[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-lymphoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,51,81,106,133,156,179,198,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100429351","phase-1-cbl0137-for-the-treatment-of-relapsed-or-refractory-solid-tumors-including-cns-tumors-and-lymphoma-100429351",false,"NCT04870944","CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma","A Phase 1\u002F2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma","Inclusion Criteria:\n\n* Parts A and B: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n\n  * Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible\n  * Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy\n* Part A: Patients must have either measurable or evaluable disease\n* Part B: Patients must have measurable disease\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age. Patients must have a Karnofsky or Lansky score \\>= 50%\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy \\[XRT\\]\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to CBL0137\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fsex as follows (performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n  * 1 to \\\u003C 2 years: 0.6 (male); 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male); 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male); 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male); 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male); 1.4 (female)\n  * \\>= 16 years: 1.7 (male); 1.4 (female)\n* Patients with solid tumors:\n\n  * Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with solid tumors:\n\n  * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (performed within 7 days prior to enrollment unless otherwise indicated)\n* Shortening fraction of \\>= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated) or\n* Ejection fraction of \\>= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)\n* Corrected QT (QTC) \\\u003C 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy\n* Patients who are receiving drugs associated with a known risk of Torsades de Pointes (TdP) are not eligible. Drugs associated with known risk of Torsades de Pointes (TdP) are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy\n* Patients with known peripheral vascular disease are excluded\n* Patients with a history of pro-thrombotic disorder are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","ALL","12 Months","21 Years",{"count":20,"type":21},63,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase I\u002FII trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.",[28,29,30,31,32,33,34,35,36,37],"Diffuse Midline Glioma, H3 K27-Altered","Metastatic Malignant Neoplasm in the Central Nervous System","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27-Altered","Recurrent Lymphoma","Recurrent Malignant Solid Neoplasm","Recurrent Primary Malignant Central Nervous System Neoplasm","Refractory Lymphoma","Refractory Malignant Solid Neoplasm","Refractory Primary Malignant Central Nervous System Neoplasm","RECRUITING","2026-05-01",{"date":41,"type":42},"2026-05-05","ACTUAL",{"date":44,"type":42},"2022-01-28",{"date":46,"type":21},"2026-12-31",{"name":48,"class":49},"Children's Oncology Group","NETWORK",35,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100317852","phase-2-ascorbic-acid-and-chemotherapy-for-the-treatment-of-relapsed-or-refractory-lymphoma-ccus-and-chronic-myelomonocytic-leukemia-100317852","NCT03418038","Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia","Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed\u002F Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted \\> 6 months; refractory is no response or relapse within 6 months; previous biopsies \\\u003C 6 months prior to treatment on this protocol will be acceptable\n\n  * NOTE: Arms A\u002FB - relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\n  * NOTE: Arm C patients include relapsed or refractory lymphoma patients of any type for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed or refractory double-hit high grade lymphoma patients and relapsed or refractory Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding\n* Measurable or assessable disease: measurable disease is defined as measurable by computed tomography (CT) \\[dedicated CT or the CT portion of a positron emission tomography (PET)\u002FCT\\] or magnetic resonance imaging (MRI): to be considered measurable, there must be at least one lesion that has a single diameter of \\>= 1.5 cm\n\n  * NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler; patients with assessable disease by PET are also eligible as long as the assessable disease is biopsy proven lymphoma\n* Arms A\u002FB - eligible for treatment with ifosfamide, carboplatin, and etoposide (+\u002F- rituximab)\n* Arm C eligible for treatment with one of the following standard, every 3 week, platinum-based salvage regimens (with or without monoclonal antibody as appropriate for the disease):\n\n  * Ifosfamide\u002Fcarboplatin\u002Fetoposide (ICE) or rituximab\u002Fifosfamide\u002Fcarboplatin\u002Fetoposide (RICE);\n  * Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or RDHAP;\n  * Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);\n  * Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);\n  * Oxaliplatin, cytosine arabinoside, dexamethasone (OAD) or rituximab, oxaliplatin, cytosine arabinoside, dexamethasone (ROAD)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\>= 8.0 g\u002FdL (may transfuse to meet this requirement), obtained =\\\u003C 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Platelet count \\>= 75000\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN), obtained =\\\u003C 14 days prior to registration\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement), obtained =\\\u003C 14 days prior to registration\n* Creatinine =\\\u003C 1.6 mg\u002FdL; if over 1.6 then the calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula, obtained =\\\u003C 7 days prior to registration\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) test done =\\\u003C 14 days prior to registration\n\n  * If positive, the CD4 count must be \\> 400\n* Provide written informed consent\n* Willingness to have a central venous line \\[peripherally inserted central catheter (PICC) or PORT\\]\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM D: Patients who had a diagnosis of CCUS with one or more TET2 mutations or TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2) or epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2). CCUS diagnosis being defined based on the absence of definitive morphologic evidence of hematologic neoplasms from bone marrow biopsy evaluation combined with evidence of pathogenic myeloid somatic mutation with a variant allele frequency (VAF) of at least 2% using our institution's next generation sequencing (NGS) panel (OncoHeme, Mayo Clinic)\n* ARM D: ECOG performance status (PS) 0, 1 or 2\n* ARM D: Patients must meet at least 1 of these 3 laboratory criteria to be enrolled:\n\n  * Hemoglobin =\\\u003C 10g\u002FdL (obtained =\\\u003C 7 days prior to registration)\n  * Absolute neutrophil count (ANC) =\\\u003C 1000\u002Fmm\\^3 (obtained =\\\u003C 7 days prior to registration)\n  * Platelet count =\\\u003C 100,000\u002Fmm\\^ 3 (obtained =\\\u003C 7 days prior to registration)\n* ARM D: Total bilirubin =\\\u003C 2 x ULN (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Creatinine =\\\u003C 1.6 mg\u002FdL (obtained =\\\u003C7 days prior to registration). If \\> 1.6, then the Calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM D: Negative pregnancy test, for persons of childbearing potential only (obtained =\\\u003C 7 days prior to registration). NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* ARM D: Provide written informed consent\n* ARM D: Willingness to have a central venous line (PICC or PORT)\n* ARM D: Willingness to provide mandatory blood specimens for correlative research\n* ARM D: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM D: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM E PRE-REGISTRATION: Age ≥ 18 years\n* ARM E PRE-REGISTRATION: New or an established diagnosis of 2016 World Health Organization (WHO) defined chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation requiring treatment with DNA methyltransferase inhibitors\u002Fhypomethylating agents\n* ARM E PRE-REGISTRATION: No prior CMML directed therapy.\n\n  * Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. NOTE: Prior exposure to hydroxyurea is allowed. Continuation beyond the first cycle must be discussed with the principal investigator (PI)\n* ARM E PRE-REGISTRATION: Creatinine ≤ 1.6 mg\u002FdL. If \\> 1.6, then the Calculated creatinine clearance must be ≥ 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM E PRE-REGISTRATION: Willingness to provide mandatory research bone marrow sample for correlative research\n* ARM E PRE-REGISTRATION: ECOG performance status (PS) 0, 1, or 2\n* ARM E PRE-REGISTRATION: Provide written informed consent\n* ARM E REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* ARM E REGISTRATION: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM E REGISTRATION: Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* ARM E REGISTRATION: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Platelet count ≥ 20,000\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Total bilirubin ≤ 1.5 x ULN ( ≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Ability to complete questionnaire by themselves or with assistance\n* ARM E REGISTRATION: For a person of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study. Adequate contraception is defined as follows:\n\n  * Complete true abstinence\n  * Consistent and correct use of one of the following methods of birth control:\n\n    * Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient\n    * Implants of levonorgestrel\n    * Injectable progestogen\n    * Intrauterine device (IUD) with a documented failure rate of less than 1% per year\n    * Oral contraceptive pill (either combined or progesterone only)\n    * Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen\n* ARM E REGISTRATION: WOCBP must have a negative serum or urine pregnancy test ≤ 7 days prior to registration. NOTE: WOCBP include any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\> 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL. Even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* ARM E REGISTRATION: Persons who are able to father a child must use contraception during the study and for 3 months after the last treatment dose.\n\n  * Complete true abstinence\n  * Latex condom with a spermicidal agent\n  * Diaphragm with spermicide\n* ARM E REGISTRATION: Willingness to have a central venous line (PICC or PORT)\n* ARM E REGISTRATION: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any therapy =\\\u003C 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretion. Exception: Palliative radiation is allowed\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the lymphoma\n* Other active malignancy than lymphoma\n\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer that could interfere with this protocol therapy; patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria; patients with non-melanotic skin cancer may enroll\n* History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* Patients with active central nervous system (CNS) lymphoma or active cerebrospinal fluid (CSF) involvement with malignant cells requiring CNS-specific therapy with IV or intrathecal (IT) methotrexate (MTX); Note: Patients with any prior CNS lymphoma (parenchymal or leptomeningeal) MUST be in complete remission (CR) in those compartments without any maintenance therapy required\n* Patients with uncontrolled or symptomatic kidney stones\n* Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Bona-fide hematological neoplasm\n* ARM D: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* ARM D: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM D: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM D: History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM D: Patients with uncontrolled or symptomatic kidney stones\n* ARM D: Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E PRE-REGISTRATION: Myelodysplastic syndrome (MDS)\u002Fmyeloproliferative neoplasm (MPN) overlap syndromes other than CMML\n* ARM E PRE-REGISTRATION: Active central nervous system disease\n* ARM E PRE-REGISTRATION: Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* ARM E PRE-REGISTRATION: Concurrent active malignancy, except adequately treated nonmelanoma skin cancer. History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for \\> 2 years\n* ARM E PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM E PRE-REGISTRATION: Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of ≥ 20 mg\u002Fday prednisone (or equivalent). Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids\n* ARM E PRE-REGISTRATION: Patients with uncontrolled or symptomatic kidney stones\n* ARM E REGISTRATION: New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* ARM E REGISTRATION: History of myocardial infarction ≤ 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM E REGISTRATION: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac arrhythmia, unstable angina pectoris, clinically significant nonhealing or healing wounds, pulmonary congestion or pulmonary edema, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, clinical dehydration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM E REGISTRATION: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception","18 Years",{"count":60,"type":21},80,[25],"This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.\n\nArms A, B, C, and D are closed to enrollment.",[64,65,66,67,32,68,35,69],"Clonal Cytopenia of Undetermined Significance","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Chronic Myelomonocytic Leukemia","2026-04-13",{"date":72,"type":42},"2026-04-16",{"date":74,"type":42},"2018-03-23",{"date":76,"type":21},"2033-11-02",{"name":78,"class":79},"Mayo Clinic","OTHER",4,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100583341","phase-1-gb5005-cart-cell-injection-in-the-treatment-of-patients-with-cd19-positive-rr-b-nhl-100583341","NCT06875063","GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL","The Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of GB5005 Chimeric Antigen Receptor T-cell Injection in Treating Patients With CD19-positive Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL).","Inclusion Criteria:\n\n1. The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;\n2. Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;\n3. Non Hodgkin lymphoma confirmed by cytology and genetics;\n4. Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;\n5. When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment; Or recurrent patients who do not fully meet the above conditions but refuse chemotherapy and strongly demand CAR-T treatment;\n6. There is no obvious evidence of central nervous system lymphoma on brain MRI;\n7. Blood routine: Neutrophils ≥ 1.0 × 10 \\^ 9\u002FL; Hemoglobin ≥ 70 g\u002FL; Platelets ≥ 50 × 10 \\^ 9\u002FL;\n8. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; Activated partial thromboplastin time (APTT) ≤ ULN+10 s, prothrombin time (PT) ≤ ULN+3 s;\n9. Liver and kidney function indicators: total bilirubin ≤ 1.5 times the upper limit of normal range (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0 times the upper limit of normal range (ULN), serum creatinine ≤ 2.0 times the upper limit of normal range. If the above abnormalities are considered to be caused by tumor infiltration, they can be excluded;\n10. Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA). (After corrective treatment and meeting the criteria, it can be included in the group);\n11. Pulmonary function: Dyspnea ≤ CTCAE level 1 and SaO2 ≥ 92% in indoor air environment; 12. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points;\n12. Expected survival is greater than 6 months; 14. The subjects have sufficient levels of functional organs during screening;\n13. Female participants of childbearing age must undergo a serum pregnancy test during screening and before receiving pre-treatment chemotherapy, and the result must be negative. They are willing to use highly effective and reliable methods of contraception within one year after using the study treatment;\n14. Male participants who engage in active sexual activity with women with reproductive potential must be willing to use highly effective and reliable methods of contraception within one year after using the study treatment. Moreover, all males are strictly prohibited from donating sperm within one year after receiving research treatment infusion during the study period.\n\nExclusion Criteria:\n\n1. Patients with a history of allergies to serum albumin and DMSO in the past;\n2. Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;\n3. Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;\n4. History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;\n5. Primary central nervous system tumors or hematological tumors with central nervous system metastases;\n6. Uncontrolled mental illness;\n7. Merge other life-threatening severe organ failure;\n8. Participated in other clinical studies within 4 weeks;\n9. Received live vaccination within 4 weeks of enrollment;\n10. Using prohibited drugs: a. Hormones: Corticosteroids (defined as\\>20mg\u002Fday prednisone or equivalent) used at therapeutic doses within 7 days prior to leukocyte collection. But the use of physiological substitutes, local and inhaled steroids is allowed. b. Chemotherapy: rescue chemotherapy, including tyrosine kinase inhibitors (TKIs), received within 1 week before leukocyte collection. c. Donor lymphocyte infusion (DLI) received within 4 weeks before leukocyte collection. d. graft-versus-host disease (GvHD) treatment: systemic anti GVHD treatment received within 3 months before GB5005 cell infusion. e. Alenumab used within 6 months before leukocyte collection, or chlorofarabin or cladribin used within 3 months. f. Checkpoint inhibitors or stimulants used before enrollment (excluding those with more than 3 biological half lives);\n11. Patients with known history of lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment;\n12. Women who are already pregnant, preparing for pregnancy during the trial period, or breastfeeding;\n\n13：As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated in the protocol (including the follow-up period) or has insufficient compliance with the study.","70 Years",{"count":90,"type":21},45,[24],"To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (B-NHL).",[94,35,95],"Non-hodgkin Lymphoma","Chimeric Antigen Receptor T-cell","2026-03-11",{"date":98,"type":42},"2026-03-13",{"date":100,"type":21},"2026-04-30",{"date":102,"type":21},"2027-05-31",{"name":104,"class":79},"The First Affiliated Hospital of Xiamen University",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":122,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100559397","phase-2-epco-zanu-ritux-for-rr-fl-or-mzl-100559397","NCT06563596","Epco, Zanu, Ritux for R\u002FR FL or MZL","A Phase 2 Study of Epcoritamab, Zanubrutinib, and Rituximab (EZR) for Treatment of Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current histologic transformation are excluded.\n* Receipt of at least one prior line of therapy for FL or MZL (with prior treatment including a CD20 monoclonal antibody).\n* Measurable disease, defined as ≥1 measurable nodal lesion (long axis \\>1.5 cm or short axis \\>1.0 cm), or ≥1 measurable extra-nodal lesion (long axis \\>1.0 cm), or spleen \\>13 cm on PET, CT, or magnetic resonance imaging (MRI). For patients with FL, disease should be FDG-avid based on PET. FDG-avid disease is NOT a requirement for patients with MZL.\n* Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:\n\n  * Symptomatic adenopathy\n  * Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \\\u003C1.5x109\u002FL; absolute neutrophil count \\[ANC\\] \\\u003C1.0x109\u002FL, Hgb \\\u003C10g\u002FdL; or platelets \\\u003C100x109\u002FL)\n  * Constitutional symptoms (defined as persistent fevers \\>100.4 F, shaking chills, drenching night sweats, or loss of \\>10% of body weight within 6 months)\n  * Any nodal or extranodal tumor mass \\>7 cm in maximum diameter\n  * \\>3 nodal sites of involvement \\>3 cm\n  * Local compressive symptoms or imminent risk thereof\n  * Splenomegaly (craniocaudal diameter \\> 16cm on CT imaging)\n  * Clinically significant pleural or peritoneal effusion\n  * Leukemic phase (\\>5x109\u002FL circulating malignant cells)\n  * Rapid generalized disease progression\n  * Renal infiltration\n  * Bone lesions\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)\n* Age ≥18 years.\n* Adequate hematologic and organ function:\n\n  1. Absolute neutrophil count \\> 1.0x109\u002FL unless due to marrow involvement by lymphoma in which case ANC must be \\>0.5x109\u002FL\n  2. Platelets \\> 75 x109\u002FL, unless due to marrow involvement by lymphoma, in which case platelets must be \\>50 x109\u002FL\n  3. Estimated CrCl (based on Cockcroft Gault or MDRD) ≥ 45ml\u002Fmin or ≥ 45ml\u002Fmin\u002F1.73m2\n  4. Total bilirubin \\\u003C 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be \\\u003C 1.5 x ULN\n  5. AST\u002FALT \\\u003C 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST\u002FALT must be \\\u003C5 x ULN\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if it is collected within 90 days and without intervening treatment and the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively-charged glass slides. Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Sponsor-Investigator.\n* Willingness to remain abstinent (1) or to use two effective contraceptive methods that result in a failure rate of \\\u003C1% per year from screening until: (a) at least 12 months after pre-treatment with rituximab, 12 months after the last dose of epcoritamab, or 3 months after the last dose of zanubrutinib, whichever is longer, if the patient is a male or (b) until at least 12 months after pre-treatment with rituximab, 12 months after the last dose of epcoritamab, or 3 months after the last dose of zanubrutinib, whichever is longer, if patient is a female. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include:\n\n  * Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of \\\u003C1% per year. Barrier methods must always be supplemented with the use of a spermicide.\n\n    1. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. In contrast, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of \\>10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for lymphoma-related symptom palliation or for prophylaxis (i.e., IV contrast allergy) is allowed, in which case patients should be off steroids prior to treatment start.\n* Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.\n* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n* Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA must have a sensitivity of \\\u003C 15 IU\u002FmL). Subjects who received treatment for HCV that was intended to eradicate the virus and who have an undetectable HCV RNA may participate without serial HCV RNA screening. Other patients may participate if they are willing to undergo every 3-month monitoring for HCV reactivation.\n* Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with positive hepatitis B serologies with undetectable HBV DNA (NOTE: the limit of detection for HBV DNA must have a sensitivity of \\\u003C 20 IU\u002FmL) are permitted in the trial but should receive prophylactic antiviral therapy (i.e. entecavir) and undergo every 3 month HBV DNA monitoring.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring antimicrobial therapy at trial enrolment or significant infections within 2 weeks of study treatment initiation.\n* Subject has a known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or has had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n  * No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n  * Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n* Prior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or Gleason 6 prostate cancer managed with observation) unless disease free for at least 2 years OR unless the likelihood of relapse is very low in the opinion of the treating physician.\n* Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period. Vaccination with live vaccines within 28 days of the first dose of study treatment is prohibited.\n* Patients who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.\n* Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary\u002Fperipheral artery bypass graft, cardiac arrhythmia (CTCAE grade 3 or higher), or cerebrovascular accident. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. Uncontrolled hypertension as indicated by ≥ 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mm Hg and diastolic blood pressure \\> 105 mm Hg at screening.\n* Patients with 1) New York Heart Association Class III or IV heart failure or known ejection fraction of \\\u003C45%, 2) MI within 6 months prior to screening, 3) unstable angina within 3 months before screening, or 4) history of clinically significant arrhythmias within 6 months of screening (eg sustained Vtach, Vfib, torsades de pointes).\n* Inability to comply with protocol mandated restrictions.\n* Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.\n* Prior solid organ or allogeneic stem cell transplantation.\n* History of known or suspected hemophagocytic lymphohistiocytosis (HLH).\n* History of clinically significant autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  • Patients with a remote history of, or well controlled, autoimmune disease who meet above criteria may be eligible to enroll after consultation with the Sponsor-Investigator.\n* Inability to tolerate anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.\n* Known central nervous system involvement\n* Neuropathy \\> grade 1(based on CTCAE grading)\n* Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab.\n* Treatment with an investigational drug within 4 weeks prior to the first dose of study treatment.\n* Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks prior to the first dose of study treatment.\n* Participants who require warfarin or other vitamin K antagonists for anticoagulation. Other anticoagulants including direct oral anticoagulants (i.e. apixaban, rivaroxaban) and low-molecular weight heparin are allowed.\n* Participants who are known at the time of study entry to require concomitant treatment with any medications or substances that are strong CYP3A inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome.\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusions or other medical interventions. Requires ongoing treatment with warfarin or warfarin derivatives.\n* Prior exposure to a BTK inhibitor\n* A limited number of patients with BsAb-refractory disease will be permitted to enroll in each cohort (see section 2.5.3). After this limit is reached, patients with BsAb-refractory disease will be excluded. BsAb-refractory disease will be defined as failing to achieve an objective response to a prior CD3xCD20 BsAb or relapse\u002Fprogression within 6 months of last dose of CD3xCD20 BsAb.\n* Screening 12-lead ECG showing a baseline QTcF (Fridericia's correction) \\> 480 msec.\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n* Major surgery ≤ 4 weeks before the first dose of study treatment or planned during study.",{"count":90,"type":21},[25],"The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL).\n\n* The names of the study drugs involved in this research study are:\n* Epcoritamab (a type of antibody)\n* Zanubrutinib (a type of Bruton tyrosine kinase inhibitor)\n* Rituximab (a type of monoclonal antibody)",[117,118,119,120,35,121],"Follicular Lymphoma","Lymphoma","Non-Hodgkin Lymphoma","Relapsed Lymphoma","Marginal Zone Lymphoma",[117,118,119,120,35,121],"2026-02-17",{"date":125,"type":42},"2026-02-19",{"date":127,"type":42},"2025-01-21",{"date":129,"type":21},"2030-03-01",{"name":131,"class":79},"Reid Merryman, MD",3,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":132},"100428181","phase-1-avo-in-rr-and-previously-untreated-mcl-100428181","NCT04855695","Avo In R\u002FR And Previously Untreated MCL","A Phase 1\u002F2 Study of Acalabrutinib, Venetoclax, and Obinutuzumab in Patients With Relapsed\u002FRefractory and Previously Untreated Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Participants must meet the following criteria on screening examination to be eligible to participate in the study:\n* Participants must have histologically determined mantle cell lymphoma with pathologic review at the participating institutions, that has either:\n\n  * Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A) or; Had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (parts B, C, and D).\n  * Participants in part A, relapsed or refractory following prior therapy, may have had a prior autologous or allogeneic stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).\n* Participants in parts B, C, and D, without prior anti-lymphoma therapy, must require treatment as defined by any of the following criteria:\n\n  * Symptomatic adenopathy or splenomegaly\n  * Local symptoms due to extranodal disease\n  * Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \\\u003C1.5x109\u002FL; absolute neutrophil count \\[ANC\\] \\\u003C1.0x109\u002FL, Hgb \\\u003C10g\u002FdL; platelets \\\u003C100x109\u002FL)\n  * Presence of systemic B symptoms (fever, drenching night sweats, or unintentional weight loss ≥ 10% body weight over previous 6 months) or functionally significant fatigue\n* Participants in part B without prior anti-lymphoma therapy should be deemed to be ineligible for autologous stem cell transplant by the treating physician and\u002For have a TP53 mutation detected by next generation sequencing at a variant (mutant) allele fraction above the validated threshold for calling a new variant or high TP53 expression on immunohistochemistry (\\>50% positive lymphoma cells)\n* Participants in part C without prior anti-lymphoma therapy should be deemed to be eligible for autologous stem cell transplant by the treatment physician and have no evidence of TP53 mutation (TP53 wild type) detected by next generation sequencing and no evidence of high TP53 expression on immunohistochemisty\n* Participants in part D without prior anti-lymphoma therapy must have a TP53 mutationdetected by next generation sequencing at a variant (mutant) allele fraction above thevalidated threshold for calling a new variant\n* Participants in parts B, C, and D must have an archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy and peripheral blood available for submission to Adaptive Biotechnologies for ClonoSEQ®ID molecular marker identification of a unique clonal immunoglobulin DNA sequence. Only those participants in parts B and C who have a molecular marker identified from the peripheral blood will be eligible for minimal residual disease (MRD) driven treatment interruptions.\n* Participants in parts B, C, and D who do not have a molecular marker identified by ClonoSEQ from the peripheral blood will be deemed to be MRD indeterminate and are not eligible for peripheral blood MRD driven treatment interruptions. These participants will be able to enroll in the study assuming all other eligibility criteria are met but will receive 7 cycles of AVO combination therapy followed by 17 cycles of acalabrutinib and venetoclax therapy (24 total cycles of AV) and 2 years of maintenance obinutuzumab for a total of 31 cycles of therapy.\n* Measurable disease with a lymph node or tumor mass ≥ 1.5 cm in at least one dimension by CT, PET\u002FCT, or MRI. Patients without measurable disease will be eligible if they have marrow involvement and cytopenias related to their lymphoma (hemoglobin \\\u003C10 g\u002FdL, absolute neutrophil count \\\u003C 1.0 x 109\u002FL, or platelets \\\u003C 100 x 109\u002FL) OR symptomatic splenomegaly \\> 15cm in craniocaudal diameter.\n* Age ≥ 18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 750 cells\u002Fmm3 (0.75 x109\u002FL) unless due to marrow involvement by lymphoma in which case ANC must be ≥ 500 cells\u002Fmm3 (0.5x109\u002FL)\n  * Platelet count without transfusional support must be ≥ 75,000 cells\u002Fmm3 (75 x109\u002FL), unless due to marrow involvement by lymphoma, in which case platelets must be ≥ 50,000 cells\u002Fmm3 (50 x109\u002FL)\n  * Hemoglobin without transfusional support must be ≥ 8.0 g\u002FdL (80 g\u002FL) unless due to marrow involvement by lymphoma, in which case hemoglobin must be ≥ 7.0 g\u002FdL (70 g\u002FL)\n  * Creatinine clearance (CrCl) ≥ 50 ml\u002Fmin using 24-hour urine collection for creatinine clearance or calculated CrCl or calculated glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m2 using the CKD-EPI equation\n  * Total bilirubin ≤ 2 times the upper limit of normal, unless there is disease involvement of the liver, hemolysis, or a known history of Gilbert's disease, in which case direct bilirubin must be ≤ 3 times the upper limit of normal\n  * AST and ALT ≤ 2.5 times the upper limit of normal, unless documented liver involvement by lymphoma, in which case AST and ALT must be ≤ 5 times the upper limit of normal\n  * PT\u002FINR ≤ 2 times the upper limit of normal and PTT ≤ 2 times the upper limit of normal\n* Willingness to provide pre-treatment bone marrow (or recent archival w\u002Fo intervening therapy) and on-treatment bone marrow and peripheral blood samples\n* The effects of the study drugs on the developing human fetus are unknown. Women of child-bearing potential must agree to remain abstinent or use highly effective contraception (defined as contraceptive measures that result in a failure rate of \\\u003C1% per year) during the treatment period and for at least 2 days after the last dose of acalabrutinib, 90 days after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer. Men with female sexual partners of childbearing potential should agree to remain abstinent or use contraceptive measures which include a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C1% per year during the treatment period and for at least 90 days after the last dose of venetoclax or 6 months after the last dose of obinutuzumab, whichever is longer. Men should refrain from donating sperm during the same period. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who exhibit any of the following conditions at screening will not eligible for admission into the study:\n* Participants who have progressed or relapsed after receiving either a BTK inhibitor or BCL2 inhibitor.\n* Participants who are receiving any other investigational agents, or have received investigational agents within 4 weeks (or 3 half-lives, whichever is longer) of beginning treatment.\n* Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., within 28 days of the first dose of study drug or chronic administration of \\>20 mg\u002Fday of prednisone equivalent corticosteroid within 7 days of the first dose)\n\n  \\-- Note: Glucocorticoids for lymphoma symptom palliation are allowed but must be discontinued at time of initiation of protocol therapy.\n* History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to obinutuzumab, venetoclax, or acalabrutinib. Patients with reactions to other CD20 monoclonal antibodies (e.g. rituximab, ofatumumab) are not excluded if they were able to eventually tolerate treatment in an outpatient setting without grade 2 or higher infusion reactions.\n* Participants who have a history of other malignancies except:\n\n  * Malignancy treated with curative intent and with no known active disease present and felt to be at low risk for recurrence by treating physician. Current adjuvant hormonal therapy for disease treated with curative intent is permissible.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Low-risk prostate cancer on active surveillance\n  * Other exceptions may be made after consultation with the study chair\n* Participants with known leptomeningeal or brain metastases. Imaging or spinal fluid analysis to exclude CNS involvement is not required, unless there is clinical suspicion by the treating investigator.\n* Participants who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, participants who have not adequately recovered from the side effects of any major surgery (defined as requiring general anesthesia), or participants that may require major surgery during the course of the study.\n* Vaccinated with live, attenuated vaccines within 28 days of study entry or need for live virus vaccines at any time during study period.\n* Patients with human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions between certain components of anti-retroviral therapy and venetoclax. Patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded. Those who are positive for either hepatitis B surface antigen and\u002For hepatitis B core antibody but negative for HBV DNA will be managed. Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.\n* Ongoing or recent infection requiring intravenous antimicrobials at time of screening. Patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications.\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, compromise the subject's safety, or put the study outcomes at undue risk.\n* Lactating or pregnant women are excluded from this study because venetoclax has been shown to decrease implantation, litter size, live fetuses, and fetal body weight in animal models. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. These potential risks may also apply to other agents used in this study.\n* Known bleeding disorders (e.g. von Willebrand's disease) or hemophilia.\n* Presence of a bleeding gastrointestinal ulcer diagnosed by endoscopy within 3 months prior to enrollment.\n* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n* Participants who require warfarin or other vitamin K antagonists for anticoagulation (other anticoagulants are allowed).\n* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. Patients with atrial fibrillation are allowed as long as they are adequately rate controlled.\n* Participants who require concurrent treatment with strong CYP3A inhibitors or strong CYP3A inducers are excluded from the study. If patients are receiving strong CYP3A inhibitors\u002Finducers at time of screening but do not require continuous administration of these agents, these patients are eligible if there is a 7-day washout period between discontinuation of the strong CYP3A inhibitor\u002Finducer and initiation of the first study drug, acalabrutinib.\n* Participants who require concurrent treatment with P-gp inhibitors or narrow therapeutic index P-gp substrates are excluded from the study. If patients are receiving P-gp inhibitors or narrow therapeutic index P-gp substrates at time of screening but do not require continuous administration of these agents, these patients are eligible if there is a 7-day washout period between discontinuation of the P-gp inhibitor and initiation of venetoclax.\n* Unable to swallow capsules, a large number of tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel if thought by the investigator to compromise systemic absorption, active, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.\n* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the participant at undue risk or interfere with the study.\n* History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).",{"count":141,"type":21},72,[24,25],"This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL).\n\nThe names of the study drugs involved in this study are:\n\n* Acalabrutinib\n* Venetoclax\n* Obinutuzumab",[145,35],"Mantle Cell Lymphoma",[145,35],"2026-01-19",{"date":149,"type":42},"2026-01-21",{"date":151,"type":42},"2021-07-02",{"date":153,"type":21},"2027-12-31",{"name":155,"class":79},"Austin I Kim",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":105},"100586545","phase-1-phase-1-study-of-baff-car-t-cells-lmy-920-for-treatment-of-relapsed-or-refractory-chronic-lymphocytic-leukemia--small-lymphocytic-lymphoma-100586545","NCT06916767","Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia \u002F Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Histologically confirmed chronic lymphocytic leukemia (including small lymphocytic lymphoma)\n\n   * Relapsed after 2 or more lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.\n2. No evidence of CNS lymphoma.\n3. Male or female ≥ 18 years of age.\n4. ECOG Performance status ≤ 2 \\[See Appendix 1\\].\n5. Presence of Presence of active disease for participants with CLL and SLL and presence of measurable disease for participants with SLL.\n\n   A. CLL\u002FSLL (note that SLL participants must have both measurable disease and active disease): Active disease as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), with at least one of the following criteria21:\n   * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia. Cutoff levels of Hb \\\u003C10 g\u002FdL or platelet counts \\\u003C100 × 109\u002FL are generally regarded as indication for treatment.\n   * Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n   * Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n   * Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).\n   * Disease-related symptoms as defined by any of the following:\n\n     * Unintentional weight loss ≥10% within the previous 6 months.\n     * Significant fatigue (ie, ECOG performance scale 2 or worse; cannot work or unable to perform usual activities).\n     * Fevers ≥100.5°F or 38.0°C for 2 or more weeks without evidence of infection.\n     * Night sweats for ≥1 month without evidence of infection. B. Measurable disease for participants with SLL: At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.\n6. \\>2 weeks since prior radiation therapy or 5 half-lives for systemic therapy at the time of leukapheresis, whichever is shorter (Note: Obinutuzumab pre-treatment of CLL\u002FSLL participants must start at the latest 14 days prior to apheresis).\n7. Total bilirubin ≤ 1.5 X upper institutional limit of normal (except in participants with Gilbert's syndrome, active hemolysis or disease involvement of the liver).\n8. AST (SGOT)\u002FALT ≤ 2.5 X institutional upper limit of normal.\n9. Calculated creatinine clearance ≥ 30ml\u002Fmin.\n10. Cardiac ejection fraction of ≥50%\n11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n12. Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.\n\n    A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\n    Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n    The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\nWith female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the BAFF CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the BAFF CAR- T cell infusion to avoid potential embryonal or fetal exposure.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from study enrollment:\n\n1. ASCT within 6 weeks of informed consent.\n2. History of allogeneic hematopoietic stem cell transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by lymphoma or leukemia. Participants with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.\n5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).\n6. Known active additional malignancies which require systemic treatment (non-immediately morbid malignancies receiving only low-toxicity regimens such as hormone suppression for prostate or breast cancer may be allowed at the judgment of the investigator).\n7. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n8. New York Heart Association class IV congestive heart failure.\n9. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n10. Active infection requiring intravenous systemic treatment.\n11. HIV seropositivity.\n12. Pregnant or breastfeeding women are excluded from this study because LMY-920 therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with LMY-920, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n13. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n14. Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded.)\n15. Participants with history of active and clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n16. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n17. History of autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.\n\nPre-infusion Safety Check\n\n* Participants will undergo a pre-lymphodepletion safety check in the 48h preceding lymphodepletion with Fludarabine and Cyclophosphamide. The objective of these criteria is to avoid infusion in participants with acutely heightened risk of toxicity.\n* Participants must continue to meet eligibility criteria prior to initiation of lymphodepletive chemotherapy, with exception of the absolute lymphocyte count. This eligibility re-check will be done up to 48 hours prior to initiation of lymphodepletion.\n\nThe following findings at the pre-lymphodepletion safety check will require a delay in chemotherapy administration until resolved:\n\n* Symptoms, signs or laboratory markers of active infection or systemic inflammatory response.\n* Symptoms, signs or laboratory markers of an uncontrolled medical condition, including but not limited to decompensation of cardiac or pulmonary conditions. These changes exclude symptoms, signs or laboratory markers of disease progression, as long eligibility criteria are met.\n\nIf the condition that leads to failure to meet eligibility criteria is considered irreversible by the principal investigator, participant participation in the study will be discontinued.\n\nParticipants will undergo a pre-infusion safety check on day -3 or 0. The objective of these criteria is to avoid infusion in participant with acutely heightened risk of toxicity.\n\nParticipants must meet the following organ function criteria prior to LMY-920 cell infusion:\n\n* Total bilirubin ≤ 2 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 times normal) or of non - hepatic origin.\n* AST (SGOT) and ALT (SGPT) ≤ 4 X institutional upper limit of normal\n* Serum Creatinine ≤ 2 X the institutional upper limit of normal\n* Participants must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n* Absence of clinical signs, symptoms, or laboratory markers of cardiac dysfunction.\n\nThe following findings at the pre - infusion safety check will require a delay in the infusion until resolved:\n\n* Use of corticosteroids within 2 days prior to day 0 infusion, with the exception of agents used for prevention of emesis during lymphodepletive chemotherapy.\n* Neurologic symptoms suggestive of an active central nervous system condition.\n* Signs or laboratory markers of active infection or systemic inflammatory response.\n\nParticipants presenting any of the following findings will NOT receive a LMY- 920 infusion:\n\n* Signs or laboratory markers of active infection or systemic inflammatory response.\n* Participants with fever over 38.2 degrees Celsius (detected in 2 separate measurements separated by at least 15 minutes)\n* Delay and re-conditioning (if delay is longer than 48 hours) can be considered in participants who have resolution of their symptoms.",{"count":163,"type":21},18,[24],"CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL\u002FSLL, possibly secondary to the suppressive effect of circulating B cells on T cell function.\n\nBAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.",[167,168,35],"Relapsed CLL","Refractory CLL",[170],"BAFF CAR-T cells","2025-11-07",{"date":173,"type":42},"2025-11-10",{"date":175,"type":42},"2025-07-15",{"date":153,"type":21},{"name":178,"class":79},"Paolo Caimi, MD",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":197,"locationsCount":105},"100579578","phase-2-axicabtagene-ciloleucel-injection-in-patients-with-relapsedrefractory-follicular-lymphoma-100579578","NCT06826118","Axicabtagene Ciloleucel Injection in Patients With Relapsed\u002FRefractory Follicular Lymphoma","A Single-Arm, Multicenter, Prospective, Exploratory Clinical Study of Axicabtagene Ciloleucel Injection in Patients With Relapsed\u002FRefractory Follicular Lymphoma","Inclusion Criteria:\n\n1. Histologically confirmed follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2016 classification criteria\n2. Subjects with relapsed or refractory FL after prior second-line or higher therapy Prior therapy must include: anti-CD20 monoclonal antibody in combination with an alkylating agent (anti-CD20 monoclonal antibody monotherapy is not eligible as a line of therapy for eligibility). Subjects who have had stable disease (no recurrence) for more than 1 year after completion of their last treatment do not meet the enrollment criteria Translated with DeepL.com (free version)\n3. At least one measurable lesion according to the Lugano 2014 classification (Cheson 2014). Lesions with prior radiotherapy were considered measurable only if definitive progression was confirmed after completion of radiotherapy.\n4. Patients with FL lymphoma secondary to central may be included in the\n5. Previous systemic therapy at least 2 weeks or 5 half-lives (whichever is shorter) from the start of leukapheresis, except for immune checkpoint inhibitors\u002Fagonists; Systemic immune checkpoint inhibitor\u002Fagonist therapy at least 3 half-lives from leukapheresis (e.g., Ipilimumab, Ivolumab, Pembrolizumab, Atezolizumab, OX40 agonist, 4-IBB agonist). Atezolizumab, OX40 agonist, 4-IBB agonist)\n6. Toxic reactions from prior anti-lymphoma therapy must stabilize and recover to ≤ grade 1 (except for non-clinically significant toxicities such as alopecia\u002Fbalding)\n7. ≥ 18 years old\n8. ECOG physical status score of 0 or 1\n9. Absolute neutrophil count (ANC) ≥ 1.0×10\\^9\u002FL\n10. Platelet count ≥ 75×10\\^9\u002FL\n11. Absolute lymphocyte count ≥ 0.1×10\\^ 9\u002FL\n12. Adequate renal, hepatic, pulmonary, and cardiac function, defined as: 1) total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), except in subjects with Gilbert's syndrome; 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN 3) serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCr) ≥ 60 mL\u002Fmin, with creatinine clearance estimated based on the cockcroft-Gault formula; 4) cardiac ejection fraction ≥ 50%, absence of pericardial effusion as determined by echocardiography (ECHO), and absence of clinically significant cardiac arrhythmia; 5) baseline transcutaneous oxygen saturation \\> 92% under room ventilation; 6) absence of clinically significant chest pain; and ) absence of clinically significant pleural effusion.\n13. A negative serum pregnancy test is required for women of childbearing potential (women who have been surgically sterilized or who are at least 2 years postmenopausal are not considered to be of childbearing potential).\n\nExclusion Criteria:\n\n1. Converted FL\n2. Small lymphocytic lymphoma\n3. The histologic grading of FL was 3b\n4. lymphoplasmacytic lymphoma\n5. Subject has had other malignant tumors unless he\u002Fshe has survived disease-free and has not received antitumor therapy for at least 3 years; except for non-melanoma skin tumors, carcinoma in situ (e.g., cervix, bladder, breast)\n6. Autologous Hematopoietic Stem Cell Transplantation Within 6 Weeks Prior to Scheduled Infusion of Achille's Bromide Injection\n7. Has performed allogeneic hematopoietic stem cell transplants\n8. Previous CD19-targeted therapy\n9. Previous chimeric antigen receptor cell therapy or other genetically modified T-cell therapy.\n10. History of severe rapid-onset hypersensitivity reactions to aminoglycosides\n11. Presence or suspicion of uncontrolled fungal, bacterial, viral or other infections that require intravenous drug therapy\n12. Known human immunodeficiency virus (HIV) infection or active acute or chronic hepatitis infection (HBV or HCV). Subjects with a history of hepatitis must undergo standard serologic or genetic testing in accordance with the most recent version of clinical guidelines\u002Finstitutional protocols to confirm resolution of infection prior to enrollment.\n13. Known history of lymphoma involving the entire gastric wall\n14. Presence of any indwelling tube or catheter (e.g., percutaneous nephrostomy tube, indwelling urinary catheter, indwelling biliary drain, or pleural\u002Fperitoneal\u002Fpericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted.\n15. Patients with primary central nervous system lymphoma (PCNSL)\n16. Subjects with lymphomatous infiltration of the atria or ventricles\n17. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, congestive heart failure class II or worse according to the New York Heart Association cardiac classification, or other clinically significant cardiac disease within 12 months prior to enrollment\n18. Anticipated emergencies requiring urgent treatment due to rapid tumor progression within 6 weeks of leukapheresis (e.g., tumor mass compression, tumor lysis syndrome)\n19. End-organ damage due to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years, or systemic use of immunosuppressive or other systemic disease-control medications. Subjects with a history of autoimmune hypothyroidism who are on a stable dose of thyroid replacement hormone therapy and type I diabetes mellitus on a stable insulin regimen are eligible for enrollment in this study.\n20. History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment and history of DVT at the end of the upper extremity within 3 months prior to pretreatment chemotherapy\n21. Any medical condition that may affect the assessment of safety or efficacy\n22. Has had a severe rapid-onset hypersensitivity reaction to any of the drugs to be used in this study\n23. Live, attenuated vaccines administered within ≤6 weeks prior to the start of the pretreatment regimen or whose use is expected to be required during the course of the study;\n24. Women of childbearing age who are breastfeeding\n25. Male or female subjects who are unwilling to use contraception from the date of signed informed consent until 6 months after completion of pretreatment chemotherapy, or 6 months after completion of an infusion of Aquilensa\n26. Male or female subjects who are unwilling to use contraception from the date of signed informed consent until 6 months after completion of pretreatment chemotherapy, or 6 months after completion of an infusion of Aquilensa",{"count":187,"type":21},30,[25],"A prospective collection of data on the treatment of Chinese patients with relapsed\u002Frefractory follicular lymphoma (FL) using Axicabtagene Ciloleucel Injection, and evaluation of the efficacy and safety of Axicabtagene Ciloleucel Injection in this treatment.",[118,117,35],"2025-02-10",{"date":193,"type":42},"2025-02-13",{"date":195,"type":42},"2025-02-08",{"date":46,"type":21},{"name":104,"class":79},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":105},"100442827","solving-riddles-through-sequencing-100442827","NCT05046444","Solving Riddles Through Sequencing","Testing the Diagnostic Supremacy of Sequencing-only Approaches in Hematologic Malignancies: an Observational Trial","SIRIUS","Inclusion Criteria:\n\n* Patients having been investigated with a suspected hematological disorder and:\n* Having unclear diagnosis after internal routine diagnosis\n* Unusual clinical course\n* Unusual r\u002Fr status or non-responder\n* Multiple parallel hematological conditions\n* Difficult\u002Frare therapy associated\u002Fsecondary neoplasms\n* Current diagnostic workup is not satisfactory in terms of (1) accuracy (2) clinical behavior\n* Only samples of patients min. 18 years of age will be used\n* Material with a minimum of 20% tumor content in bone marrow or peripheral blood sample\n* Patient´s informed consent\n\nExclusion Criteria:\n\n* Sample is not fit for state-of-the-art diagnosis, fails initial quality control. For quality insurance we will exclude samples with wrong anticoagulant sent. Samples with damage due to meteorological reasons (freeze-thaw damage or elevated temperature) will be excluded.\n* Samples with to scarce material jeopardizing routine gold-standard diagnosis will be excluded (tumor content \\\u003C 20 %).","99 Years",{"count":208,"type":21},100,"OBSERVATIONAL","During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and\u002For bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and\u002For WTS and if unclear cases can be efficiently resolved.",[212,213,214,215,35,216],"Leukemia","Hematologic Malignancy","Rare Diseases","Refractory Leukemia","Unknown Primary Tumors","2024-12-14",{"date":219,"type":42},"2024-12-17",{"date":221,"type":42},"2022-01-19",{"date":223,"type":21},"2026-10-01",{"name":225,"class":226},"Munich Leukemia Laboratory","INDUSTRY",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100563363","phase-1-a-study-of-hdm2005-in-patients-with-relapsedrefractory-b-cell-lymphoma-and-advanced-solid-tumor-100563363","NCT06615193","A Study of HDM2005 in Patients With Relapsed\u002FRefractory B-cell Lymphoma and Advanced Solid Tumor","A Phase Ia\u002FIb, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HDM2005 in Patients With Relapsed\u002FRefractory B-cell Lymphoma and Advanced Solid Tumor","Inclusion Criteria:\n\n1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;\n2. Male or female aged ≥ 18 years at the time of signing the ICF;\n3. B-cell lymphoma: ECOG performance status of 0-2;\n4. Advanced solid tumors: ECOG performance status of 0-1;\n5. Life expectancy of at least 3 months;\n6. Dose escalation phase: Histopathologically confirmed relapsed\u002Frefractory B-cell lymphoma following at least 2 prior lines of systemic therapy;\n7. Dose expansion phase: relapsed\u002Frefractory B-cell lymphoma and advanced or metastatic solid tumor of specified type.\n8. All subjects are required to provide archived tissue (5 unstained sections) obtained within the previous 2 years or fresh tissue for ROR1 expression testing at the central laboratory; in addition, relapsed\u002Frefractory lymphoma subjects are required to provide tissue sections used for previous pathological diagnosis for pathological consultation at the central laboratory;\n9. Relapsed\u002Frefractory B-cell lymphoma: Subjects in Phase Ia dose escalation phase should have evaluable lesions; subjects in Phase Ib dose expansion phase should have at least 1 radiographically measurable lymph node or extranodal malignant tumor lesion (intranodal lesion defined as having a long diameter \\> 1.5 cm; extranodal lesion having a long diameter \\> 1.0 cm) as assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) according to 2014 Lugano criteria, and a lesion that has previously received radiotherapy is considered measurable when it shows unequivocal progression after completion of radiotherapy;\n10. Advanced solid tumors: subjects are required to have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 ;\n11. Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy;\n12. Subjects have adequate organ and bone marrow function;\n13. Female subjects of childbearing potential should agree to use contraception methods (e.g., intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days before study enrollment; and male subjects should agree to use contraceptive avoidance measures during the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. B-cell lymphoma: known central nervous system (CNS) involvement .\n2. Advanced solid tumors: Patients with active brain metastases (defined as stable for \\\u003C 4 weeks, or symptomatic, or requiring antiepileptic drug\u002Fhormonal therapy, or meningeal metastases);\n3. Subjects with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by ≥ Grade 2 serum bilirubin, ≥ Grade 3 skin involvement, or ≥ Grade 3 diarrhea or receiving systemic immunosuppressive therapy\u002Fprophylaxis for GVHD);\n4. Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al;\n5. History of severe bleeding disorders ;\n6. History of chronic pancreatitis or acute pancreatitis within 6 months;\n7. History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease;\n8. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage, VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled);\n9. Prior solid organ transplantation;\n10. Persistent peripheral neuropathy \\> Grade 1 at baseline;\n11. Clinically significant cardiovascular or cerebrovascular diseases;\n12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic therapy (except for localized skin or nail bed fungal infection) at enrollment;\n13. Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis;\n14. Receiving corticosteroids (prednisone equivalent more than 30 mg\u002Fday);\n15. Contraindication to any component of HDM2005;\n16. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma\u002FCOPD;\n17. Female subjects who are pregnant, lactating or planning to become pregnant during the study;\n18. Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements;\n19. Prior or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, could affect the outcome of the study, prevent the subject from participating in the study entirely, or is not in the subjects' best interest.",{"count":235,"type":21},111,[24],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed\u002Frefractory B-cell lymphoma and advanced solid tumors.",[239,35,240],"Advanced Solid Tumors","Relapsed Hematologic Malignancy","2024-09-23",{"date":243,"type":42},"2024-09-26",{"date":245,"type":42},"2024-08-12",{"date":247,"type":21},"2028-02-01",{"name":249,"class":226},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",8]