[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Australasian Leukaemia and Lymphoma Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100538174","phase-2-epcoritamab-epcor-containing-combination-salvage-therapy-followed-by-asct--epcor-consolidation-in-patients-with-relapsed-lbcl-100538174",false,"NCT06287398","Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL","A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Confirmed diagnosis of DLBCL, Not-otherwise specified (NOS), Transformation of indolent B-cell lymphoma, High-grade B-cell lymphoma (HGBCL), NOS, Diffuse-large BCL (DLBCL)\u002F High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements or Follicular large B-cell lymphoma according to World Health Organization (WHO) 2016 or 2022 criteria that has relapsed or progressed after one line of chemoimmunotherapy\n3. Transplant eligible according to local assessment\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n5. Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5cm in longest axis or an extranodal site greater than 1.0cm in longest axis AND baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) scans must demonstrate positive lesion compatible with CT defined anatomical tumour sites\n6. Histological confirmation of tumour CD20 positivity, analysed by immunohistochemistry, on a pre-enrolment tissue sample performed after most recent prior therapy\n7. Adequate renal function\n\n   \\- Creatinine clearance greater than 45mL per min (Cockcroft Gault formula)\n8. Adequate hepatic function:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3x Upper Limit of Normal (ULN)\n   * Bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) or less than or equal to 3 if documented liver involvement and\u002For Gilbert's disease.\n9. Adequate haematologic function:\n\n   * Haemoglobin greater than or equal to 90g\u002FL (transfusion support permitted)\n   * Absolute neutrophil count greater than or equal to 1.0 x 109 per L; growth factor support allowed in case of bone marrow involvement\n   * Platelet count greater than 75 x 109 per L or greater than or equal to 50 x 109 per L if documented marrow involvement\n10. Able to take oral medications\n11. Adequate washout of prior therapies:\n\n    * At least 4 weeks since last dose of immunochemotherapy, radio-conjugated or toxin-conjugated compound, or other investigational anti-cancer therapy\n    * At least 6 weeks since chimeric antigen-receptor T-cell therapy\n12. Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n13. If receiving glucocorticoid treatment at screening, treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of Epcoritamab\n14. Before the first dose of Epcoritamab, during the trial and for 12 months after last administration of Epcoritamab, a woman must be either:\n\n    1. Not of childbearing potential, defined as: premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n    2. Of childbearing potential and practicing a highly effective method of birth control (as defined by the European Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials: e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that patient); true abstinence (when this is in line with the preferred and usual lifestyle of the patient) \\* If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 16b\n15. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of Epcoritamab\n16. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of Epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of Epcoritamab\n17. The patient understands the purpose of the trial and procedures required for the trial and is capable of giving signed informed consent which includes compliance with the requirements (no medical or psychiatric reason precluding participation) and restrictions listed in the informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n1. Diagnosis of primary Central Nervous System (CNS) lymphoma\n2. Active secondary CNS involvement of lymphoma at time of screening\n\n   \\- A prior history of secondary CNS lymphoma is allowed provided that it has been successfully treated and there are no features of recurrence.\n3. Prior autologous stem cell transplant\n4. Known past or current malignancy other than inclusion diagnosis, except for:\n\n   1. Cervical carcinoma of Stage 1B or less.\n   2. Non-invasive basal cell or squamous cell skin carcinoma.\n   3. Non-invasive, superficial bladder cancer.\n   4. Prostate cancer with a current Prostate Specific Agent (PSA) level less than 0.1 ng per mL e. indolent lymphoma\n   5. Indolent lymphoma\n   6. Other malignancy that has been treated with curative intent and has remained in remission for 2 years\n5. Any prior therapy with a bispecific antibody targeting CD3 and CD20\n6. Uncontrolled systemic infection\n7. Known HIV infection\n8. Known active hepatitis B or C infection based on criteria below:\n\n   * Hepatitis B virus (HBV): Patients with positive HbsAg are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HbsAg require negative hepatitis B polymerase chain reaction (PCR) before enrolment and must be treated with antiviral therapy. Patients who are hepatitis B PCR positive will be excluded.\n   * Hepatitis C virus (HCV): If positive hepatitis C antibody, patient will need to have a negative hepatitis C ribonucleic acid (RNA) before enrolment. Patients who are hepatitis C RNA positive will be excluded.\n9. Seizure disorder, unless seizure-free for 12 months on established anticonvulsant therapy without the requirement for modification to anticonvulsants within the prior 12 months\n10. Known clinically significant cardiac disease, including:\n\n    1. Onset of unstable angina pectoris within 6 months of signing the patient informed consent form (PICF)\n    2. Acute myocardial infarction within 6 months of signing the PICF\n    3. Congestive heart failure (grade III or IV as classified by the New York Heart Association\n    4. Decreased ejection fraction of less than 45%\n11. Confirmed history or current autoimmune disease requiring permanent immunosuppressive therapy. Low-dose prednisolone (less than or equal to 10mg\u002Fday or equivalent) for rheumatoid arthritis or similar conditions is allowed.\n12. Exposed to live or live attenuated vaccine within 4 weeks prior to signing PICF\n13. Women who are pregnant or lactating.\n14. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n15. Known hypersensitivity or adverse reaction to rituximab, tocilizumab or any elements of DHAOx\n16. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:\n\n* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R\u002FR) large B-cell lymphoma who achieve a complete remission prior to planned transplant?\n* Is consolidation epcoritamab after ASCT deliverable and safe?\n* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?\n* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.\n\nParticipants will undergo three phases in this trial:\n\n1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab\n2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.\n3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.",[26,27,28,29,30,31,32],"DLBCL - Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","DLBCL, Nos Genetic Subtypes","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Large Cell Lymphoma, Relapsed","Follicular Large Cell Lymphoma","RECRUITING","2024-07-19",{"date":36,"type":37},"2024-07-22","ACTUAL",{"date":39,"type":37},"2023-12-11",{"date":41,"type":20},"2031-11",{"name":43,"class":44},"Australasian Leukaemia and Lymphoma Group","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100503323","phase-2-a-phase-2-trial-of-glofitamab-and-pirtobrutinib-in-mantle-cell-lymphoma-patients-with-prior-btk-inhibitor-exposure-100503323","NCT05833763","A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.","An Open-label, Single-arm, Phase 2 Trial of GlOfitamab anD pIrtobrutinib (LOXo-305) in Patients With Mantle Cell Lymphoma and Prior Exposure to a BTK Inhibitor","GOlDiLOX","Inclusion Criteria:\n\n1. Ages 18 years old or above\n2. A confirmed diagnosis of MCL according to World Health Organization (2016) criteria\n3. At least one site of measurable disease not previously irradiated (defined as at least one bi-dimensionally measurable nodal lesion of greater than or equal to 1.5cm in longest dimension)\n4. Life expectancy (in the opinion of the investigator) of greater than or equal to 18 weeks\n5. Prior therapy with a BTK inhibitor alone or in combination and:\n\n   1. Progression or relapse post BTK inhibitor or\n   2. Failed to achieve PR following 12 weeks of BTK inhibitor therapy\n6. Prior TRAEs must have recovered to Grade 1 or less with the exception of alopecia, peripheral neuropathy and lymphopenia.\n7. ECOG 0-2\n8. Adequate washout of prior therapies:\n\n   1. Broad field radiation (greater than or equal to 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study treatment\n   2. Palliative limited field radiation must be completed 7 days prior to study treatment.\n   3. Targeted agents, investigational agents, therapeutic monoclonal antibodies\u002Fantibody drug conjugates or cytotoxic chemotherapy must be completed 5 half-lives or 2 weeks (whichever is shorter) prior to study treatment (except for BTK inhibitors which may be continued until 1 day prior to planned first therapy with pirtobrutinib)\n   4. Steroids (prednisolone less than or equal to 100mg daily or equivalent for up to 14 days are permitted during screening for control of lymphoma related symptoms\n9. Ability to take oral medications\n10. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.\n11. Willingness of men and women of reproductive potential to observe conventional and highly effective and acceptable birth control methods for the duration of treatment and for six months following the last dose of study treatment\n12. Women of childbearing potential must have a negative serum pregnancy test within seven days of enrolment\n13. Adequate coagulation, defined as aPTT and PT not greater than 1.5xULN, unless laboratory abnormality is explained by concomitant anticoagulant medication, a lupus anticoagulant, or a factor deficiency not associated with an increased bleeding risk, as determined by the investigator.\n14. Adequate liver function:\n\n    * ALT and AST less than or equal to 3X ULN, or less than or equal to 5X ULN if documented liver involvement\n    * Total bilirubin less than or equal to 1.5X ULN or less than or equal to 5X ULN if documented liver involvement and\u002For Gilbert's Disease\n15. Adequate renal function\n\n    \\- Creatinine clearance greater than or equal to 30mls\u002Fminute according to Cockroft-Gault formula\n16. Adequate haematological parameters\n\n    * Haemoglobin greater than or equal to 80g\u002FL (transfusion support permitted)\n    * Absolute neutrophil count greater than or equal to 1.0x10\\^9\u002FL (May be G-CSF supported)\n    * Platelets greater than or equal to 75 X 10\\^9\u002FL. OR platelets greater than or equal to 50 X 10\\^9\u002FL if documented marrow involvement or splenomegaly (must be platelet transfusion independent for 7 days prior to first dose of obinutuzumab\n17. Sufficient archival tissue is available for central review or after discussion with the CPI\n\nExclusion Criteria:\n\n1. Inability to comply with protocol mandated hospitalisations\n2. For patients enrolling on the safety cohort, a history of allogeneic transplantation within 12 months of enrolment or ongoing chronic GVHD or immunosuppressive therapy.\n3. Autologous SCT or CAR-T therapy within 6 weeks of enrolment\n4. Active central nervous system involvement with MCL\n5. Prior treatment with pirtobrutinib or demonstrated refractoriness to a CD20xCD3 bispecific antibody.\n6. Have a known severe hypersensitivity to any of the excipients of pirtobrutinib, glofitamab, tocilizumab or obinutuzumab.\n7. History of stroke or intracranial haemorrhage within six months of enrolment.\n8. Live vaccination within 28 days of enrolment.\n9. Major surgery or significant traumatic injury within 28 days of study treatment or the anticipation of major surgery during study treatment (surgical procedures for the diagnosis of lymphoma such as lymph node resection\u002F laparoscopy are allowed provided patient is considered fit for treatment as judged by investigator)\n10. Significant cardiovascular disease defined as:\n\n    1. Unstable angina or acute coronary syndrome within 2 months of registration\n    2. History of myocardial infarction within 3 months prior to registration\n    3. Documented LVEF by any method of = 40% during screening\n    4. Grade 3 or higher NYHA functional classification system of heart failure\n    5. Uncontrolled or symptomatic arrhythmias\n11. Prolongation of the QT interval corrected for heart rate (QTcF) greater than 470 msec on at least 2\u002F3 consecutive electrocardiograms (ECGs), and mean QTcF greater than 470 msec on all 3 ECGs, during Screening. QTcF is calculated using Fridericia's Formula (QTcF): QTcF euqal to QT\u002F(RR0.33) Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switching to another drug not known to be associated with QTcF prolongation. Correction for underlying bundle branch block (BBB) allowed. Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias\n12. Known human immunodeficiency virus (HIV) infection\n13. Known active HBV or HCV infection based on criteria below:\n\n    1. HBV: Patients with positive HbsAg are excluded. Patients with positive hepatitis B core antibody antiHBc and negative HbsAg require negative hepatitis B PCR before enrolment and must be treated with antiviral therapy. Patients who are hepatitis B PCR positive will be excluded.\n    2. HCV: If positive hepatitis C antibody, patient will need to have a negative hepatitis C RNA before enrolment. Patients who are hepatitis C RNA positive will be excluded.\n14. Known active CMV infection. Unknown or negative status are eligible.\n15. Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment.\n16. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of pirtobrutinib.\n17. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection, or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation.\n18. Active uncontrolled auto-immune cytopenia (e.g., AIHA, ITP) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrolment to maintain adequate blood counts, unless auto-immune cytopenias are secondary to MCL\n19. Active second malignancy unless in remission and with life expectancy greater than 2 years.\n20. Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and\u002For strong P-gp inhibitors.\n21. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.",{"count":55,"type":20},42,[23],"The goal of this clinical trial is to evaluate the safety and response of combining Pirtobrutinib and Glofitimab in patients with relapsed MCL. The main question it aims to answer are:\n\n* Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib?\n* Will this combination be safe and lead to high complete- and remission rates with no residual disease?\n\nPirtobrutinib will be given to all participants as an oral tablet for the duration of the entire study. Participants will receive other treatment in 3 phases:\n\n1. Treatment Ramp-Up\n\n   1. Treatment with Obinutuzumab by Intravenous (IV)\n   2. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive adverse events are observed, a lower initial dose will be used.\n2. Fixed course combination phase: Treatment with Glofitamab by IV\n3. Maintenance phase: Glofitamab is discontinued. 200mg oral daily",[59,60],"Mantle Cell Lymphoma","Mantle Cell Lymphoma Refractory","2024-01-04",{"date":63,"type":37},"2024-01-08",{"date":65,"type":37},"2023-10-12",{"date":67,"type":20},"2037-04",{"name":43,"class":44},""]