[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-mantle-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-mantle-cell-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,65,78,100,128,165,185,210,237,258],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054084","phase-2-testing-the-anti-cancer-drug-glofitamab-in-patients-with-mantle-cell-lymphoma-a-type-of-blood-cancer-whose-disease-returned-after-car-t-cell-therapy-100054084",false,"NCT07003295","Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy","A Phase II Study of Glofitamab for Relapsed\u002FRefractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen)\n* Patients must have been previously treated with an anti-CD19 CAR T-cell therapy and have failed or been intolerant to Bruton's tyrosine kinase (BTK) inhibition. Both commercial and investigational CAR-T products which target CD19 will be allowed, including dual-targeting products\n* Patients must have at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab and obinutuzumab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 50,000\u002FmcL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x institutional ULN if the patient has Gilbert syndrome\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Patients with human immunodeficiency virus (HIV) infection are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months\n* Patients with a history of hepatitis B virus (HBV) infection or positive total hepatitis B core antibody (HBcAb) are eligible if the hepatitis B surface antigen (HBsAg) is negative and HBV DNA viral load is undetectable by polymerase chain reaction (PCR) at the time of screening. Such patients must be managed with appropriate anti-viral therapy, if indicated, and must be willing to undergo HBV DNA testing on day 1 of each cycle and every 3 months for at least 12 months after the final cycle of study treatment\n* Patients with a history of hepatitis C virus (HCV) infection or positive HCV antibody are eligible if HCV ribonucleic acid (RNA) viral load is undetectable by PCR\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are asymptomatic from CNS involvement\n* Patients with new, progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that patients are asymptomatic and immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\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, such as patients with prostate cancer or breast cancer receiving hormonal therapy\n* The effects of glofitamab and obinutuzumab on the developing human fetus are unknown. For this reason and because glofitamab and obinutuzumab are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of glofitamab and 6 months after completion of obinutuzumab administration. Women of childbearing potential must use effective contraceptive precautions 2 months after completion of glofitamab treatment and 18 months after the last dose of obinutuzumab treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab and obinutuzumab\n* Pregnant women are excluded from this study because glofitamab and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with glofitamab and obinutuzumab, breastfeeding should be discontinued if the mother is treated with glofitamab and obinutuzumab\n* Patients with active CRS or requiring intervention for CRS within 14 days prior to study enrollment\n* Patients with active neurotoxicity or requiring intervention for neurotoxicity within 14 days prior to study enrollment\n* Patients requiring antimicrobial treatment or hospitalization for active infection within 14 days prior to study enrollment for known active bacterial, viral (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\]), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Infection must be completely resolved prior to initiation of study treatment\n* Patients receiving systemic immunosuppressive medications within 14 days prior to study enrollment, including, but not limited to: prednisone ≥ 20 mg per day, azathioprine, methotrexate, anti-tumor necrosis factor agents, anti-interleukin-6\u002F6R agents, or anti-interleukin 1 agents, are not eligible. The use of inhaled corticosteroids is permitted\n* Patients with known or suspected chronic active Epstein Barr virus (EBV) or cytomegalovirus (CMV) infection\n* Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Patients with prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Patients with known history of progressive multifocal leukoencephalopathy\n* Patients with current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed\n* Patients with the significant cardiovascular disease, including New York Heart Association class III or IV or otherwise symptomatic heart failure (stage C or D), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina\n* Patients who have undergone major surgery for non-diagnostic purposes within 4 weeks before first study treatment\n* Patients who have received a live attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Patients with a positive SARS-CoV-2 test 7 days prior to enrollment\n* Patients with current or past history of Waldenström macroglobulinemia\n* Patients with an active autoimmune disease that could be exacerbated by immunotherapy, excluding those with a remote history or well-controlled autoimmune disease","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they 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) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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). Giving glofitamab and obinutuzumab may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.",[26,27],"Recurrent Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-07-08",{"date":36,"type":20},"2027-08-31",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100644823","phase-2-nemtabrutinib-with-car-t-therapy-in-relapsedrefractory-mantle-cell-lymphoma-100644823","NCT07673367","Nemtabrutinib With CAR T Therapy in Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase 2 Trial of Nemtabrutinib in Combination With Brexu-cel for Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* • Confirmed diagnosis of relapsed or refractory mantle cell lymphoma who meets institutional eligibility criteria to receive standard of care brexu-cel therapy\n\n  * Is an individual of any sex\u002Fgender, who are at least 18 years of age on the day of signing informed consent with confirmed diagnosis of R\u002FR MCL will be enrolled in this study\n  * The participant (or legally acceptable representative if applicable) has provided documented informed consent\u002Fassent for the trial\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n  * The ability to swallow and retain oral medication\n\n    \\* NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunal (J-PEG) tube\n  * Participants who are hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation\n\n    \\* Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg and anti-HBV. Hepatitis B screening tests are not required unless:\n    * Known history of HBV infection\n    * As mandated by local health authority\n  * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\n    * Participants must have completed curative anti-viral therapy at least 4 weeks prior to allocation\n    * Hepatitis C screening tests are not required unless:\n\n      * Known history of HCV infection\n      * As mandated by local health authority\n  * Participants with HIV are eligible if they meet ALL of the following criteria:\n\n    \\* The CD4 count is ≥ 350 cells\u002FuL at screening\n    * The HIV viral load is below the detectable level as per locally available testing\n    * Are on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n    * NOTE: ART includes drugs, which are NOT strong cytochrome P450 (CYP)3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study)\n    * HIV screening tests are not required unless:\n\n      * Known history of HIV infection\n      * As mandated by local health authority or institutional standards\n    * Are compliant with their ART\n  * Adequate organ function as defined. Specimens must be collected within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase\n  * Absolute neutrophil count (ANC) ≥ 500\u002FuL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (granulocyte colony-stimulating factor \\[GCSF\\] and thyroid peroxidase \\[TPO\\] agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Platelets ≥ 25000\u002FuL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (GCSF and TPO agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Hemoglobin ≥ 7 g\u002FdL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (GCSF and TPO agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Creatinine ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) OR measured or calculated creatinine clearance ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (glomerular filtration rate \\[GFR} can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n    \\* Creatinine clearance (CrCl) should be calculated per institutional standard\n  * Total bilirubin ≤ 1.5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN\n  * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Participants assigned male sex at birth\n\n    \\* If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n    * Nemtabrutinib: 12 days\n    * Cyclophosphamide: 4 months\n    * Fludarabine: 3 months\n    * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n    * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n\n      \\*\\*\\* Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak\n\n      \\* Note: Participants capable of producing ejaculate whose partner is pregnant, or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate\n    * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n  * Participants assigned female sex at birth\n\n    * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n      * Is not a person of childbearing potential (POCBP) OR\n      * Is a POCBP and:\n      * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n        * Nemtabrutinib: 1 month\n        * Cyclophosphamide: 12 months\n        * Fludarabine: 6 months\n      * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n      * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive\n      * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib\n      * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n\nExclusion Criteria:\n\n* • Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)\n\n  * Diagnosis of Richter transformation including any history of Richter's transformation\n  * Active central nervous system (CNS) involvement with lymphoma. Previously treated CNS disease allowed as long as confirmed disease control based on imaging and negative cerebrospinal fluid (CSF) cytology\n  * Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened following completion of IV antibiotic course (24 hour washout period required). PO antibiotics are allowed if infection is considered controlled by treating physician\n  * AIDS defining opportunistic infection in the past 12 months prior to screening\n  * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n  * Corrected QT interval (QTc) prolongation (defined as a Fridericia's formula-corrected QT interval \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin)\n  * Known allergy\u002Fsensitivity (≥ grade 3) to nemtabrutinib or any of the excipients\n  * History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding\n  * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n\n    \\* NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of bladder or cervix\n  * A POCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\n    \\* Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n  * Patients with refractory MCL to non-covalent BTK inhibitor such as pirtobrutinib or nemtabrutinib. Patients who have relapsed or refractory MCL after prior covalent BTK inhibitors are allowed. Patients who have received prior non-covalent BTK inhibitors and achieved at least partial response are allowed\n  * Currently being treated with the following drugs:\n\n    * P-glycoprotein (P-gp) substrates with a narrow therapeutic index\n    * CYP3A strong inducers\n    * CYP3A strong inhibitors\n    * NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment\n  * Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks or 5 half-lives before start of study treatment (whichever is shorter). Subjects can be screened pending required wash-out period before starting nemtabrutinib\n  * Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids\n\n    \\* NOTE: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted\n  * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed\n  * Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited\n  * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n  * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Hypogammaglobulinemia will not be considered state of immunodeficiency\n  * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n  * Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications\n\n    \\* NOTE: Biopsy and placement of central venous access devices are not considered major surgery\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n  * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",{"count":49,"type":20},25,[23],"This phase II trial tests the effect of nemtabrutinib in combination with brexucabtagene autoleucel (brexu-cel) 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). Nemtabrutinib, a BTK inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chimeric antigen receptor (CAR) T-cell therapy, such as brexu-cel, 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 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. Chemotherapy, such as fludarabine and cyclophosphamide, are given before CAR T cell therapy to help kill cancer cells in the body and help make room for the CAR T cells. Giving nemtabrutinib in combination with brexu-cel may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma.",[26,27],"NOT_YET_RECRUITING","2026-06-29",{"date":56,"type":32},"2026-07-01",{"date":58,"type":20},"2026-07-31",{"date":60,"type":20},"2032-07-31",{"name":62,"class":63},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":66,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":24,"conditions":69,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":77},"100593196",{"count":19,"type":20},[23],[26,27],"2026-06-02",{"date":72,"type":32},"2026-06-03",{"date":74,"type":20},"2026-08-14",{"date":36,"type":20},{"name":38,"class":39},7,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":64},"100640069","phase-1-golcadomide-in-combination-with-rituximab-for-the-treatment-of-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-100640069","NCT07578077","Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma","A Phase 1\u002F2 Study of the CELMoD Agent Golcadomide in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\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* Ability to adhere to the study protocol\n* Age: ≥ 18 years\n* Eastern Clinical Oncology Group (ECOG) ≤ 2\n* Histologically confirmed diagnosis of MCL\n\n  * Immunohistochemistry of the biopsy\n  * Flow cytometry of the biopsy\n* Relapsed\u002F refractory disease\n* Relapsed\u002Frefractory (R\u002FR) MCL after at least one line of therapy including resistant or intolerant to a cBTKi\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Ability to swallow pills\n* Without bone marrow involvement: Absolute neutrophil count (ANC) \\> 1.5 × 10\\^9\u002FL (ANC \\> 1,500\u002Fmm\\^3)\n\n  * With bone marrow involvement: ANC \\> 1.0 × 10\\^9\u002FL (ANC \\> 1000\u002Fmm\\^3)\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement. For patients with significant marrow involvement, eligibility may be confirmed at the discretion of the treating investigator\n* Without bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * With bone marrow involvement: Platelets ≥ 50,000\u002Fmm\\^3\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 1.5 × ULN if Gilbert's disease)\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 × ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN unless elevation is attributable to underlying disease, in which case ALT ≤ 3.0 × ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 × ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Seronegative for HIV\n* Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative)\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* Woman of childbearing potential must have a negative pregnancy test using a highly sensitive assay (minimum sensitivity 25 IU\u002FL) performed within 10 to 14 days and again within 24 hours prior to receiving the first dose of golcadomide\u002FBMS-986369\n* Agreement by females of childbearing potential to use two effective methods of contraception simultaneously without interruption, for at least 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions, and for at least 28 days after the last dose of golcadomide\u002FBMS-986369. The two methods of contraception must include one highly effective method and one additional effective method. Compliance will be documented using the Clinical Trial Pregnancy Risk Awareness Checklist, which must be completed and provided to participants at screening and prior to dispensing of study drug. An individual of childbearing potential (IOCBP) is defined as:\n\n  * A person who has achieved menarche, has not undergone a documented hysterectomy or bilateral oophorectomy, and has not been naturally postmenopausal for at least 12 consecutive months. Amenorrhea resulting from medical interventions (such as cancer therapy), rather than natural menopause, does not exclude childbearing potential.\n\nCriteria:\n\n* Achievement of menarche (onset of menstruation).\n* No history of surgical sterilization:\n\n  * No documented hysterectomy\n  * No documented bilateral oophorectomy\n* Not naturally postmenopausal:\n\n  * Defined as absence of menses for ≥ 12 consecutive months due to natural causes (not due to medical interventions such as chemotherapy, hormonal therapy, or radiotherapy)\n* Amenorrhea due to medical causes (e.g., cancer therapy, hormonal treatment) does not qualify as natural menopause and does not exclude childbearing potential\n\nExclusion Criteria:\n\n* Chemotherapy, radiation therapy (except for palliative radiation therapy \\[XRT\\]), biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy\n* Strong CYP3A4 inducers\u002F inhibitors within 14 days prior to day 1 of protocol therapy\n* Herbal medications\n* History of metastatic cancer\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * New York Heart Association (NYHA) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents\n* Clinically significant uncontrolled illness\n* Known seropositive or active infection with HIV, HBV, or HCV\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment\n* Females only: Pregnant or breastfeeding\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":86,"type":20},58,[88,23],"PHASE1","This phase I\u002FII trial tests the safety, side effects, best dose and effectiveness of golcadomide in combination with rituximab in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). 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 in combination with rituximab may better treat patients with relapsed or refractory mantle cell lymphoma.",[26,27],"2026-05-05",{"date":93,"type":32},"2026-05-11",{"date":95,"type":20},"2026-12-21",{"date":97,"type":20},"2030-04-21",{"name":99,"class":63},"City of Hope Medical Center",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":64},"100580573","phase-2-sonrotoclax-rituximab-and-zanubrutinib-in-treating-participants-with-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-and-mantle-cell-lymphoma-100580573","NCT06839053","Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma","SONIC: Escalated Inpatient Ramp-Up of Sonrotoclax in Patients With Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Mantle Cell Lymphoma (MCL) (SONIC Study)","Inclusion Criteria:\n\n* Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or analyses\n* Age 18 years or older\n* Confirmed diagnosis (per World Health Organization \\[WHO\\] guidelines, unless otherwise noted) of one of the following:\n\n  * CLL\u002FSLL COHORT: CLL\u002FSLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria:\n\n    * Meeting the following sets of prior treatment criteria:\n\n      * For the R\u002FR cohort, disease that relapsed after, or was refractory to, at least 1 prior therapy\n      * For the treatment-naïve cohort, patients should have no prior treatment for CLL\u002FSLL (other than 1 aborted regimen \\\u003C 2 weeks in duration and \\> 4 weeks before enrollment)\n    * Requiring treatment per International Workshop on CLL (iwCLL) criteria\n  * MCL COHORT: WHO-defined MCL\n\n    * R\u002FR MCL is defined as a disease that relapsed after, or was refractory to, at least 1 prior systemic therapy\n* Measurable disease, defined as:\n\n  * CLL\u002FSLL: at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) or clonal lymphocytes \\>= 5 x 109\u002FL present on peripheral blood flow cytometry\n  * MCL, or SLL: at least 1 lymph node \\> 1.5 cm in the longest diameter OR 1 extranodal lesion \\> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT\u002FMRI\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^9\u002FL =\\\u003C 7 days before the first dose of the study drug with or without growth factor support. There is an exception for patients with bone marrow involvement, in which case ANC must be \\>= 0.75 x 10\\^9\u002FL before the first dose of the study drug\n* Platelets \\> 75,000 x 10\\^9\u002FL (\\> 75,000 cells\u002Fmm\\^3) =\\\u003C 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions. Patients with bone marrow involvement will be allowed to have a platelet count \\> 50,000 x 10\\^9\u002FL (\\> 50,000 cells\u002Fmm\\^3) =\\\u003C 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions\n* Hemoglobin \\> 75 g\u002FL =\\\u003C 7 days before the first dose of the study drug (with or without transfusion)\n* Creatinine clearance or glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin as estimated by one of the following:\n\n  * Cockcroft-Gault equation\n  * Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n  * 24-hour urine collection\n* Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase =\\\u003C 2 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase =\\\u003C 2 x ULN\n* Total bilirubin level =\\\u003C 1.5 x ULN (unless documented Gilbert's syndrome). For patients with documented Gilbert's syndrome, total bilirubin may exceed this value, but direct bilirubin must be =\\\u003C 1.0 x ULN\n* Serum amylase =\\\u003C 1.5 x ULN\n* Serum lipase =\\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test =\\\u003C 7 days before the first dose of the study drug. In addition, they must use a highly effective method of birth control initiated before the first dose of the study drug, for the duration of the study treatment period, and for \\>= 180 days after the last dose of the study drug\n\n  * NOTE: WOCBP is a woman who: 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 (ie, has had menses at any time in the preceding 24 consecutive months)\n  * NOTE: Highly effective contraceptive methods include the following:\n\n    * Combined (estrogen and progestogen-containing) hormonal contraception associated with the inhibition of ovulation. Combined hormonal contraception may be oral, intravaginal, or transdermal\n\n      * Progestogen-only hormonal contraception associated with the inhibition of ovulation. Progesterone-only hormonal contraception may be oral, injectable, or implantable\n      * An intrauterine device\n      * Intrauterine hormone-releasing system\n      * Bilateral tubal\n    * Vasectomized partner\n\n      * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day before the first dose of study treatment, for the duration of the study, and for \\>= 180 days after the last dose of study drug. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception\n  * Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above\n  * For patients using hormonal contraceptives such as birth control pills or devices, a second barrier method of contraception (e.g., condoms) must be used\n* Nonsterile men must use a highly effective method of birth control along with barrier contraception for the duration of the study treatment period and for ≥ 180 days after the last dose of the study drug. During this same period, they must not donate sperm. Sterile men must use barrier contraception\n* Life expectancy of \\> 6 months\n* Able to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Exposure to a Bcl-2 inhibitor within the last 12 months or a history of disease progression while taking a Bcl-2 inhibitor\n* Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, melanoma, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score =\\\u003C 6 prostate cancer\n* Underlying medical conditions that may render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results\n* Known current central nervous system involvement by lymphoma\u002Fleukemia\n* Known plasma cell neoplasm other than a monoclonal gammopathy of undetermined significance (MGUS), prolymphocytic leukemia, or history of or currently suspected Richter's syndrome\n* Prior autologous stem cell transplant unless \\>= 3 months after transplant; or prior chimeric antigen receptor T-cell (CAR-T) therapy unless \\>= 3 months after cell infusion\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for the treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* History of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* Use of the following substances prior to the first dose of the study drug:\n\n  * =\\\u003C 28 days before the first dose of the study drug:\n\n    * Any biologic and\u002For immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, e.g., rituximab, and\u002For cancer vaccine therapy). If biological and\u002For immunologic-based therapy(ies) are used for non-oncological indications, enrollment will be at the discretion of the principal investigator (PI)\n  * =\\\u003C 14 days before the first dose of the study drug:\n\n    * Systemic chemotherapy or radiation therapy\n  * =\\\u003C 7 days before the first dose of the study drug:\n\n    * Corticosteroid given with antineoplastic intent\n  * =\\\u003C 3 days (or 5 half-lives; whichever is shorter) before the first dose of the study drug:\n\n    * Bruton's tyrosine kinase inhibitor (BTKi) or other small molecule inhibitor is given with antineoplastic intent\n* Active fungal, bacterial, and\u002For viral infection requiring systemic therapy\n\n  * Note: oral antibiotics for minor bacterial infections are allowed\n* Major surgery =\\\u003C 4 weeks before the first dose of study treatment\n* Toxicity from prior anticancer therapy that has not recovered to grade =\\\u003C 1 (except for alopecia, ANC, and platelet count; for ANC and platelet count)\n* Clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction =\\\u003C 6 months before screening\n  * Unstable angina =\\\u003C 3 months before screening\n  * New York Heart Association class III or IV congestive heart failure\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n  * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements, at screening, showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg\n* Known infection with human immunodeficiency virus (HIV) or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:\n\n  * Presence of viral hepatitis B surface antigen (HBsAg) or viral hepatitis B core antibody (HBcAb)\n\n    * Note: Patients with the presence of HBcAb, but absence of HBsAg, are eligible if HBV deoxyribonucleic acid (DNA) is undetectable and if they are willing to take HBV reactivation prophylaxis and undergo monitoring for HBV reactivation\n  * Presence of HCV antibody\n\n    * Note: Patients with the presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable and if they are willing to undergo monitoring for HCV reactivation\n* Pregnant or lactating women\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedure, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Inability to comply with study procedures\n* Receiving any treatment with a strong or moderate CYP3A4 inhibitor =\\\u003C 14 days (or 5 half-lives, whichever is longer) before the first dose of sonrotoclax\n* Unwillingness to stop consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before the first dose of sonrotoclax or during the study\n* Receiving any treatment with a strong CYP3A4 inducer =\\\u003C 14 days (or 5 half-lives, whichever is longer) before first dose of sonrotoclax\n* History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis and acute lung diseases\n* Autoimmune anemia and\u002For thrombocytopenia that is poorly controlled by corticosteroids or other standard therapy\n* Ongoing, drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension\n* Receiving drugs known to prolong the QT\u002Fcorrected QT (QTc) interval\n* Vaccination with a live vaccine =\\\u003C 35 days before the first dose of the study drug\n\n  * Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed",{"count":108,"type":20},30,[23],"This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.",[112,113,114,26,115,116,27,117,118],"Chronic Lymphocytic Leukemia","Mantle Cell Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Small Lymphocytic Lymphoma","Refractory Chronic Lymphocytic Leukemia","Refractory Small Lymphocytic Lymphoma","Small Lymphocytic Lymphoma","2026-04-17",{"date":121,"type":32},"2026-04-22",{"date":123,"type":32},"2025-06-02",{"date":125,"type":20},"2032-07-01",{"name":127,"class":63},"Fred Hutchinson Cancer Center",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":64},"100582107","phase-1-zanubrutinib-in-combination-with-sonrotoclax-for-the-treatment-of-underrepresented-ethnic-and-racial-minorities-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-100582107","NCT06859008","Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Feasibility of Treating Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic\u002FRacial Minorities","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* Age: ≥ 18 years on the day of signing the informed consent form\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Patients are of the following self-identified racial\u002Fethnic groups:\n\n  * Cohort 1: Patients in any of the following categories:\n\n    * Black or African American\n    * Hispanic or Latino\n    * American Indian\u002FNative Alaskan\n    * Pacific Islander\u002FNative Hawaiian\n    * Any other patient that does not fit the definition of Cohort 2\n  * Cohort 2: Patients in either of following categories:\n\n    * Non-Hispanic White\n    * Non-Hispanic Asian\n* Confirmed diagnosis (per World Health Organization \\[WHO\\] guidelines, unless otherwise noted) of one of the following disease subtypes. Note that for disease subtypes that are known to respond to BTK inhibitor (BTKi) and\u002For BCL2 inhibitor (BCL2i) (e.g., marginal zone lymphoma \\[MZL\\], mantle cell lymphoma \\[MCL\\], CLL\u002FSLL), newly diagnosed or r\u002Fr patients are allowed\n\n  * Diffuse large B cell lymphoma (DLBCL)\n\n    * R\u002FR DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 2 prior lines of therapy. Patients should be considered by the investigator to be refractory to or not a candidate for approved therapies with proven efficacy including but not limited to chimeric antigen receptor (CAR) T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Follicular lymphoma (FL)\n\n    * R\u002FR FL (grade 1, 2 or 3a based on WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy. Patients should be considered by the investigator for all approved therapies with proven efficacy including but not limited to CAR T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Marginal zone lymphoma (MZL)\n\n    * R\u002FR extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy\n    * Active disease requiring treatment\n  * Mantle cell lymphoma (MCL)\n\n    * R\u002FR MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy\n    * Requiring treatment in the opinion of the investigator\n  * Chronic lymphocytic leukemia\u002Fsmall lymphocytic leukemia (CLL\u002FSLL)\n\n    * CLL\u002FSLL diagnosis that meets the International Workshop on CLL (International Workshop on Chronic Lymphocytic Leukemia \\[IWCLL\\]) criteria\n    * Patients with previously untreated and\u002For r\u002Fr CLL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy will be included\n    * Patients must have an indication to start treatment\n* Measurable disease, defined as:\n\n  * CLL: at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) or clonal lymphocytes measured by flow cytometry\n  * DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \\> 1.5 cm in longest diameter OR 1 extranodal lesion \\> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT\u002FMRI. For MZL, isolated splenomegaly is considered measurable for this study. For MCL, clonal lymphocytes measured by flow cytometry is considered measurable\n* Life expectancy of ≥ 6 months\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: Platelets ≥ 30,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 7g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 7 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Fridericia's formula-corrected QT interval (QTcF) ≤ 480 ms\n\n  * Note: Performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\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 90 days 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 ≤ 4 weeks of the first dose of study drug\n* Prior autologous stem cell transplant unless ≥ 30 days after transplant; or prior chimeric antigen receptor T cell (CAR-T) therapy unless ≥ 30 days after cell infusion\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* Prior therapy ≥ 2 months with or progression on a Bcl2 inhibitor (eg, venetoclax)\n* Vaccination or requirement for vaccination with a live vaccine within 35 days prior to the first dose of study drug or at any time during planned study treatment\n* Requires ongoing treatment with a strong CYP3A inducer\n* Requires ongoing treatment with warfarin or warfarin derivatives\n* Concurrent participation in another therapeutic clinical trial\n* Use of the following substances prior to the first dose of study drug:\n\n  * ≤ 28 days before first dose of study drug: Any biologic and\u002For immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, eg, rituximab, and\u002For cancer vaccine therapy)\n  * ≤ 14 days before the first dose of study drug: systemic chemotherapy or radiation therapy\n  * ≤ 7 days before the first dose of study drug: corticosteroid given with antineoplastic intent other than control of BTK inhibitor withdrawal flare\n  * ≤ 5 half-lives before the first dose of study drug: BTK inhibitor, tyrosine kinase inhibitor, or other targeted small molecule given with antineoplastic intent\n* Known current central nervous system involvement by lymphoma\u002Fleukemia\n* Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome\n* Any uncontrolled or clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction (MI) within 6 months before screening\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Unstable angina within 3 months before screening\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Severe or debilitating pulmonary disease\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Active fungal, bacterial and\u002For viral infection requiring systemic therapy\n* Underlying medical conditions that, in the investigator's opinion, will render the administration of study drugs hazardous or obscure the interpretation of toxicity or adverse events (AEs)\n* Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:\n\n  * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (\\\u003C 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation\n  * Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable\n* Any condition which in the discretion of the investigator would compromise the ability to comply with study procedures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura)\n* Females only: Pregnant or breastfeeding\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":136,"type":20},37,[88],"This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.",[140,141,142,143,144,145,146,26,147,148,149,150,151,152,153,154,27,155,156],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Recurrent Grade 1 Follicular Lymphoma","Recurrent Grade 2 Follicular Lymphoma","Recurrent Grade 3a Follicular Lymphoma","Recurrent Nodal Marginal Zone Lymphoma","Recurrent Splenic Marginal Zone Lymphoma","Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Refractory Grade 1 Follicular Lymphoma","Refractory Grade 2 Follicular Lymphoma","Refractory Grade 3a Follicular Lymphoma","Refractory Nodal Marginal Zone Lymphoma","Refractory Splenic Marginal Zone Lymphoma","2026-04-16",{"date":159,"type":32},"2026-04-20",{"date":161,"type":32},"2025-08-25",{"date":163,"type":20},"2029-01-31",{"name":99,"class":63},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":64},"100567970","phase-1-pacritinib-in-combination-with-a-btk-inhibitor-for-the-treatment-of-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-100567970","NCT06675123","Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma","A Pilot Study of Pacritinib Combined With a BTK Inhibitor in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification with a characteristic immunophenotypic profile with CD5+, CD20+, and with either cyclin D1 expression by immunohistochemistry (IHC), or positive by fluorescence in situ hybridization (FISH) or cytogenetics for the t(11,14) translocation, or both. Patients whose tumor is negative for cyclin D1 expression are allowed providing hemato-pathology confirmation of the diagnosis of MCL\n\n  * Relapsed or refractory disease after at least 1 prior line of systemic therapy\n  * Relapse must have been confirmed histologically with hematopathology review. Exceptions may be granted with study PI approval\n* Patient must be receiving treatment with single agent ibrutinib or another covalent BTK inhibitor (e.g., acalabrutinib, zanubrutinib), and must have previously achieved complete response (CR) or partial response (PR) to the BTK inhibitor, and must show evidence of progressive MCL at the time of enrollment\n* Radiographically measurable disease by Lugano criteria (e.g., one or more nodal sites of disease ≥ 1.5 cm and\u002For extranodal sites of disease ≥ 1.0 cm in longest dimension)\n\n  * If measurable bone marrow involvement or circulating disease has been confirmed in the absence of radiographically measurable disease, exceptions may be granted with study PI approval\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* WITHOUT BONE MARROW INVOLVEMENT: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* WITH BONE MARROW INVOLVEMENT: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* WITHOUT BONE MARROW INVOLVEMENT: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* WITH BONE MARROW INVOLVEMENT: Platelets ≥ 25,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 4 x upper limit of normal (ULN) (If hepatic involvement by lymphoma, or Gilbert's disease: ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 3 x ULN (If hepatic involvement by lymphoma: AST ≤ 5 x ULN)\n* Alanine aminotransferase (ALT) ≤ 3 x ULN (If hepatic involvement by lymphoma: ALT ≤ 5 x ULN)\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* IF NOT RECEIVING ANTICOAGULANTS: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* IF ON ANTICOAGULANT THERAPY: PT must be within therapeutic range of intended use of anticoagulants\n* IF NOT RECEIVING ANTICOAGULANTS: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Mean corrected QT interval (QTc) (calculated from 3 electrocardiograms using Fridericia formula) ≤ 480 ms\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 abstain from heterosexual intercourse or use a highly effective method of birth control (defined as those resulting in a failure rate of \\\u003C 1% per year) during the treatment period until at least 90 days after the last dose of pacritinib and until at least 30 days after the last dose of BTK inhibitor\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) with no identified cause other than menopause\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormone releasing intrauterine devices, and copper intrauterine devices. Note that oral contraceptives or progestin injection (e.g., Depo-Provera) alone are not considered highly effective methods of contraception on their own in combination with pacritinib; an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, or total abstinence are required\n\nExclusion Criteria:\n\n* Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy\n* Prior allogeneic stem cell transplant\n* Prior treatment with pacritinib or a janus kinase 2 (JAK2) inhibitor\n* Concomitant treatment with pirtobrutinib\n* Strong CYP3A4 inducers\u002F inhibitors within 14 days prior to day 1 of protocol therapy\n\n  * Note: Shorter washout periods may be permitted with approval of the study PI, provided that the washout period is at least five half-lives of the drug prior to day 1 of protocol therapy\n* Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤ 100 mg per day), anti-vascular endothelial growth factor (anti-VEGF) agents, and daily use of cytochrome C oxidase subunit 1 (COX-1) inhibiting non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to day 1 of protocol therapy\n* Systemic treatment with medications with arrhythmogenic potential within 14 days prior to day 1 of protocol therapy. Shorter washout periods may be permitted with approval of the study PI, provided that the washout period is at least five half-lives of the drug prior to day 1 of protocol therapy\n* Systemic steroid therapy for any cause must be tapered down to ≤ 20 mg\u002Fday prednisone or equivalent. Exceptions are:\n\n  * Use of brief (≤ 7 days) course of high dose corticosteroids (100 mg\u002Fday prednisone or equivalent) prior to initiation of study therapy for control of lymphoma-related symptoms\n  * Inhaled or topical steroids\n  * Use of mineralocorticoids for management of orthostatic hypotension\n  * Use of physiologic doses of corticosteroids for management of adrenal insufficiency\n* Significant recent bleeding history defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 within 3 months prior to day 1 of protocol therapy, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)\n* Factors that increase the risk for QT interval prolongation (eg, hypokalemia \\[defined as serum potassium \\\u003C 3.0 mEq\u002FL that is persistent and refractory to correction\\], or history of long QT interval syndrome)\n* Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 3 months of screening, any class III or IV cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or any class C or D cardiac disease as defined by the NYHA Objective Assessment\n\n  * Note: Subjects with controlled, asymptomatic atrial fibrillation\u002Fflutter can enroll on study\n* Inability to swallow and retain an oral medication\n* Any active gastro-intestinal or metabolic condition that could significantly interfere with absorption of oral medication\n* Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation\n* Known hypersensitivity to compounds of similar chemical composition to study agent or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate, or to loperamide or equivalent antidiarrheal medication\n* Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement\n* Known history of progressive multifocal leukoencephalopathy (PML)\n* Prior or concurrent malignancy whose natural history or treatment could interfere with the safety or efficacy assessment of the protocol therapy\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to day 1 of protocol therapy\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing to be done only in patients suspected of having infections or exposures. Patients with history of HBV infection (defined as negative hepatitis B surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV RNA (PCR testing only required if HCV antibody testing is positive).\n* Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \\> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures\n* FEMALES ONLY: Pregnant or breastfeeding\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":173,"type":20},10,[88],"This phase I trial tests the safety and side effects of pacritinib in combination with a Bruton's tyrosine kinase (BTK) inhibitor and how well it works 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). Pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. BTK inhibitors block a protein called BTK which is present on B-cell (a type of white blood cell) cancers such as mantle cell lymphoma at abnormal levels. This may help keep tumor cells from growing and spreading. Giving pacritinib in combination with a BTK inhibitor may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma.",[26,27],"2026-04-01",{"date":179,"type":32},"2026-04-07",{"date":181,"type":20},"2026-06-01",{"date":183,"type":20},"2028-03-08",{"name":99,"class":63},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":64},"100472496","phase-1-genetically-modified-t-cells-cmv-specific-cd19-car-t-cells-plus-a-vaccine-cmv-mva-triplex-following-stem-cell-transplantation-for-the-treatment-of-intermediate-or-high-grade-b-cell-non-hodgkin-lymphoma-100472496","NCT05432635","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","Pilot\u002FFeasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)","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 PI approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limits of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are =\\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Left ventricular ejection fraction \\>= 45 percent within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\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 6 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* Prior autologous\u002Fallogeneic stem cell transplant\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg \u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to myeloablative HSCT per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cells \\[WBC\\] \u002F mm\\^3 and no blasts in cerebrospinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years.\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Procedures (including compliance issues related to feasibility\u002Flogistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study\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":193,"type":20},15,[88],"This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are 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 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. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.",[197,198,113,199,142,26,200,201],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Transformed Non-Hodgkin Lymphoma","2026-02-20",{"date":204,"type":32},"2026-02-23",{"date":206,"type":32},"2023-08-01",{"date":208,"type":20},"2028-12-30",{"name":99,"class":63},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":64},"100530830","phase-1-b-cell-activating-factor-receptor-baffr-based-chimeric-antigen-receptor-t-cells-with-fludarabine-and-cyclophosphamide-lymphodepletion-for-the-treatment-of-relapsed-or-refractory-b-cell-hematologic-malignancies-100530830","NCT06191887","B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies","Phase 1a\u002F1b Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells (MC10029) in Subjects With Relapsed or Refractory BAFFR-Expressing B-Cell Hematologic Malignancies","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL\u002FSLL\n\n  * For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:\n\n    * Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria\n    * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by PET\u002FCT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma\n* PRE-REGISTRATION: Disease Specific prior lines of therapies below:\n\n  * For CLL\u002FSLL, patients must have received ≥ two prior lines of therapy, and\u002For ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months\n\n    * These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).\n  * For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.\n  * For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator.\n\n    * NOTE: Prior failed CD19 directed CART must have a 100-day washout period\n  * For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.\n  * 100-day washout period starts from the date of the last prior CAR-T infusion.\n* PRE-REGISTRATION: Measurable disease\n* REGISTRATION: Positive BAFFR test\n* REGISTRATION: Measurable disease\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* REGISTRATION: Hemoglobin ≥ 9.0 g\u002FdL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Platelet count ≥100,000\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration\n* REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration\n* REGISTRATION: Prothrombin time (PT)\u002Finternational normalized ratio (INR) \u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration\n\n  * Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT\u002FINR measurements \\> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study\n* REGISTRATION: Calculated creatinine clearance ≥45 ml\u002Fmin using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures\n* REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%\n* REGISTRATION: Patients must have pulse ox measurements of \\> 92% on room air\n* REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for study follow-up\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Prior solid organ transplantation\n* PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration\n* PRE-REGISTRATION: Prior anti-BAFF-R therapies\n* PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy\n* PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration\n* PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R\n* PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration\n* PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Previous or concurrent malignancy\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 \\* Persons of childbearing potential who are pregnant or breastfeeding\n  * Life Expectancy of \\\u003C 6 weeks\n  * Persons requiring systemic corticosteroids (\\>10 mg prednisone or equivalent per day) and\u002For other immunosuppressive therapy. Patients are allowed to use topical corticosteroids\n  * Any other conditions that would limit compliance with study requirements\n* PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by malignancy (CSF or imaging) with still active disease. Note: Patients with a history of CNS involvement resolving after treatment and without active disease will be considered eligible if other inclusion criteria are met\n* PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration\n* PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT\n* PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients\n* PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure\n* REGISTRATION: Eligible for auto-HCT based on investigator judgement\n* REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment\n* REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility\n* REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration\n* REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding\n* REGISTRATION: Life expectancy of \\\u003C 6 weeks",{"count":218,"type":20},27,[88],"This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells 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. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.",[197,114,142,222,26,223,115,224,116,150,225,27,226,117,227],"Recurrent Follicular Lymphoma","Recurrent Marginal Zone Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","2026-02-11",{"date":230,"type":32},"2026-02-13",{"date":232,"type":32},"2024-03-18",{"date":234,"type":20},"2040-12-31",{"name":236,"class":63},"Mayo Clinic",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":64},"100399652","phase-2-modified-immune-cells-cd19-car-t-cells-and-acalabrutinib-for-the-treatment-of-relapsed-or-refractory-mantle-cell-lymphoma-100399652","NCT04484012","Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma","A Phase 2 Study to Evaluate CD19-Specific Chimeric Antigen Receptor (CAR)-T Cells Combined With Acalabrutinib for Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)","Inclusion Criteria Informed Consent and Willingness to Participate\n\n1. All participants must have the ability to understand and the willingness to sign a written informed consent.\n2. Participants must agree to allow the use of archival tissue from diagnostic tumor biopsies.\n\n   * If unavailable, exceptions may be granted with Study PI approval. Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed.\n\n   Age Criteria\n3. Age 18 years and older. Performance Status\n4. ECOG Performance status ≤ 2 or KPS ≥ 70% (Appendix A) Nature of Illness and Treatment-Related Criteria\n5. Documented CD19+ MCL by flow cytometry or IHC (from biopsy) if prior CD19 directed therapy was previously used\n\n   a. BM is optional at enrollment IF patient already has biopsy proven disease.\n6. Participants must be currently receiving acalabrutinib and have been taking acalabrutinib for between 3 and 7 months prior to initiating screening procedures on the study and:\n\n   1. must have at least 1 prior regimen (not including single-agent corticosteroids)\n   2. best response to acalabrutinib therapy is MRD+ CR, PR or SD at the time of screening b (1) must have measurable disease by CT scan (≥ 1.5 cm) or evidence of blood, spleen, skin, gastrointestinal (GI) or bone marrow involvement Note: Participants who are on other BTK inhibitors, but will thereafter be switched to acalabrutinib prior to lymphodepletion, may be eligible provided that the duration of all BTK inhibitor therapy was ≤ 3-7 months\n7. No contraindications to leukapheresis, steroids or tocilizumab Clinical Laboratory Criteria (To be performed within 28 days prior to enrollment)\n8. Total serum bilirubin ≤ 2.0 mg\u002FdL Participants with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.\n9. Blood counts:\n\n   * Absolute Neutrophil count (ANC ≥1000 cells\u002Ful)\\*\n\n     * Growth factor use within 7 days prior screening is not allowed\n   * Platelet count ≥75,000\u002Ful. Transfusion with 7 days prior to screening is not allowed\\* \\*Exception: participants with bone marrow involvement do not need to meet this criteria\n10. AST \\\u003C 3 x ULN\n11. ALT \\\u003C 3 x ULN\n12. Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n13. International Normalized Ratio (INR) OR Prothrombin (PT) ≤ 1.5 x ULN\n14. Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN\n15. Female of childbearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n16. Cardiac function (12 lead-ECG): QTc must be ≤ 480 msec\n17. Left ventricular ejection fraction \\>40%\n18. Oxygen saturation 92% or above at room air or DLCO of 40% of best predicted Contraception\n19. Participants of reproductive potential must agree to use highly effective birth control methods throughout therapy and for 2 months after final CAR T cell infusion and\u002For 2 days after final acalabrutinib dose, whichever is later (See Section 5.12 and Appendix B).\n\nExclusion Criteria Previous therapies\n\n1. Allogeneic hematopoietic cell transplantation (HCT) within the last 6 months.\n2. Autologous HCT within the last 3 months.\n3. Prior failure of any BTK inhibitor therapy. (Participant WILL be allowed if, after administration of other BTK inhibitors they have switched to acalabrutinib prior to lymphodepletion, and if the duration of all BTK inhibitor therapy was ≤ 3-7 months).\n4. Participants known to have mutations associated with resistance to BTK inhibitors from prior studies.\n\n   Concomitant therapies\n5. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (i.e., prednisone ≤ 7.5 mg \u002Fday, or hydrocortisone ≤ 20 mg \u002Fday) is allowed. During study participation, participants may receive systemic corticosteroids as needed for treatment-emergent comorbid conditions.\n6. Approved anti-cancer therapies other than acalabrutinib are not allowed after enrollment, with the exception of steroids or involved field radiation to control progressive disease during cell manufacturing, prior to lymphodepletion\u002Fstart of protocol therapy.\n7. Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer.\n8. Unable to discontinue anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of leukapheresis and remain off through end of study treatment.\n\n   Other illnesses or conditions\n9. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll.\n10. Participants with clinically significant arrhythmia or arrhythmias not stable on medical management.\n11. Active auto-immune disease requiring systemic immunosuppressive therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).\n12. Suspected or confirmed progressive multifocal leukoencephalopathy (PML).\n13. Requires major surgical procedure within 28 days prior to first dose of study drug. If a subject has major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n14. Participants with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.\n15. Known history of drug-specific hypersensitivity or anaphylaxis to either study agent.\n16. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.\n17. Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)\n18. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n19. History of other malignancies, except for the following: malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; early stage prostate cancer on expectant management; malignancy treated with curative intent with no known active disease present for ≥ 3 years.\n20. Lactating women.\n21. Active chronic graft-versus-host disease (GVHD) post-allogeneic HCT.\n22. Uncontrolled active infection:\n\n    * HIV positive or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment.\n    * Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded.\n    * Subjects who are hepatitis B core antibody positive (or have a known history of HBV infection) should be monitored quarterly with a quantitative PCR test for HBV DNA. HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core Ab positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment.\n    * Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.\n    * Subjects who are positive cytomegalovirus \\[CMV\\] DNA polymerase chain reaction \\[PCR\\]).\n    * Subject with any active significant bacterial, fungal or viral (other than those listed) infections.\n23. Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n\n    Noncompliance\n24. 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).\n\n    * Eligibility should be confirmed per institutional policies.","75 Years",{"count":246,"type":20},36,[23],"This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.",[26,27],"2025-11-24",{"date":252,"type":32},"2025-11-26",{"date":254,"type":32},"2020-12-31",{"date":256,"type":20},"2026-09-02",{"name":99,"class":63},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"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":267,"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.",[26,27],"2024-11-14",{"date":273,"type":32},"2024-11-18",{"date":275,"type":32},"2024-01-04",{"date":277,"type":20},"2030-12-30",{"name":279,"class":63},"Academic and Community Cancer Research United",2]