \\\u003C 2 years prior to registration (localized non-melanoma skin cancer is allowed)\n* Clinically significant cardiovascular disease, including: Myocardial infarction within 1 year prior to randomization, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV) cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities",{"count":102,"type":20},120,[23],"This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.",[106,107,108],"Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2024-09-24",{"date":111,"type":39},"2024-09-26",{"date":113,"type":39},"2024-01-31",{"date":115,"type":20},"2030-12-31",{"name":45,"class":46},6,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100410613","phase-2-modified-vr-cap-and-acalabrutinib-as-first-line-therapy-for-the-treatment-of-transplant-eligible-patients-with-mantle-cell-lymphoma-100410613","NCT04626791","Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma","A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Age 18-75 years\n* No prior therapy for mantle cell lymphoma (MCL)\n* MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician\n* Documented histological confirmation of MCL by local institutional review\n* Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion \\>= 1.5 cm in diameter) as detected by positron emission tomography (PET)\u002Fcomputed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 or \\>= 500\u002Fmm\\^3 if due to lymphomatous marrow or spleen involvement (obtained =\\\u003C 30 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm\\^3 or \\>= 75,000\u002Fmm\\^3 if due to lymphomatous marrow or spleen involvement (obtained =\\\u003C 30 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =\\\u003C 3 x upper limit of normal \\[ULN\\] is permitted) (obtained =\\\u003C 30 days prior to registration)\n* Aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 30 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) or partial thromboplastin time (PTT) =\\\u003C 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =\\\u003C 30 days prior to registration)\n* Calculated creatinine clearance must be \\>= 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained =\\\u003C 30 days prior to registration)\n* Negative pregnancy test done within =\\\u003C 14 days prior to registration for women of childbearing potential only\n* For women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group \\[CTFG\\] as having a failure rate of \\\u003C 1% per year\n* Men must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy\n* Provide informed written consent\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n* Hematologic labs must be obtained within =\\\u003C 14 days of registration\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n\nExclusion Criteria:\n\n* Prior systemic treatment for mantle cell lymphoma. Short course of steroids (=\\\u003C 7 days) for symptom management or localized radiation is permissible, as long as measurable disease outside of the radiation field exists\n* Peripheral neuropathy or neuropathic pain of grade 2 or worse as assessed by the investigator\n* Prior exposure to bortezomib or a BTK inhibitor\n* Prior anthracycline exposure unless cumulative prior exposure is under 150 mg per square meter\n* Requiring anticoagulation with warfarin or equivalent vitamin k antagonist\n* Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)\n* Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease)\n* History of stroke or intracranial hemorrhage within 6 months prior to enrollment\n* Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer\n* Requiring treatment with a proton pump inhibitor. Examples include: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or therapeutic class equivalents\n\n  * Note: H2-receptor agonists are not exclusionary\n* History of allergic reactions attributed to acalabrutinib, cytarabine, bortezomib, boron, or any of the other agents administered as part of the therapeutic regimen in this study\n* Active systemic fungal, bacterial, viral, or other infection that is worsening (defined as increasing signs\u002Fsymptoms of infection during screening) or, requires intravenous antibiotic therapy\n* Active or chronic uncontrolled hepatitis B or hepatitis C infection. Patients with positive hepatitis B core antibody positive require negative polymerase chain reaction (PCR) prior to enrollment. Hepatitis B surface antigen positive or PCR positive patients will be excluded. Patients with hepatitis C must have negative hepatitis C virus (HCV) ribonucleic acid (RNA) for inclusion\n* Co-morbid systemic illnesses or other severe concurrent disease (including major surgery within 2 weeks) which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Known to be human immunodeficiency virus (HIV) positive since antiretroviral therapy has a potential for drug interactions with acalabrutinib\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or low cardiac ejection fraction (New York Heart Association \\[NYHA\\] class 3-4 or ejection fraction \\[EF\\] \\\u003C 45%), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy =\\\u003C 2 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer localized prostate cancer, or carcinoma-in-situ of the breast or cervix. NOTE: If there is a history or prior malignancy, patients must not be receiving other specific treatment for their cancer\n* Pregnant and\u002For breastfeeding\n* Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication\n* Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. unless directly due to MCL Involvement by endoscopic or histologic evaluation\n* Major surgical procedure within 28 days of first dose of study drug. NOTE: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* Concurrent participation in another therapeutic clinical trial","75 Years",{"count":127,"type":20},45,[23],"This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.",[131],"Mantle Cell Lymphoma","2024-03-08",{"date":134,"type":39},"2024-03-12",{"date":136,"type":39},"2021-08-03",{"date":138,"type":20},"2028-08-03",{"name":45,"class":46},7,""]