[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-high-grade-b-cell-lymphoma-with-myc-and-bcl2-or-bcl6-rearrangements\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-high-grade-b-cell-lymphoma-with-myc-and-bcl2-or-bcl6-rearrangements":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,84,108,132],{"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":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100566025","phase-2-testing-the-effectiveness-of-a-combination-targeted-therapy-vipor-for-patients-with-relapsed-andor-refractory-aggressive-b-cell-lymphoma-100566025",false,"NCT06649812","Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and\u002For Refractory Aggressive B-cell Lymphoma","A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:\n\n  * Cohort 1: CD10-negative DLBCL, which includes:\n\n    * CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-\u002FBCL6- or CD10-\u002FBCL6+\u002FMUM1+ DLBCL)\n    * CD10-negative GCB DLBCL, NOS (i.e., CD10-\u002FBCL6+\u002FMUM1- DLBCL)\n    * CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)\n    * CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)\n    * CD10-negative T-cell\u002Fhistiocyte-rich large B-cell lymphoma (THRLBCL) OR\n  * Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)\n\n    * NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration\n* Patient must have relapsed and\u002For refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen\n* Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL)\n* Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU\u002FmL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment.\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy\n* Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide\n* Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment\n* Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration)\n* Hemoglobin ≥ 8 g\u002FdL (obtained ≤ 7 days prior to registration)\n* Platelets ≥ 75,000\u002FmcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration)\n* Creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL)\n* Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration.\n\n  * NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution\n* Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol\n* Patient must not have evidence of an active infection at the time of registration\n* Patient must not have the following current or prior anti-cancer treatment:\n\n  * Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration\n\n    * NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted\n  * More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates\n\n    * NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy\u002Fchimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy\n  * Radio- or toxin-immunoconjugates within 10 weeks prior to registration\n  * Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug \\[IMiD\\])\n  * Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration\n  * Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration\n\n    * NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure\n    * NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis\n\n  * NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and\u002For that has not responded to previous treatment (refractory). 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. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and\u002For refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","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","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","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","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","RECRUITING","2026-06-20",{"date":44,"type":45},"2026-06-23","ACTUAL",{"date":47,"type":45},"2025-10-07",{"date":49,"type":20},"2027-09-01",{"name":51,"class":52},"National Cancer Institute (NCI)","NIH",84,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100557279","phase-1-epcoritamab-plus-ibrutinib-for-the-treatment-of-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-100557279","NCT06536049","Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma","Phase Ib\u002FII Trial of Epcoritamab Plus Ibrutinib in Patients With Relapsed\u002FRefractory Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and\u002For immunohistochemistry is based on any representative pathology report)\n\n  * Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell\u002Fhistiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS\n  * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS\n  * Primary mediastinal B-cell lymphoma (PMBCL)\n  * Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization \\[WHO\\] classification of lymphoid neoplasms)\n  * Patients with previously diagnosed indolent lymphoma (follicular lymphoma or marginal zone lymphoma but not lymphoplasmacytic lymphoma or small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia) who have transformed to any of the above lymphoma subtypes are eligible\n* Patients must have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody:\n\n  * ≥ 2 prior systemic lymphoma treatments OR\n  * ≥ 1 prior systemic lymphoma treatment in patients with high-risk disease defined as primary refractory or relapsed within 12 months of completing anthracycline-based frontline treatment who are ineligible for chimeric antigen receptor (CAR) T cells per the treating physician. The reason for CAR T-cell treatment ineligibility should be documented\n  * Prior treatment with a BTK inhibitor is allowed if stopped due to lymphoma progression or treatment completion but not intolerance\n  * Prior treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days prior to enrollment\n  * Prior treatment with CAR T cells is allowed if ≥ 30 days prior to enrollment\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib or epcoritamab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Measurable disease (defined as \\> 1.5 cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL\n* Platelet count ≥ 75,000\u002FmcL. Platelet count ≥ 50,000\u002FmcL is allowed in case of bone marrow involvement and\u002For splenomegaly\n* Hemoglobin ≥ 8 g\u002FdL\n* Transfusion and\u002For growth factor support within 7 days (or 14 days in case of long-acting growth factors such as pegylated granulocyte colony-stimulating factor \\[G-CSF\\]) of enrollment to meet these requirements is not permitted\n* Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease or hemolysis in which case bilirubin must be \\\u003C 3 x ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \\\u003C 3 x institutional ULN\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C 3 x institutional ULN\n* Creatinine clearance \\> 45 mL\u002Fmin calculated by Cockcroft-Gault. Patients on dialysis are not eligible\n* The effects of ibrutinib and epcoritamab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 2 weeks before initiation of treatment, for the duration of study participation and for 12 months after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men must agree to refrain from sperm donation for at least 12 months after the last dose of epcoritamab\n* Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[β-hCG\\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study\n* Patients must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document. Voluntary written consent must be given before the performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n\nExclusion Criteria:\n\n* Prior therapy with a bispecific antibody targeting CD3 and CD20\n* Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms\n* Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible\n* Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \\> 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or chronic graft versus host disease AND the patient must not have taken immunosuppressive medications associated with the transplant for at least 1 month before the first scheduled dose of ibrutinib\n* Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5 half-lives prior to starting treatment on trial\n* Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis\n* Known active central nervous system (CNS) involvement by lymphoma. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at the discretion of the principal investigator\n* Active uncontrolled infection or infection requiring intravenous (IV) antibiotic therapy for \\> 2 consecutive days within 2 weeks prior to the first dose of study drug\n* Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or greater), unstable angina, or myocardial infarction within the past 6 months. Poorly controlled or clinically significant atherosclerotic vascular disease including angioplasty, cardiac or vascular stenting within 6 months of enrollment\n* Known liver cirrhosis with moderate to severe hepatic impairment (Child-Pugh class B or C)\n* Clinically significant pulmonary disease or history of bronchospasm requiring intubation, or clinically significant active interstitial lung disease or pneumonitis\n* History of cerebrovascular accident or transient ischemic attack within the 6 months before day 1, cycle 1 of treatment\n* Any prior history of intracranial hemorrhage\n* Clinically significant known bleeding diatheses or platelet dysfunction disorders.\n* Receiving treatment with coumadin\u002Fwarfarin\n* Known gastrointestinal disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of ibrutinib including the inability to swallow pills\u002Fcapsules\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent\n* Prior solid organ transplant\n* History of other malignancies that could affect compliance with the protocol or interpretation of results in the opinion of the investigator\n* Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 21 days of the first scheduled dose of ibrutinib (cycle 1 day -7)\n* Known history of HIV, active hepatitis C infection (HCV ribonucleic acid \\[RNA\\] polymerase chain reaction \\[PCR\\]-positive) and\u002For active hepatitis B infections (HBV DNA PCR-positive). If hepatitis B core (HBc) antibody is positive, the patient must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the patient must be evaluated for the presence of HCV RNA by PCR. Patients with positive HBc antibody and negative HBV DNA by PCR are eligible. Patients with positive HCV antibody and negative HCV RNA by PCR are eligible\n* Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib or epcoritamab, breastfeeding should be discontinued if the mother is treated with ibrutinib or epcoritamab\n* Patients with ongoing clinically significant grade ≥ 2 toxicity from prior therapy",{"count":62,"type":20},38,[64,23],"PHASE1","This phase Ib\u002FII trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and\u002For more effective.",[27,67,30,31,32,68,69,34,70,37,38,39,71,72],"Recurrent Grade 3b Follicular Lymphoma","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed Non-Hodgkin Lymphoma","2026-06-02",{"date":75,"type":45},"2026-06-04",{"date":77,"type":45},"2025-04-02",{"date":79,"type":20},"2027-10-31",{"name":81,"class":82},"Yazeed Sawalha","OTHER",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100596206","phase-2-fecal-microbiome-transplant-to-remodel-intestinal-microbiota-for-patients-with-relapsed-or-refractory-lymphoma-with-exposure-to-high-risk-antibiotics-who-are-receiving-chimeric-antigen-receptor-t-cells-100596206","NCT07042438","Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells","A Phase 2 Randomized Trial of Remodeling Intestinal Microbiota Using Fecal Microbiome Transplant (FMT) Among Recipients of Chimeric Antigen Receptor T Cells (CAR T)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Confirmed diagnosis of relapsed\u002Frefractory CD19 B-cell lymphomas of diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), or double-hit lymphoma (DHL) and scheduled to receive commercial CAR T treatment of YESCARTA ® for their diagnosis\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Exposure to high-risk antibiotics within 90 days of consent. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam, and vancomycin\n* Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of hope: (To be performed within 30 days prior to leukapheresis)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative)\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 12 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Major surgery in 4 months preceding enrollment\n* No live vaccine in 30 days prior to enrollment\n* Inability to swallow capsules or history of disorder with Inability to swallow FMT capsules\n* History of inflammatory bowel disorder, irritable bowel disorder\n* Severe food allergies\n* History of chronic aspiration\n* History of behavioral disorders including substance abuse disorders which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment\n* History neurocognitive disorder which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment\n* Diagnosis of primary immunodeficiency\n* Active second malignancy requiring treatment except non-melanoma skin cancer or carcinoma in situ-cervix, bladder or to non-metastatic prostate cancer which does not require treatment\n* Uncontrolled bacterial, fungal, or viral infection confirmed using clinical, laboratory and radiological findings requiring administration of intravenously (IV) antimicrobials\n* Any clinical, laboratory or radiologic findings per discretion of primary investigator will interfere with safe conduct of study treatment and compliance with study procedures\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":92,"type":20},56,[23],"This phase II trial tests how well fecal microbiome transplantation works to remodel intestinal microbiota for patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) with exposure to high-risk antibiotics who are receiving chimeric antigen receptor (CAR) T cells. Fecal microbiome transplantation consists of fecal microbiota from healthy donors with healthy gut microbiota that allows re-population of the patient's microbiome with diverse protective microorganisms. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Part of the treatment for CAR T therapy involves high doses of chemotherapy. This, along with prior exposure to high strength antibiotics, can damage patient's intestinal microbiota. Giving fecal microbiome transplantation may improve clinical response by repairing intestinal microbiota for patients with relapsed or refractory lymphoma who had exposure to high-risk antibiotics.",[27,30,96,34,37,97],"Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","2026-03-03",{"date":100,"type":45},"2026-03-05",{"date":102,"type":45},"2026-02-11",{"date":104,"type":20},"2029-01-23",{"name":106,"class":82},"City of Hope Medical Center",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":107},"100497272","phase-1-tegavivint-for-treating-patients-with-relapsed-or-refractory-large-b-cell-lymphoma-100497272","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",{"count":116,"type":20},18,[64],"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.",[120,28,30,31,121,35,37,38,122],"Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-02-24",{"date":125,"type":45},"2026-02-27",{"date":127,"type":45},"2023-03-06",{"date":129,"type":20},"2028-03-05",{"name":131,"class":82},"Lapo Alinari",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":139,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":107},"100296220","phase-2-combination-chemotherapy-in-treating-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-lymphoblastic-lymphoma-burkitt-lymphomaleukemia-or-double-hit-lymphomaleukemia-100296220","NCT03136146","Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma\u002FLeukemia, or Double-Hit Lymphoma\u002FLeukemia","Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)","Inclusion Criteria:\n\n* Relapsed\u002Frefractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):\n\n  * Relapsed and\u002For refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)\n  * Relapsed and\u002For refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia\u002Flymphoma or \"double-hit\" leukemia\u002Flymphoma (phase II only)\n* At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset\n* Age older than 15 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3 (There may be certain patients with performance status \\[PS\\] 3 in the context of rapidly proliferative\u002Frefractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)\n* Serum bilirubin =\\\u003C 1.5 mg\u002FdL\n* Serum glutamate pyruvate transaminase (SGPT) =\\\u003C 3 x upper limit normal (ULN), with exception for Gilbert's syndrome\n* Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL\u002Fmin\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active \\>= grade 3 peripheral neuropathy\n* Active hepatic graft-versus-host disease\n* Known positivity for hepatitis B or C\n* Pregnancy\n* Breast feeding","15 Years",{"count":141,"type":20},42,[23],"This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma\u002Fleukemia, or double-hit lymphoma\u002Fleukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[145,146,147,148,149,30,150,151,152,37,153],"Recurrent Acute Lymphoblastic Leukemia","Recurrent Adult Lymphoblastic Lymphoma","Recurrent Burkitt Leukemia","Recurrent Burkitt Lymphoma","Recurrent Childhood Lymphoblastic Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Burkitt Leukemia","Refractory Burkitt Lymphoma","Refractory Lymphoblastic Lymphoma","2026-02-12",{"date":156,"type":45},"2026-02-17",{"date":158,"type":45},"2017-08-09",{"date":160,"type":20},"2027-08-01",{"name":162,"class":82},"M.D. Anderson Cancer Center"]