[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,63,76,99,135,158,181,204,233,260,280,308,333,368],{"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":43,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[28,35,44,45,46,47,48,49,42],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":21},"2026-07-16",{"date":58,"type":21},"2032-12-31",{"name":60,"class":61},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":64,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":26,"conditions":67,"keywords":68,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":62},"100624942",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],[28,35,44,45,46,47,48,49,42],"2026-07-01",{"date":71,"type":54},"2026-07-02",{"date":73,"type":21},"2026-07-07",{"date":58,"type":21},{"name":60,"class":61},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":62},"100401698","phase-2-study-of-pembrolizumab-with-bendamustine-in-hodgkin-lymphoma-100401698","NCT04510636","Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma","Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed\u002FRefractory Hodgkin Lymphoma","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial and adhere to trial procedures.\n* Be age ≥18 years at the time of signing informed consent.\n* Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve CR or PR to most recent therapy) classical Hodgkin Lymphoma (RR HL).\n* Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline, i.e. ABVD or BEACOPP.\n* Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT (as per institutional criteria).\n* May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.\n* May have received a prior autologous stem cell transplant but must be at least ≥100 days post-auto-transplant, and all transplant- related adverse events must have resolved to a grade 1 or less, and patients are not on immunosuppression, and meet all other eligibility criteria.\n* Must have measurable or evaluable disease, as defined as at least one lesion that can be accurately measured in at least 2 dimensions by CT\u002FPET scan. The minimum measurement must be \\>15 mm in the longest dimension or \\>10 mm in the short axis. Baseline FDG-PET scan must be positive (i.e. FDG-avid HL). Measurements must be done within 28 days prior to trial inclusion..\n* Must have Eastern Cooperative Group (ECOG) performance status 0-1.\n* Must have an estimated life expectancy of greater than 90 days.\n* Demonstrate adequate organ and bone marrow function. All screening laboratory tests should be performed within 7 days of treatment initiation.\n* If FOCBP (defined as any female who has experienced menarche and who has not undergone surgical sterilization (i.e. hysterectomy or bilateral oophorectomy) and is not postmenopausal (menopause is defined as 12 months of amenorrhea in a woman over the age of 45 years in the absence of other biological or physiological causes), eligible patients must have a negative pregnancy test within 72 hours prior to the first dose of study treatment. If the urine test is positive, a serum pregnancy test will be required.\n* All participants must be willing to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug.\n* If male, and sexually active with FOCBP, must agree to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug.\n* Azoospermic male, or male and FOCBP who are continuously not heterosexually active, are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described.\n* Must be available for treatment, assessment and follow-up.\n\nExclusion Criteria:\n\n* There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine.\n* Patient receiving any other investigational agents, or on current treatment for RR HL, or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n\nNote: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.\n\n* Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, small molecule, or biologic agent within 4 weeks of the first dose of treatment, or who has not recovered (i.e., ≤Grade 1 or to baseline) from AEs due to a previously administered agent.\n* Patient has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study, or who has not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patient has received pembrolizumab, or another anti-PD1, or anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or anti-OX-40 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with disease progression whilst on therapy, or within 3 months of completion of this line of therapy, without intervening systemic therapy (including chemotherapy, antibody drug conjugates or other targeted agents).\n* Patient has received prior treatment with bendamustine, either as monotherapy or as part of a combination regimen.\n* Patient has undergone prior allogeneic hematopoietic stem cell transplant.\n* Patient has another concurrent active malignancy (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that has undergone potentially curative therapy), and must be disease-free and off treatment for \\> 3 years.\n* Patient has known active central nervous system or meningeal disease.\n* Patients with active or past documented autoimmune disease that has required treatment in the past 2 years.\n* Patient is receiving systemic steroid therapy at a dose of \\> 10 mg\u002Fday of prednisone (or equivalent) for 7 days prior to day 1 of study treatment.\n* Has an uncontrolled co-existing illness, including but not limited to: ongoing or active infection requiring systemic therapy; systemic congestive heart failure Class III or IV by NYHA criteria; unstable angina pectoris or cardiac arrhythmia; in patients status post allogeneic transplantation uncontrolled GVHD.\n* Patient has a history of (non-infectious) pneumonitis that has required steroid treatment, or concurrent active pneumonitis.\n* Patient is pregnant, or nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab and\u002For bendamustine.\n* Has a known history of Human Immunodeficiency Virus (HIV), active tuberculosis (TB, Mycobacterium tuberculosis), or active hepatitis B or hepatitis C.\n* Patient has received a live vaccine within 30 days prior to first dose of study drugs.\n* Patient is eligible for autologous or allogeneic stem cell transplant, unless patient has declined this, therefore rendering themselves ineligible for stem cell transplantation.",{"count":20,"type":21},[25],"This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.",[87,30,88],"Classical Hodgkin Lymphoma","Refractory Cancer","2026-06-19",{"date":91,"type":54},"2026-06-23",{"date":93,"type":54},"2021-12-20",{"date":95,"type":21},"2026-11-01",{"name":97,"class":98},"University Health Network, Toronto","OTHER",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100564854","phase-1-a-study-to-investigate-safety-and-effectiveness-of-bgb-16673-in-combination-with-other-agents-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100564854","NCT06634589","A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1b\u002F2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","Key Inclusion Criteria:\n\n* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF\n* Confirmed diagnosis of a R\u002FR B-cell malignancy\n* Protocol-defined measurable disease\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab\n* Substudies 1, 3, and 4 Inclusion Criterion:\n\n  * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL\u002Fmin\n* Substudy 2 Inclusion Criteria:\n\n  * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression\n  * Adequate renal function as indicated by eGFR of ≥ 30 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Treatment-naive B-cell malignancies\n* Unable to comply with the requirements of the protocol\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively\n* Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening\n* Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period\n* Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab\n* Substudy 1 Exclusion Criterion:\n\n  * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)\n* Substudy 2 Exclusion Criterion:\n\n  * Participants who discontinued prior zanubrutinib treatment due to intolerance\n* Substudies 3 and 4 Exclusion Criteria:\n\n  * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment\n  * All participants with a prior allogeneic stem cell transplant\n  * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":107,"type":21},80,[24,25],"The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R\u002FR) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.",[111,30,88,112],"B-cell Malignancy","B-cell Lymphoma",[114,115,116,117,118,119,120,121,122,123],"R\u002FR B-Cell Malignancies","relapsed or refractory B-Cell Malignancies","B-Cell malignancy","BGB-16673","sonrotoclax","zanubrutinib","B-cell lymphoma","Bruton Tyrosine Kinase (BTK)","Mosunetuzumab","Glofitamab","2026-06-01",{"date":126,"type":54},"2026-06-03",{"date":128,"type":54},"2024-11-27",{"date":130,"type":21},"2029-12-02",{"name":132,"class":133},"BeOne Medicines","INDUSTRY",50,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100504775","phase-2-safety-and-efficacy-of-epcoritamab-with-gemcitabine-dexamethasone-and-cisplatin-gdp-salvage-chemotherapy-in-relapsed-refractory-large-b-cell-lymphoma-100504775","NCT05852717","Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","A Phase II Trial Evaluating Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-2 within 28 days prior to registration.\n4. Histologically confirmed CD20+ relapsed large cell lymphoma according to the 5th edition of the WHO classification of the hematolymphoid tumors and the 2022 international consensus classification of mature lymphoid neoplasms. This includes de-novo and transformed from prior indolent B-cell NHL such as follicular lymphoma, or marginal zone lymphoma (33, 34). Subjects with high-grade B-cell lymphoma (HGBCL), NOS subtype, and high-grade B-cell lymphoma with c-MYC, Bcl2 and\u002For Bcl6 rearrangements (double or triple hit lymphoma) are eligible. Patients with primary mediastinal B-cell lymphoma, and T-cell histiocyte-rich B-cell lymphoma, primary cutaneous diffuse large B-cell lymphoma, leg type, Intravascular large B-cell lymphoma, Epstein-Barr virus-positive diffuse large B-cell lymphoma, NOS, Diffuse large B-cell lymphoma associated with chronic inflammation, and ALK-positive large B-cell lymphoma are eligible. Patients with Burkitt lymphoma or lymphoplasmacytic lymphoma are not eligible.\n5. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014).\n6. Have received at least 1 prior line of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy.\n7. Patients must be deemed eligible to proceed with stem cell transplantation (autologous or allogeneic) or CAR T-cell therapy per treating physician discretion. Prior autologous stem cell transplantation or CAR T-cell therapy is permitted if \\> 90 days have elapsed and the patient is deemed eligible for allogeneic stem cell transplantation or CAR T-cell therapy by the investigator. Prior allogeneic stem cell transplant recipients may be eligible if they do not have active or chronic GVHD and are not receiving immunosuppression for the prophylaxis or treatment of GVHD.\n8. Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET\u002FCT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET\u002FCT per the Lugano criteria.\n9. Archival tissue obtained within 2 years of signing consent is required if available and will be identified at screening and shipped prior to Cycle 2 Day 1. If archival tissue is not available, but the subject is undergoing a standard of care biopsy, fresh tissue from that standard of care biopsy may be used for eligibility. If a subject does not have archival tissue obtained within 2 years of signing consent or is not undergoing a standard of care biopsy, they are not eligible for the trial. Cytological or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases that has been decalcified is not acceptable.\n10. Demonstrate adequate organ function. All screening labs to be obtained within 21 days prior to registration. \\*Patients with bone marrow involvement will be eligible to participate in the study but must meet hematologic parameters.\n11. Life expectancy of ≥ 6 months, as determined by the enrolling physician or protocol designee.\n12. Females subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study treatment. If a urine test is done and it is positice ir cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Female subjects of childbearing potential and male subjects must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception.\n14. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab, or odronextamab.\n2. Known active central nervous system or meningeal involvement by large cell lymphoma at time of screening. Patients diagnosed with CNS disease who achieved and maintained CNS CR at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings).\n3. Contraindication to any drug contained in the combination therapy regimen (GDP).\n4. Known hypersensitivity or allergic reaction to epcoritamab or its' excipients.\n5. Use of any standard or experimental anti-large cell lymphoma therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \\\u003C 14 days prior to C1D1. NOTE: Prednisone up to 50 mg or equivalent for 5 days is permitted; palliative radiation is permitted only if on non-target lesions).\n6. Major surgery \\\u003C 14 days of Cycle 1 Day 1.\n7. Neuropathy Grade ≥ 2 (CTCAE v.5.0).\n8. Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumours curatively treated with no evidence of disease for at least 3 years.\n9. Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic treatment within 7 days prior to the first dose of study treatment. Prophylactic antibacterial, antiviral, and antifungal agents are allowed.\n10. Active HIV infection. NOTE: Testing for HIV antibody is required at the time of screening. Those with positive HIV antibody will require HIV viral load by PCR testing. Patients with detectable viral load will not be eligible for the study. Those with positive antibody but undetectable viral load and CD4 \\>200 will be eligible.\n11. Testing for hepatitis B (HBV) and hepatitis C virus (HCV) is required at screening. Hepatitis B testing will consist of Hepatitis B surface Antigen (HBsAg), Hepatitis B Core Antibody (HBcAb) and Hepatitis Surface Antibody (HBsAb). Hepatitis C testing will consist of Hepatitis C Antibody (HCAb). Subjects with a history of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.\n12. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, or being compliant with the study procedures.",{"count":143,"type":21},32,[25],"Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. Each cycle will last 21 days. GDP consists of gemcitabine 1000 mg\u002Fm2 IV on Days 1 and 8, cisplatin 75 mg\u002Fm2 IV on Day 1, and dexamethasone 40 mg orally on Days 1 through 4. Epcoritamab will be administered subcutaneously (SC) on Days 1, 8, and 15. Patients will receive granulocyte colony stimulating factor (G-CSF) between Day 8 through Day 10 of each cycle of combination therapy.\n\nPatients will then undergo radiology imaging for disease assessment. Patients may proceed to SCT(autologous or allogeneic) or CAR T-cell therapy or epcoritamab monotherapy upon completion of Cycle 3 per investigator discretion. The rationale for subjects not proceeding to autoSCT or CAR T-cell therapy will be captured in the eCRFs.\n\nPatients who do not undergo SCT or CAR T-cell therapy may have the option to receive study treatment with epcoritamab monotherapy following completion of Cycle 3. Epcoritamab monotherapy will be offered to selected subjects who become ineligible to undergo SCT or CAR T-cell therapy (such as social situation, change in subject decision). The decision to offer epcoritamab monotherapy will be per investigator's discretion. However, subjects must have demonstrated a response to the combination therapy (partial remission or complete remission) per disease assessment scans prior to offering epcoritamab monotherapy. Epcoritamab monotherapy should begin 2 weeks following Cycle 3 Day 15. Monotherapy will consist of epcoritamab 48 mg administered subcutaneously on Days 1 and 15 of each 28 day cycle for Cycle 4 to Cycle 9 or until unacceptable toxicity, or disease progression per the Lugano Criteria.",[147,30,88],"Large Cell Lymphoma, Diffuse","2026-05-01",{"date":150,"type":54},"2026-05-06",{"date":152,"type":54},"2023-10-31",{"date":154,"type":21},"2028-11-24",{"name":156,"class":98},"Dipenkumar Modi",4,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":62},"100491597","phase-2-zanubrutinib-with-pemetrexed-to-treat-relapsedrefractory-primary-and-secondary-central-nervous-system-cns-lymphomas-100491597","NCT05681195","Zanubrutinib With Pemetrexed to Treat Relapsed\u002FRefractory Primary and Secondary Central Nervous System (CNS) Lymphomas","Zanubrutinib With Pemetrexed for the Treatment of Relapsed\u002FRefractory Primary and Secondary CNS Lymphomas: A Phase II Trial With a Safety Lead-In","Inclusion Criteria:\n\n1. Any of the following diseases histologically confirmed:\n\n   1. Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease\n   2. Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease\n   3. Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma.\n2. Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)\n3. Progressed during first-line chemotherapy and\u002For radiotherapy -OR- insufficient clinical response to previous therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as Grade 3+ acute kidney injury (AKI) and\u002For transaminase elevation according to CTCAE v 5.0 criteria preventing repeat treatment exposure OR prior glucarpidase use due to high dose methotrexate delayed clearance and\u002For toxicity OR those who would have been glucarpidase candidates due to delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered or toxic plasma methotrexate concentrations (\\>1 micromole per liter) in patients with delayed methotrexate clearance) due to impaired renal function OR unable to receive high dose methotrexate induction on every 2 week +\u002F- 3 days schedule due to deconditioning and\u002FOR need for physical rehabilitation between the high dose methotrexate treatments\n4. No systemic lymphoma by positron emission tomography (PET) CT or CT scan of the chest, abdomen, and pelvis with contrast\n5. Adequate bone marrow and organ function demonstrated by:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   2. Platelets ≥ 75 x 10\\^9\u002FL and no platelet transfusion within the past 14 days prior to study enrollment\n   3. Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 14 days prior to study enrollment\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal\n   5. Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome\n   6. Creatinine Clearance (CrCl)\\> 45 mL\u002Fminute using Cockcroft-Gault formula\n6. Ability to understand and sign written informed consent prior to study entry unless the subject suffers from cognitive or physical impairment due to their CNS malignancy or due to a known underlying medical condition in which case consent could be signed by proxy\n7. Life expectancy of at least 2 months\n8. Females of childbearing potential must use highly effective method of contraception for the duration of the study and ≥ 30 days after the last dose of zanubrutinib. Female must also have a negative urine or serum pregnancy test ≤ 7 days before initial treatment.\n\n   * The investigator or a designated associate is requested to advise the patients how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Females using hormonal contraception should use barrier methods in addition.\n   * Male patients with a female partner of childbearing potential are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for up to one week after the last dose of zanubrutinib.\n\n   Agreement to use contraception during study participation\n   * Female patients of childbearing potential must practice highly effective methods of contraception.\n   * Male patients with female partners must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods. Acceptable contraception methods are included in the study protocol.\n   * Patients using hormonal contraceptives (e.g., birth control pills or devices) must use a barrier method of contraception (e.g., condoms) as well.\n9. For patients with Infectious disease, must have:\n\n   1. HIV positive with negative viral load and CD4 count \\> 400\n   2. Non-viremic Hepatitis C Virus (HCV)\n   3. HBcAb (Hepatitis B core positive) and HBsAg negative\n\nExclusion Criteria:\n\n1. Serious uncontrolled concurrent illness or comorbid condition\n2. Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer under observation. Patients with a remote history (3 years or more) of malignancy are eligible for the protocol in the absence of active disease\n3. Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol\n4. Unable to comprehend the study requirements or who are not likely to comply with the study protocol\n5. Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment\n6. Pregnant (confirmed by serum or urine β-HCG) or lactating\n7. Transaminases \\> 3 times above the upper limits of the institutional normal\n8. Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment with the exception of dexamethasone, or low dose prednisone with a total dose equivalent to 15 mg of prednisone a day or less for chronic conditions. Allogeneic stem cell transplant recipients as well as other organ transplant recipients are excluded. Autologous stem cell transplant recipients will qualify if relapse occurs at one year after the stem cell transplantation. Short course of dexamethasone up to 40 mg orally or intravenously daily with or without taper for CNS lymphoma symptom control is allowed.\n9. Patients should not have active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura).\n10. Non-healing wound, ulcer or bone fracture\n11. Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia\n12. Cerebrovascular accident or intracranial hemorrhage within 6 months of the study treatment; arterial or venous thrombotic or embolic event such as deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment. Patients with upper extremity catheter-related deep venous thrombosis will not be excluded.\n13. Concurrent use of warfarin or other vitamin K antagonists (need to be stopped 7 days prior to starting on trial drug)\n14. Infectious disease: HIV positive patients with positive viral load and CD4+ count \\\u003C 400 are excluded. HIV patients must have established and consistent infectious disease specialist care. HIV positive patients have to agree for every 12-week monitoring of viral load. Patients with the emergence of HIV viral load on the trial treatment will be referred to the infectious disease specialist and can continue on the trial treatment unless recommended to stop by the infectious disease specialist and PI. If the viral load reaches 100,000 copies per milliliter or above, the patient would be referred to an infectious disease specialist for and evaluation and would be taken off the trial.\n15. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable and if they are willing to undergo monitoring for HCV reactivation every 12 weeks. HCV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HCV viral load regardless of liver function tests (LFTs). Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n16. Patients with detectable hepatitis B surface antigen (HBsAg) are excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, are eligible if HBV DNA is undetectable and if they are willing to undergo monitoring for Hepatitis B Virus (HBV) reactivation every 12 weeks. HBV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HBV viral load regardless of LFTs. Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n17. Currently active, clinically significant cardiovascular disease including the following:\n\n    1. Myocardial infarction within 6 months before screening\n    2. Unstable angina within 3 months before screening\n    3. New York Heart Association class III or IV congestive heart failure\n    4. History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n18. Any uncontrolled active systemic infection or infection requiring systemic treatment that was completed ≤ 7 days before the first dose of therapy\n19. Participants who received a strong cytochrome P450 (CYP) 3A inhibitor or inducer within 7 days prior to the first dose of protocol anti-fungal prophylaxis, or participants who require continuous treatment with a strong CYP3A inhibitor\u002Finducer (i.e., except for any medication to be specifically mentioned in this protocol)\n20. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety, or put the study at undue risk. Participants with suspicious radiologic evidence of aspergillosis infection (i.e., chest CT and\u002For brain MRI) will not be eligible unless confirmatory laboratory testing of Beta-D glucan and aspergillus antigen are negative\n21. Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma\n22. Vaccination with a live or attenuates vaccine within 28 days prior to the first dose of zanubrutinib. Live or attenuated vaccines are not allowed during treatment with zanubrutinib\n23. Hypersensitivity to zanubrutinib or pemetrexed or any of the other ingredients of the applicable study drug",{"count":166,"type":21},15,[25],"This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.",[170,171,30,88],"Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","2026-03-02",{"date":174,"type":54},"2026-03-03",{"date":176,"type":54},"2024-04-25",{"date":178,"type":21},"2033-02",{"name":180,"class":98},"Baptist Health South Florida",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":157},"100394860","phase-1-pembrolizumab-ibrutinib-and-rituximab-in-pcnsl-100394860","NCT04421560","Pembrolizumab, Ibrutinib and Rituximab in PCNSL","A Phase Ib\u002FII Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory\u002FRelapsed Primary Central Nervous System Lymphoma (PCNSL)","Inclusion Criteria:\n\n* Participant must be able to understand and willing to sign a written informed consent document.\n* Participant must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n* Participant must be at least 18 years old on day of signing informed consent.\n* Subjects with pathologically confirmed PCNSL who progressed after CNS-directed therapy, primary refractory disease and relapsed disease are allowed. Participants should have evidence of R\u002FR disease on MRI or CSF cytology. Ocular only recurrences are allowed.\n* Subjects must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Life expectancy of \\>3 months (in the opinion of the investigator)\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1\n* Must be able to tolerate lumbar puncture and\u002For Ommaya taps\n* Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation.\n\n  * Hematology\n\n    * White Blood Count (WBC) ≥ 2 K\u002FμL\n    * Platelet count ≥ 100 K\u002FμL\n    * Absolute Neutrophil Count ≥ 1.5 K\u002FμL\n    * Hemoglobin \\> 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n  * Biochemistry\n\n    * Serum creatinine ≤1.5 x institutional ULN OR Measured or calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN (Creatinine clearance should be calculated per institutional standard)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN(≤5 × ULN for participants with liver metastases)\n    * Total bilirubin (TBILI) ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of \\\u003C 3.0 x institutional ULN) OR Direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN)\n  * Coagulation studies\n\n    * INR OR PT and Activated aPTT ≤1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test within 72 hours prior to registration.\n* Women in the following categories are not considered WOCBP:\n\n  * Premenarchal\n  * Premenopausal female with 1 of the following:\n\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n    * Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.\n  * Postmenopausal female: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n    * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n  * Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study discontinuation.\n\n  * 1\\. Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of \\\u003C 1% per year when used consistently and correctly.)\n\n    * a. Combined (estrogen- and progestogen- containing) hormonal contraception b, c\n\n      * i. Oral\n      * ii. Intravaginal\n      * iii. Transdermal\n      * iv. Injectable\n    * b. Progestogen-only hormonal contraception b, c\n\n      * i. Oral\n      * ii. Injectable\n  * 2\\. Highly Effective Methods That Have Low User Dependency (Failure rate of \\\u003C1% per year when used consistently and correctly)\n\n    * a. Progestogen- only contraceptive implant b, c\n    * b. Intrauterine hormone-releasing system (IUS) b\n    * c. Intrauterine device (IUD)\n    * d. Bilateral tubal occlusion\n    * e. Vasectomized partner: A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n    * f. Sexual abstinence: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n  * NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.\n\n    * Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).\n    * If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study discontinuation after the last dose of study treatment.\n    * If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.\n* Male participants must agree to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy:\n\n  * 1\\. Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n  * 2\\. Use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year as described in Eligibility criterion 3.1.13 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.\n  * a. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not be eligible for admission into the study.\n\n* Patients who cannot undergo MRI brain\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40,CD137)\n* Previously progressed on ibrutinib or other BTK inhibitor use (patient who have previously received BTK inhibitor but not progressed while on it are allowed)\n* Patients with \\> Grade 2 intracranial hemorrhage\n* Concomitant warfarin, any other warfarin-derivative anticoagulant, vitamin K antagonists, within 7 days before starting treatment. Note: novel oral anticoagulants (NOACs, e.g., Apixaban, Dabigatran, Edoxaban, Rivaroxaban), low molecular weight heparin (LMWH) are allowed\n* Arterial thromboembolic events such as cerebrovascular accident within 3 months before the start of study treatment\n* Active autoimmune disease requiring immunosuppressive agents or steroids (prednisone \\>10mg or equivalent)\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Requires treatment for PCNSL with high dose systemic corticosteroids defined as dexamethasone \\> 4 mg\u002Fday or bioequivalent for \\>3 consecutive days within 2 weeks of registration\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to dosing. OR 5 half-lives, whichever is shorter --- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with≤Grade 2 neuropathy may be eligible.\n* Patients who underwent major surgery ≤ 2 weeks before starting study treatment are excluded. If participant underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. Patients who plan to undergo surgery within 2 weeks of first dose of study treatment are excluded.\n* Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. Has received prior radiotherapy to CNS disease within 2 weeks of start of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella,varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has severe hypersensitivity (≥ Grade 3) to study agents and\u002For any of its excipients.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Patient is known to have an uncontrolled active systemic infection (\\>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug.\n* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association \\> Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Uncontrolled hypertension despite optimal medical management (per investigator's assessment).\n* Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin \\>8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of \\>8%.\n* Non-healing wound, ulcer or bone fracture.\n* Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Concurrent administration of medications or foods that are moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A4\u002F5 (need to be discontinued 2 weeks before starting study treatment)\n* Enzyme-inducing antiepileptic drugs (EIAED) need to be discontinued and switched to a non-EIAED 2 weeks prior to starting on trial drugs\n* Has known history of HIV\u002FAIDS\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)\n* Patients who have undergone prior allogeneic stem cell transplant\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment",{"count":189,"type":21},37,[24,25],"This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL).\n\nThe three drugs being used in the study are:\n\n* Pembrolizumab (MK3475)\n* Ibrutinib\n* Rituximab (or biosimilar)",[170,193,88,30],"Recurrent Cancer",[170,193,88,30],"2026-02-18",{"date":197,"type":54},"2026-02-20",{"date":199,"type":54},"2020-08-01",{"date":201,"type":21},"2027-01-05",{"name":203,"class":98},"Dana-Farber Cancer Institute",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":62},"100565592","phase-1-roginolisib-ioa-244-with-venetoclax-and-rituximab-for-refractoryrelapsed-chronic-lymphocytic-leukemia-cll-100565592","NCT06644183","Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory\u002FRelapsed Chronic Lymphocytic Leukemia (CLL)","A Phase 1\u002F2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory\u002FRelapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab","Inclusion Criteria:\n\n* Patients with relapsed\u002Frefractory CLL who meet iwCLL criteria for requiring treatment.\n* Patients with measurable disease as defined by at least one of: circulating lymphocytosis \\> 5000 B cells\u002Fmicroliter, bone marrow involvement \\> 30%, palpable splenomegaly or lymph nodes \\> 1.5 cm. Computer tomography (CT) at screening must be performed and followed every 2 cycles (1 cycle = 28 days).\n* Patients must have received at least two prior therapies for CLL including systemic therapy containing a covalent BTK inhibitor.\n* Patients willing to undergo a pre-treatment and on treatment bone marrow biopsy.\n* Age ≥18 years, at the time of signing the IRB approved informed consent. Because no dosing or adverse event data are currently available on the use of venetoclax in combination with roginolisib in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Platelet count ≥50 x 109\u002FL\\^\\^\\^\n  * Total bilirubin ≤ 1.5 ×institutional upper limit of normal (ULN)\\*\n  * AST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN\n  * Creatinine clearance ≥ 60 mL\u002Fmin\\*\\*\n  * \\^\\^\\^Thrombocytopenia due to marrow involvement of CLL: \\> 30 x 109\u002FL for the safety run-in, and 20 x 109\u002FL for the randomized portion of the study\n  * \\*unless increase attributed to leukemic organ involvement, hemolysis or Gilbert's syndrome. Patients who are \\\u003C 75 years may have bilirubin of ≤ 3.0 × ULN\n  * \\*\\* calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Patients with clinically inactive CNS disease or treated CNS disease that is no longer symptomatic, or who need corticosteroids or anticonvulsants may be enrolled in the study. For patients who have symptoms present, imaging and lumbar puncture must be performed to exclude a CNS condition that may impact the study conduct.\n* Willingness to undergo a pre-treatment and on-treatment bone marrow to evaluate MRD.\n* Willingness to use adequate contraception prior to study entry and for the duration of study participation.\n\n  * The effects of roginolisib on the developing human fetus are unknown.\n  * Venetoclax may cause embryo fetal harm when administered to pregnant women. Anti-CD20 targeting agents are likely to cause fetal B-cell depletion. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential will be required to have a negative serum pregnancy test during screening and a negative serum pregnancy test on Cycle 1 Day 1. 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  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of roginolisib or venetoclax administration. Contraception must be conducted up to 12 months after taking the last rituximab dose.\n* Ability to understand and the willingness to sign a written informed consent document, which includes compliance with the requirements of this protocol.\n* Eligible to receive infection prophylaxis and supportive care as per institutional guidelines.\n\nExclusion Criteria:\n\n* Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months. Patients must not have had any CLL-directed anticancer therapy within 5 half- lives of the therapy prior to Cycle 1 Day 1.\n* Patients who have received a live vaccine within 30 days of planned start of study therapy. With regards to other type of vaccines, including SARS-Co2 vaccines, these are allowed.\n* Patients requiring ongoing treatment with chronic high dose immunosuppressants (e.g., cyclosporine) or systemic steroids \\> 20 mg prednisone (or equivalent) QD. For example, patients with uncontrolled autoimmune haemolytic anaemia (AIHA) or idiopathic thrombocytopenia purpura (ITP), which requires \\> 20 mg once daily (QD) of prednisone (or equivalent) to maintain haemoglobin levels of \\>8.0 g\u002FdL or platelets \\> 10,000 mL without transfusion support.\n* History of transformation of CLL to aggressive non-Hodgkin lymphoma (Richter´s transformation or pro-lymphocytic leukaemia) which may otherwise interfere with the interpretation of the outcome of the study (including biomarker evaluation).\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia or fatigue. Any irAEs from prior immunotherapy must have complete resolution and must have resolved at least 2 weeks before Cycle1 Day1.\n* Participants who are receiving any other investigational agents for this condition.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to roginolisib or venetoclax or their formulation components or prior anti- CD20 targeting agents more than 6 months before initiating study treatments.\n* Patients with a history of systemic autoimmune disease.\n* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A are ineligible. Moderate CYP3A inhibitors and P-gp inhibitors can be administered when venetoclax dose is reduced to 50%. Otherwise, venetoclax is contraindicated in patients requiring strong or moderate CYP3A inducers.\n\n  * Because of ongoing research, regularly consulting medical reference databases is recommended. One such reference is the Website of the US-FDA: (Drug Interactions \\| Relevant Regulatory Guidance and Policy Documents \\| FDA)\n  * 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* Pregnant women are excluded from this study because venetoclax has the potential to cause embryo-fetal harm, and the potential for teratogenic or abortifacient effects with roginolisib is currently unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with roginolisib or venetoclax breastfeeding should be discontinued if the mother is treated with these agents.\n* Patients with a history of other primary malignancy are excluded when they require therapy that will interfere with the investigational treatments. Exceptions are if the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen. For example:\n\n  * Malignancies surgically treated with curative intent and with no known active disease present for ≥2 years before the first dose of study treatment.\n  * Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated cervical carcinoma in situ without evidence of disease.\n  * Surgically\u002Fadequately treated low-grade, early-stage, localized prostate cancer without evidence of disease or low risk localized prostate cancer on observation.\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n* History or presence of cardiovascular disease, which in the Investigator's opinion may impact the clinical trial participation. Patients with a QTcF \\> 470 msec at screening.\n* History of tuberculosis treatment within the preceding two years.\n* Ongoing systemic bacterial, fungal, or viral infections (including also hepatitis viral infection) at the time of initiation of study treatment (defined as requiring intravenous \\[IV\\] antimicrobial, antifungal or antiviral agents). Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion\u002Fexclusion criteria are met, there is no evidence of active infection at enrollment, and ongoing treatment does not have a significant risk of drug-drug interaction with venetoclax.\n* Known Human immunodeficiency virus (HIV) infection which is treated with agents that can interfere with venetoclax due to potential drug-drug interactions or increased risk of myelotoxicity.\n* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.\n* Known alcohol or substance abuse.",{"count":212,"type":21},64,[24,25],"This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).\n\nThe names of the study drugs involved in this study are:\n\n* Roginolisib (a novel type of PI3-kinase delta inhibitor)\n* Venetoclax (a type of B-cell lymphoma 2 inhibitor)\n* Rituximab (a type of monoclonal antibody)",[216,217,218,30,219],"Leukemia","Relapsed Leukemia","Chronic Lymphocytic Leukemia","Refractory Leukemia",[216,217,218,30,219,221,222,223],"CLL","Relapsed Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","2026-02-09",{"date":226,"type":54},"2026-02-11",{"date":228,"type":54},"2025-03-19",{"date":230,"type":21},"2032-10-01",{"name":232,"class":98},"Jennifer R. Brown, MD, PhD",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100510135","phase-2-isatuximab-bela-maf-pom-and-dex-in-relapsedrefractory-multiple-myeloma-100510135","NCT05922501","Isatuximab, Bela Maf, Pom, and Dex in Relapsed\u002FRefractory Multiple Myeloma","A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma","ISABELA","Inclusion Criteria:\n\n* Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).\n* Age ≥ 18 years\n* Measurable disease of multiple myeloma as defined by at least one of the following:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\n  * Involved serum free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free light chain ratio\n* Previously treated relapsed and refractory multiple myeloma:\n* Patients must have received at least one prior line of therapy;\n* Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen); and\n* Disease progression on or within 60 days of completion of last therapy.\n* ANC ≥ 1000\u002FμL. G-CSF is not permitted within 14 days of screening. Patients with ANC \\\u003C1000\u002FµL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from the PI.\n* Platelet count ≥ 75,000\u002FµL. Platelet transfusion is not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula\n* Spot urine (albumin\u002Fcreatinine ratios (spot urine) \\\u003C 500 mg\u002Fg or urine dipstick negative\u002Ftrace.\n* Patient has adequate hepatic function, as evidenced by each of the following:\n* Serum bilirubin values \\\u003C 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and\u002For aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin).\n* Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.\n* All study participants must be registered into the mandatory Pomalyst REMS program and be willing and able to comply with the requirements of the Pomalyst REMS program.\n* Women of childbearing potential (WOCBP) must adhere to the scheduled pregnancy testing as required in the Pomalyst REMS program and agree to use a highly effective method of contraception during the study for 4 months after the last dose of treatment in the study (see Appendix) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period). A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before the first dose of study intervention and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin. Note: non childbearing potential defined as follows (by other than medical reasons):\n\n  * ≥ 45 years of age and has not had menses for \\> 1 year\n  * Patients who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n* A man who is sexually active with a WOCBP (even if they have undergone a successful vasectomy) must agree to use a barrier method of birth control e.g. either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository for 6 months after receiving the last dose of study drug.\n* Male participants must refrain from donating sperm for 6 months after the last dose of study drug.\n* Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).\n\nExclusion Criteria:\n\n* Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.\n* Participant must not use contact lenses while participating in this study.\n* Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.\n* Participants who are receiving any investigational agents.\n* Prior therapy with anti-CD38 monoclonal antibody within six months. No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment.\n* Prior therapy with anti-BCMA therapy.\n* Plasmapheresis within seven days prior to start of study treatment.\n* Primary refractory disease.\n* Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg\u002Fday or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.\n* Pregnancy or lactation or planned lactation (breastfeeding).\n* Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥ 3 years. Patients who are free of disease \\\u003C 3 years may enroll after discussion with and approval of the PI. Exceptions include the following (i.e. the following are eligible to participate):\n\n  * Basal or squamous cell carcinoma of the skin\n  * Carcinoma in situ of the cervix\n  * Ductal carcinoma in situ of the breast\n  * Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance\n* Patients with active plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.\n* Seropositive for HIV infection\n* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]; see exception below). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened for hepatitis B virus (HBV) DNA levels. Those with positive HBV viral load will be excluded. Exception: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need testing for HBV DNA.\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).\n* Peripheral neuropathy ≥ grade 2 despite supportive therapy.\n* Hypersensitivity to isatuximab, belantamab mafodotin, pomalidomide, or dexamethasone, such as Stevens-Johnson syndrome. Rash to immunomodulatory drug that can be medically managed is allowed.\n* Allogeneic stem cell transplant \\\u003C12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD).\n* Autologous stem cell transplant \\\u003C6 months prior to start of treatment\n* Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:\n\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n  * Unstable angina\n  * Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block\n  * Recent (within the preceding 6 months) myocardial infarction or stroke\n  * Uncontrolled hypertension\n  * Diabetes mellitus with \\> 2 episodes of ketoacidosis in the preceding 12 months\n  * Chronic obstructive pulmonary disease (COPD) requiring \\> 2 hospitalizations in the preceding 12 months.\n  * Unstable liver or biliary disease\n  * Active bacterial, viral, or fungal infection\n* Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.\n* Major surgery within 4 weeks prior to C1D1.\n* Live or live-attenuated vaccine within 30 days prior to C1D1.\n* Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.",{"count":134,"type":21},[25],"The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.",[30,245,246],"Refractory Multiple Myeloma","Multiple Myeloma",[248,246,249],"Relapsed\u002FRefractory","Relapsed and Refractory","2026-01-12",{"date":252,"type":54},"2026-01-14",{"date":254,"type":54},"2024-05-31",{"date":256,"type":21},"2030-12-31",{"name":258,"class":98},"Massachusetts General Hospital",2,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":62},"100535380","phase-4-plan-development-for-giving-teclistamab-in-the-outpatient-setting-100535380","NCT06251076","Plan Development for Giving Teclistamab in the Outpatient Setting","Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed\u002FRefractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden","Multiple Myeloma Patients to Receive Outpatient Teclistamab (Part 1):\n\nInclusion Criteria:\n\n1. Eligible for teclistamab treatment as per Health Canada approved indication:\n\n   1. Age 18 and greater\n   2. Relapsed or refractory multiple myeloma\n   3. Received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody\n   4. Demonstrated disease progression on the last therapy\n2. For Cohorts 1 and 2, participants must agree to receive treatment at Princess Margaret Cancer Centre. For Cohort 3, participants must agree to receive treatment at Stronach Regional Cancer Centre.\n3. Must sign the informed consent form (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.\n4. Have one or more caregivers meeting study criteria.\n5. Have clinical laboratory values meeting study criteria.\n6. Rockwood Clinical Frailty Scale - threshold score ≤ 5\n7. A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and must agree to:\n\n   1. Practicing true abstinence; or\n   2. Have a sole partner who is vasectomized; or\n   3. Practicing ≥1 highly-effective, user-independent method of contraception.\n8. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study. Upon study end, female participants must agree to continue with product monograph guidelines with ongoing teclistamab off-study.\n9. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study, and thereafter to continue with product monograph guidelines. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the study, and thereafter to follow product monograph guidelines with ongoing teclistamab off-study.\n\nExclusion Criteria:\n\n1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.\n2. Prior or concurrent exposure to any of the following:\n\n   1. Teclistamab or any anti-BCMA therapy\n   2. Other myeloma therapy (standard of care or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab\n3. Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n4. High risk disease features including:\n\n   1. Central nervous system (CNS) involvement with myeloma\n   2. Extramedullary disease (≥1 soft tissue plasmacytoma not associated with bone)\n   3. Circulating plasma cells (plasma cell leukemia)\n   4. Rapidly progressive disease, as per investigator assessment\n5. Concurrent disorders, including:\n\n   e. Light chain amyloidosis f. Second malignancy requiring active therapy, exceptions including prostate cancer receiving androgen deprivation therapy or adequately treated breast cancer carcinoma on anti-hormonal agents and considered to have a very low risk of recurrence g. Underlying neurologic dysfunction (history of seizure, Cerebrovascular Accident (CVA) or Transient ischemic attack (TIA), intracranial hemorrhage, dementia or other cognitive impairment) h. Hepatitis B infection (HBV-DNA positive). Patients with HepBsAg (Surface antigen of Hepatitis B virus) or HepBcAb (Hepatitis B viral protein) positive are allowed on study, only if on antiviral prophylaxis and HBV-DNA viral load is undetectable.\n\n   i. Active infection requiring anti-infective therapy (prophylactic antibiotics are allowed). Cytomegalovirus (CMV) IgG (Immunoglobulin G) positivity allowed, but must be CMV PCR (Polymerase Chain Reaction) negative.\n\n   j. Underlying coagulopathy that may increase the risk of bleeding in the setting of cytopenia.\n6. Presence of the following cardiac conditions:\n\n   1. New York Heart Association stage III or IV congestive heart failure\n   2. Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization\n   3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n   4. History of severe non-ischemic cardiomyopathy\n7. Major surgery within 2 weeks prior to the start of administration of study treatment (kyphoplasty or vertebroplasty are not considered major surgery).\n8. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n\n   1. Uncontrolled diabetes\n   2. Acute diffuse infiltrative pulmonary disease\n   3. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy\n   4. History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing\n   5. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status\n   6. Other comorbidities felt by treating physician to require hospitalization for teclistamab step-up dosing, such as poorly controlled pain despite use of narcotics, multiple concurrent comorbidities (diabetes, advanced age, cardiac disease)\n   7. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n   8. History of non-compliance with recommended medical treatments\n\nCaregivers of multiple myeloma subjects treated with outpatient-based teclistamab (Part 2):\n\nInclusion Criteria:\n\n1. Agree to be a caregiver for a participant with multiple myeloma enrolled in this study protocol to receive outpatient teclistamab (any of Cohorts 1, 2, 3)\n2. Age 18 and greater\n3. English-speaking\n4. Must sign an Informed consent form\n5. Attend mandatory orientation, equipment training, and provide transportation by car to and from Princess Margaret Cancer Centre until two days after completion of first three doses (at minimum 8 days to encompass step up dosing), and twice weekly to Day 27\n6. Accompany the participant through the night and during the day, with no more than 2-hour gaps during the day during which the patient is alone, to end of study (Day 27 or completion of 6 total doses \\[2 step up doses + 4 full doses\\], whichever is later). More than one caregiver may participate to fill the required hours of accompaniment.\n7. Agree to help administer home medications, buy groceries, prepare food and otherwise support the participant\n8. Agree and capable of monitoring the participants vital signs, apply the Immune Effector Cell Encephalopathy (ICE) score, record findings, and report to the study team (by phone or in person)\n\nExclusion Criteria:\n\n1. Not sufficiently comfortable or understanding of the use of vital sign equipment, applying the ICE score, or other caregiver requirements, as per Investigator discretion\n2. Unable to complete caregiver follow-up assessments at 30 and 90 days after last treatment subject dose.",{"count":166,"type":21},[269],"PHASE4","This is a pilot study to develop an outpatient-based process for the administration of teclistamab for for relapsed\u002Frefractory multiple myeloma patients and to evaluate the burden on caregivers of patients receiving outpatient administration of teclistamab.",[246,30,88],"2025-12-02",{"date":274,"type":54},"2025-12-10",{"date":276,"type":54},"2024-11-19",{"date":278,"type":21},"2026-10",{"name":97,"class":98},{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":289,"phases":4,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":62},"100549162","study-of-metabolic-transcriptomic-and-proteomic-characteristics-in-relapsed-glioblastoma-100549162","NCT06430424","Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma","Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.","GBrecurr","Inclusion Criteria:\n\n* age \\> 18 years\n* surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux\n\nExclusion Criteria:\n\n* systemic therapy received for non-glioblastoma tumor",{"count":20,"type":21},"OBSERVATIONAL","Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.",[30,29],[293,294,295,296,297,298],"Recurrent glioblastoma","Prognostic","Metabolism","Proteomic","Transcriptomic","Microbiota","2025-07-29",{"date":301,"type":54},"2025-07-30",{"date":303,"type":54},"2024-04-05",{"date":305,"type":21},"2026-04",{"name":307,"class":98},"University Hospital, Bordeaux",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":315,"maxAge":17,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":323,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":62},"100383626","three-times-weekly-symptom-screening-for-children-with-cancer-100383626","NCT04275102","Three Times Weekly Symptom Screening for Children With Cancer","A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer","Inclusion Criteria:\n\n* cancer diagnosis\n* 2-18 years of age at enrollment\n* Child has received or a plan for any chemotherapy, radiotherapy or surgery\n* Understands English, French or Spanish\n\nExclusion Criteria:\n\n* Cognitive disability\n* Visual impairment (cannot see SPARK even with corrective lens)","2 Years",{"count":317,"type":21},30,[319],"NA","This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and\u002For their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.",[322,30],"Cancer","NOT_YET_RECRUITING","2025-05-12",{"date":326,"type":54},"2025-05-15",{"date":328,"type":21},"2025-08-01",{"date":330,"type":21},"2025-11-29",{"name":332,"class":98},"The Hospital for Sick Children",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":16,"minAge":341,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":364,"leadSponsor":366,"locationsCount":62},"100462467","phase-1-allogeneic-nkg2dl-targeting-car--t-cells-ctm-n2d-in-advanced-cancers-angelica-100462467","NCT05302037","Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)","A Phase I Trial to Evaluate Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) in Subjects With Advanced Solid Tumours or Haematological Malignancies (the ANGELICA Trial)","ANGELICA","Inclusion Criteria:\n\n* At least 21 years of age\n* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling, and analyses (if applicable, the written informed consent may include access to all archival tumour tissue, e.g., diagnostic and\u002For most recent samples for correlative study)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and an estimated life expectancy of greater than 12 weeks\n* Females of reproductive age group must be on effective contraception (if sexually active), must not be breast feeding and must have a negative pregnancy test prior to the start of lymphodepletion.\n* For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception (i.e., condoms) with all sexual partners. Where the sexual partner is a 'woman of child-bearing potential' who is not using effective contraception, the male patients must use a condom (with spermicide) during the study and for 6 months after the last dose of a study drug.\n* Adequate hepatic, renal and lung function as demonstrated by any of the following laboratory values:\n\n  * AST or ALT ≤ 3 x ULN\n  * Total bilirubin ≤ 1.5 x ULN\n  * Glomerular filtration rate (GFR) \\> 50 mL\u002Fmin, as assessed using the Cockroft-Gault formula or 24 h urine creatinine collection\n  * SpO2 on room air \\> 94%\n* Adequate bone marrow reserve as demonstrated by any of the following laboratory values:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0x10\\^9\u002FL\n  * Platelet count ≥ 75 x 10\\^9\u002FL\n  * Haemoglobin ≥ 9.0 g\u002FdL\n* Patients must have a metastatic cancer resistant to or deemed unsuitable for at least two standard lines of cancer therapy regimens, as part of their management of recurrent\u002Fpersistent disease.\n* Presence of measurable tumour by RECIST 1.1 criteria\n* Serum 25 Hydroxyvitamin D total ≥ 20ng\u002Fml\n* Have a diagnosis of cancer that is known to express NKG2D ligands\n\nExclusion Criteria:\n\n* With the exception of alopecia, any unresolved toxicities from prior therapy ≥ the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 2\n* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to the start of lymphodepletion\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection including any patient known to have human immunodeficiency virus (HIV) or hepatitis virus. Screening for chronic conditions is not required.\n* All HBsAg-positive patients (For HBsAg-negative, but anti-HBc total-positive patients, HBV viral load will be further tested. If HBV viral load is negative, patients may be included.)\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Subjects without active disease in the last 5 years may be included but only after consultation with the medical monitor\n  * Subjects with celiac disease controlled by diet alone\n  * For other autoimmune or inflammatory conditions not specifically mentioned, discuss on case-by-case basis with investigator and medical monitor\n* Concurrent severe and\u002For uncontrolled medical condition (e.g., severe COPD, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition (screening for chronic disease is not required)\n* Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of contraception\n* Receiving, or having received during the four weeks prior the start of lymphodepletion, any investigational product\n* Treatment with any investigational biological product (e.g., immune check point blockers, antibodies, nanoparticles, experimental) during the four weeks prior the start of lymphodepletion\n* Patients who underwent major surgery during the four weeks prior to the start of lymphodepletion\n* Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) during the three weeks prior to the start of Lymphodepletion\n* Active infection requiring systemic long-term (\\> 2 weeks) treatment with antibiotics, antifungal or antiviral drugs\n* Cardiac dysfunction as defined as: Myocardial infarction within six months of study entry, NYHA Class II\u002FIII\u002FIV heart failure, unstable angina, unstable cardiac arrhythmias or reduced LVEF \\\u003C 50%.\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)\n  * Uncontrolled hypertension requiring clinical intervention\n* Failed dental clearance (for zoledronic acid administration)\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements\n\nSubject Withdrawal Criteria\n\nTreatment may continue until one of the following criteria applies:\n\n* Disease progression\n* Intercurrent illness that prevents further administration of treatment\n* Unacceptable adverse event(s)\n* Intolerable non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 2\n* Unmanageable hematologic or non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 3\n* General or specific changes in the patient's condition that renders the patient unsuitable for further treatment at the discretion of the investigator\n* Patient who cannot recover from adverse event(s) and lead to treatment delay for \\> 4 weeks\n* Patient who decides to withdraw from the study","21 Years",{"count":343,"type":21},12,[24],"CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells.\n\nCurrently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy.\n\nCytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not.\n\nThe phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D.\n\nCTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.",[322,347,88,30],"Malignancy",[349,350,351,352,353,354,355,356,357,358,359],"cancer","malignancy","solid cancer","solid tumours","haematological cancer","haematological malignancy","refractory cancer","relapsed cancer","CAR-T","cell therapy","gamma delta","2024-11-20",{"date":362,"type":54},"2024-11-22",{"date":276,"type":54},{"date":365,"type":21},"2026-12",{"name":367,"class":133},"CytoMed Therapeutics Pte Ltd",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":375,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":289,"phases":4,"briefSummary":379,"conditions":380,"keywords":385,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100478038","precision-medicine-for-every-child-with-cancer-100478038","NCT05504772","Precision Medicine for Every Child With Cancer","ZERO2","Inclusion Criteria:\n\n1. Age \\\u003C 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.\n2. Life expectancy \\>6 weeks at time of enrolment\n3. Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent\u002Fguardian of participant aged \\\u003C18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.","0 Years","25 Years",{"count":378,"type":21},3500,"To improve outcomes for childhood cancer patients through the implementation of precision medicine.",[381,382,383,384,88,30],"Childhood Cancer","Childhood Solid Tumor","Childhood Brain Tumor","Childhood Leukemia",[386,387,388,389,390,391],"children","precision medicine","personalised medicine","molecular profiling","pediatric","paediatric","2024-07-16",{"date":394,"type":54},"2024-07-17",{"date":396,"type":54},"2022-12-16",{"date":398,"type":21},"2030-07",{"name":400,"class":98},"Australian & New Zealand Children's Haematology\u002FOncology Group",11]