[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-diffuse-large-b-cell-lymphoma-activated-b-cell-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-diffuse-large-b-cell-lymphoma-activated-b-cell-type":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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},"100497272","phase-1-tegavivint-for-treating-patients-with-relapsed-or-refractory-large-b-cell-lymphoma-100497272",false,"NCT05755087","Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma","Phase Ib Trial of Tegavivint in Patients With Relapsed\u002FRefractory C-MYC Overexpressing Large B-Cell Lymphoma","Inclusion Criteria:\n\nOne of the following three conditions:\n\n* Relapsed\u002Frefractory histologically confirmed germinal center B-cell-like (GCB) and non-GCB diffuse large B cell lymphoma (DLBCL) with the following features:\n\n  * Increased expression of MYC (\\>= 40%) and BCL2 (\\>= 50%) by immunohistochemistry (IHC) or\n  * Presence of isolated MYC translocation Or\n* Relapsed\u002Frefractory histologically confirmed high-grade B-cell lymphoma (HGBCL) (double hit \\[DH\\] and triple hit \\[TH\\]) with translocations of MYC and BCL2 and\u002For BCL6 Or\n* Histologic transformation of indolent non-Hodgkin's lymphoma (NHL) to DLBCL\n\n  * Presence of BCL2 translocation with increased expression of MYC (≥40%) with or without MYC translocation\n* Patients must have had at least two prior systemic therapies\n* Patients must be ineligible for or refused autologous or allogenic hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy. Prior autologous stem cell transplant and\u002For CAR-T are allowed, if received \\>= 3 months prior to enrollment\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patients must have radiographically measurable disease by standard positron emission tomography (PET) uptake with at least one site of measured disease by standardized uptake value (SUV)\n* Absolute neutrophil count (ANC) ≥ 500\u002FmcL\n* Platelet count ≥ 25,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x the upper limit of the normal range (ULN)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 x institutional ULN\n* Creatinine clearance \\>= 60 ml\u002Fmin by Cockcroft-Gault (actual body weight will be used to estimate creatinine clearance)\n* Patients must be willing and able to understand and give written informed consent and comply with all study related procedures\n* Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one hormonal contraceptive (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from sex for the duration of study participation and for 4 months following completion of tegavivint administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nContraception includes:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n* Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient\n* Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception\n* Sexually active males must use a condom during intercourse while taking drug and for 4 months after stopping study treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint or other agents used in study\n* Known active central nervous system (CNS) lymphoma, history of CNS involvement allowed if in remission for \\>= 3 months\n* Evidence of chronic active Hepatitis B, chronic active Hepatitis C infection\n* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy (e.g., strong CYP3A inhibitors and\u002For concomitant medications that are excluded) are ineligible because of the potential for pharmacokinetic interactions with tegavivint\n* Known history of active TB (Bacillus Tuberculosis)\n* Major surgery within 3 weeks prior to start of study treatment\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality or corrected QT interval (QTc) \\> 480 msec\n* Uncontrolled concurrent illness including, but not limited to: ongoing or active infection (Viral, bacterial, fungal or other)\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tegavivint\n* Patients with abnormal serum chemistry values other than the specific limits detailed above, that in the opinion of the investigator is considered to be clinically significant, should be discussed with the Study PI before being enrolled in the study\n* Personal history of malignancy except:\n\n  * Cervical intraepithelial neoplasia;\n  * Skin basal cell carcinoma;\n  * Treated localized prostate carcinoma with prostate specific antigen (PSA) \\\u003C1 ng\u002FmL or untreated indolent prostate cancer\n  * Neoplasia treated with curative intent, in remission for at least three years and considered at low risk of relapse","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of tegavivint in treating patients with large b-cell lymphomas that has come back (relapsed) or does not respond to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint may help control the disease.",[26,27,28,29,30,31,32,33,34],"Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","RECRUITING","2026-02-24",{"date":38,"type":39},"2026-02-27","ACTUAL",{"date":41,"type":39},"2023-03-06",{"date":43,"type":20},"2028-03-05",{"name":45,"class":46},"Lapo Alinari","OTHER",1,{"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":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100580213","phase-2-golcadomide-and-rituximab-as-bridging-therapy-for-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-before-car-t-cell-therapy-100580213","NCT06834373","Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy","Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Prior to CAR-T for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and\u002For refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy, no more than two lines of therapy are permitted:\n\n  * Diffuse large B-cell lymphoma not otherwise specified (NOS) including:\n\n    * Transformed lymphoma\n    * Germinal center B-cell type\n    * Activated B-cell type\n  * High-grade B-cell lymphoma (HGBCL), NOS\n  * High grade B-cell lymphoma with MYC and BCL2 translocation\n  * Primary mediastinal (thymic) large B-cell lymphoma\n  * Grade 3B follicular lymphoma\n  * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n  * Large B-cell lymphoma with IRF4 rearrangement\n  * Primary cutaneous diffuse large B-cell lymphoma (DLBCL), leg type\n  * Epstein-Barr virus (EBV) positive DLBCL, NOS\n  * DLBCL associated with chronic inflammation\n  * Intravascular large B-cell lymphoma\n  * ALK positive large B-cell lymphoma\n  * NOTE: Richters transformation patients are excluded\n* Measurable disease by PET-CT with at least one lymph node or other type of lesion that has a size \\> 1.5 cm in the transverse diameter, as defined by Lugano classification\n\n  * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible\n* Patient is potentially eligible for CAR-T therapy as determined by treating physician\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Hemoglobin \\> 7.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FmcL (obtained ≤ 14 days prior to registration); growth factor support allowed at physician discretion\n* Platelet count ≥ 75,000\u002FmcL (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration); if total bilirubin is \\> 1.5 ULN, direct bilirubin must be normal\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma) (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Have 2 negative pregnancy tests as verified by the investigator prior to starting CC-99282:\n\n  * A negative serum pregnancy test (sensitivity of at least 25 mIU\u002FmL) at screening (between 10 to 14 days prior to cycle 1 day 1)\n  * A negative serum or urine pregnancy test (investigator's discretion) within 24 hours prior to cycle 1 day 1 of study treatment\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Subjects must agree not to donate blood while receiving golcadomide, during dose interruptions and for ≥ 28 days following the last dose of golcadomide\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n* Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n\n  * Persons of childbearing potential (PCBP) unwilling to use two reliable forms of contraception simultaneously or to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal or postovulation methods\\] and withdrawal are not acceptable methods of contraception) from heterosexual contact during the following time periods related to this study:\n  * For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide\n  * Examples of highly effective methods of contraception:\n\n    * Intrauterine device (IUD)\n    * Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system \\[IUS\\], medroxyprogesterone acetate depot injections, ovulation inhibitory\n    * Progesterone-only pills \\[e.g., desogestrel\\])\n    * Tubal ligation\n    * Partner's vasectomy\n  * Examples of additional effective methods:\n\n    * Male condom\n    * Diaphragm\n    * Cervical cap\n  * Persons who can father a child unwilling to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal or post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.) or unwilling to use a condom during sexual contact with a pregnant person or a PCBP during treatment and dose interruptions, and for \\> 28 days following the last dose of golcadomide, even if they have undergone a successful vasectomy\n  * Persons who can father a child and are unwilling to refrain from donating semen or sperm while receiving golcadomide, during dose interruptions, or for ≥ 28 days following the last dose of golcadomide\n* Life expectancy \\\u003C 3 months\n* Any of the following prior therapies:\n\n  * Any prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to registration\n  * Any prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to registration, whichever is shorter\n\n    * Exception: Monoclonal and bispecific antibodies is acceptable\n  * Prior therapy with golcadomide ≤ 4 weeks prior to registration\n  * Prior autologous stem cell transplantation (SCT) ≤ 3 months prior to registration. If subject had autologous SCT \\> 3 months prior to the start of registration, any treatment-related toxicity is unresolved (grade \\> 1)\n  * Major surgery ≤ 3 weeks prior to registration\n  * Chemotherapy ≤ 2 weeks prior to registration\n  * Concomitant radiation therapy; local palliative radiotherapy is permitted\n* Co-morbid systemic illnesses or other severe concurrent disease or cancer 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* Impaired cardiac function or clinically significant cardiac diseases including, but not limited to:\n\n  * Symptomatic congestive heart failure\n  * History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy (such as interstitial lung disease or chronic obstructive pulmonary disease \\[COPD\\])\n  * Any other conditions that would limit compliance with study requirements\n* Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to registration. If subject had prior allogeneic SCT \\> 6 months prior to registration, any treatment-related toxicity is unresolved (grade \\>1)\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy, as there is currently no safety data in HIV positive patients\n* Subject has known chronic active hepatitis B or C virus (HBV\u002FHCV) infection\n\n  * Exception: Patients with HBV and an undetectable viral load who are on suppressive therapy and\u002For those with HCV and an undetectable viral load are allowed\n* Concurrent administration of strong or moderate CYP3A4\u002F5 inhibitors and inducers within 14 days or 5 half-lives, whichever is longer before the study treatment administration\n* Receiving any other investigational agent which would be considered as a treatment for lymphoma.\n\n  * Exception: Corticosteroids are allowed\n* Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy\n* History of deep venous thrombosis\u002Fembolism, threatening thromboembolism or known thrombophilia. Patients with a history of deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE) or thrombophilia may still participate if they are willing to be on full anticoagulation during treatment. Full anticoagulation is defined as Warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses. The rationale for this requirement is that golcadomide therapy is associated with an increased risk of thrombosis. Patients with no history of DVT\u002FPE or thrombophilia are not required to take anticoagulation and\u002For anti-platelet prophylaxis\n\n  * NOTE: If a patient develops a thrombotic event, they must be able and willing to receive anticoagulation therapy with aspirin 81-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or Warfarin. This is due to an increased risk of thrombosis in patients treated with golcadomide without prophylaxis\n* Live COVID-19 vaccine administered ≤ 28 days prior to registration",{"count":56,"type":20},41,[58],"PHASE2","This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.",[61,62,63,26,64,27,65,66,67,68,69,70,71,72,73,74,75,76,30,77,31,78,79,80,81,82,83,84,85,86,87],"Large B-Cell Lymphoma With IRF4 Rearrangement","Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma","Recurrent ALK-Positive Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation","Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent Grade 3b Follicular Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent Intravascular Large B-Cell Lymphoma","Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Recurrent T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Refractory Aggressive B-Cell Non-Hodgkin Lymphoma","Refractory ALK-Positive Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory Grade 3b Follicular Lymphoma","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory Intravascular Large B-Cell Lymphoma","Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Refractory Transformed Non-Hodgkin Lymphoma","2026-01-26",{"date":90,"type":39},"2026-01-28",{"date":92,"type":39},"2025-04-02",{"date":94,"type":20},"2027-03-03",{"name":96,"class":46},"Mayo Clinic",7]