[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-hematologic-malignancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-hematologic-malignancy":22},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,37,84,112,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100494056","long-term-follow-up-after-adoptive-transfer-of-genetically-modified-cell-products-100494056",false,"NCT05713214","Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products","Inclusion Criteria:\n\n* Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.\n\nExclusion Criteria:\n\n* Inability or unwillingness of research participant and\u002For legal guardian\u002F representative to give written informed consent.","ALL",{"count":17,"type":18},500,"ESTIMATED","OBSERVATIONAL","Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body. With this genetic modification comes risk of undesirable adverse events. Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that meet defined criteria. This protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a St. Jude initiated study.",[22,23],"Relapsed Hematologic Malignancy","Refractory Hematologic Malignancy","RECRUITING","2026-06-15",{"date":27,"type":28},"2026-06-17","ACTUAL",{"date":30,"type":28},"2023-02-08",{"date":32,"type":18},"2052-12-01",{"name":34,"class":35},"St. Jude Children's Research Hospital","OTHER",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100310953","phase-1-ca-4948-101-open-label-dose-escalation-and-expansion-trial-of-emavusertib-ca-4948-in-relapsed-or-refractory-primary-central-nervous-system-lymphoma-rr-pcnsl-100310953","NCT03328078","CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R\u002FR PCNSL)","An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Males and females greater than or equal to 18 years of age\n2. Life expectancy of at least 3 months\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n4. Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL.\n\n   1. Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion \\[≥ 10 millimeters (mm) and ≤ 40 mm in the longest diameter on brain magnetic resonance imaging \\[MRI\\] or head computed tomography \\[CT\\] on imaging within 28 days prior to Cycle 1 Day 1\\]). In cases where the tumor size is smaller but still measurable and located at a critical central nervous system (CNS) location, disabling the participant and\u002For causing symptoms, this participant may be eligible following a discussion with the Sponsor Medical Monitor.\n   2. For participants limited to leptomeningeal involvement, cerebrospinal fluid (CSF) analysis (cytology and\u002For flow cytometry) with or without additional imaging (MRI) of the spine as clinically indicated is required to document abnormal cells within 28 days prior to Cycle 1 Day 1.\n\nExclusion Criteria for Part B and Part C\n\n1. Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma metastatic to the CNS\n2. Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the chest, abdomen, and pelvis at Screening (testicular ultrasound may be considered to exclude a testicular lymphoma disseminated to the brain).\n3. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) or prior history of systemic lymphoma, unless the participant has been free of the disease for ≥ 3 years.\n4. Active malignancy other than PCNSL requiring systemic therapy\n5. Previous BTKi treatment (Part C only).\n6. History of Grade ≥ 3 rhabdomyolysis without complete recovery\n7. Requirement for urgent therapy due to uncontrolled tumor mass\u002Fedema effects.\n8. Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1.\n9. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to Cycle 1 Day 1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing up-titration of immunosuppressive medications prior to Screening (with the exception of a BTKi for Part B only).\n\n   Note: The use of a stable or tapering dose of immunosuppressive therapy post-HSCT and\u002For topical steroids for ongoing skin GVHD is permitted with Sponsor Medical Monitor approval\n10. Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1)\n11. Prior history of hypersensitivity or anaphylaxis to emavusertib, ibrutinib or any of their excipients.","18 Years",{"count":46,"type":18},152,"INTERVENTIONAL",[49,50],"PHASE1","PHASE2","This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R\u002FR) hematologic malignancies.\n\nThis trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete).\n\nPart B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R\u002FR primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles.\n\nPart C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R\u002FR PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R\u002FR PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.",[22,23,53,54],"Relapsed Primary Central Nervous System Lymphoma","Refractory Primary Central Nervous System Lymphoma",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"MYD88","IRAK4","NHL","PCNSL","Lymphoma","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Lymphoma, Non-Hodgkin","Relapsed\u002Frefractory Central Nervous System (CNS) Lymphoma","Systemic Lymphoma with Concurrent CNS Lymphoma","Systemic Lymphoma with a History of Treated CNS Lymphoma","Ibrutinib","Bruton tyrosine kinase inhibitor (BTKi)","Primary CNS Lymphoma","2026-04-15",{"date":75,"type":28},"2026-04-16",{"date":77,"type":28},"2017-12-28",{"date":79,"type":18},"2026-10",{"name":81,"class":82},"Curis, Inc.","INDUSTRY",45,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":15,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100460013","international-leukemia-target-board-100460013","NCT05270096","International Leukemia Target Board","International Concerted Action to Allocate Children, Adolescents and Young Adults With Relapsed and Refractory Leukemia\u002FLymphoma to the Right Therapy.","iLTB","Inclusion criteria\n\n1. The patient has been diagnosed with a R\u002FR hematological malignancy;\n2. The patient is less than 18 years of age at the time of first diagnosis and less than 25 years at the time of inclusion with relapse\u002Frefractory hematological malignancy;\n3. The patient is treated in a pediatric\u002FAYA setting or study protocol, with no current standard of care treatment;\n4. The patients' life expectancy is at least 6 weeks;\n5. The patient has undergone any sort of molecular profiling of his\u002Fher tumor and the re-sults of this analysis are available;\n6. The patient has undergone flow cytometry in a certified lab and results are available;\n7. Written informed consent of patient and\u002For parent(s)\u002Fguardian(s) to discuss the patient in the iLTB according to local law and legislation has been obtained.\n\nExclusion criteria: none defined","0 Years","25 Years",{"count":95,"type":18},600,"The iLTB is a proof-of-concept initiative for children with r\u002Fr hematological malignancies, in which available treatment options will be prioritized by actionable events in a harmonized and uniform setting across Europe by a team of biologists, bio-statisticians, bio-informaticians, disease experts, geneticists, flow-experts, clinical trial physicians and also the treating physician.\n\nThe iLTB will discuss molecular (genetic lesions), immunophenotypic\u002Fsurface antigen markers information and, if available, drug response profiles to prioritize these events taking into account the treatment history and treatment intention (bridging to hematopoietic stem cell transplanation\u002FCAR-T or palliative) of each patient followed by a registry to monitor how often iLTB advice has been followed, which other therapy was chosen (off-label, compassionate use) and what the patient outcome is at an aggregated level.\n\nAs such the iLTB is non-interventional as it mainly provides advice and registers data on patients discussed in the iLTB.",[22,23],[99,100,101],"Tumor board","Relapsed leukemia","Treatment prioritization","2026-01-07",{"date":104,"type":28},"2026-01-09",{"date":106,"type":28},"2022-12-31",{"date":108,"type":18},"2032-06-01",{"name":110,"class":35},"Princess Maxima Center for Pediatric Oncology",7,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":47,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":36},"100512746","pro-and-wearable-data-insights-from-individuals-with-rr-multiple-myeloma-100512746","NCT05956457","PRO and Wearable Data Insights From Individuals With R\u002FR Multiple Myeloma","Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18 or older\n2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.\n3. Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and\u002For one immunomodulatory drug (IMiD).\n\nExclusion Criteria:\n\n1. Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)\n2. Individuals who have previously participated in Pack Health digital health coaching\n3. Physician-assessed lack of sufficient English proficiency\n4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application\n5. Any serious and\u002For unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures\n6. Concurrent enrollment on a therapeutic study in R\u002FR MM that precludes simultaneous enrollment onto our non-therapeutic study",{"count":120,"type":18},100,[122],"NA","This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R\u002FR MM). One hundred adults with R\u002FR MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R\u002FR MM.",[125,22],"Multiple Myeloma",[127,128,129],"Digital health","Patient reported outcomes","Wearable Activity Trackers","2025-04-16",{"date":132,"type":28},"2025-04-20",{"date":134,"type":28},"2023-09-15",{"date":136,"type":18},"2026-08-31",{"name":138,"class":82},"Pack Health",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":47,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100563363","phase-1-a-study-of-hdm2005-in-patients-with-relapsedrefractory-b-cell-lymphoma-and-advanced-solid-tumor-100563363","NCT06615193","A Study of HDM2005 in Patients With Relapsed\u002FRefractory B-cell Lymphoma and Advanced Solid Tumor","A Phase Ia\u002FIb, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HDM2005 in Patients With Relapsed\u002FRefractory B-cell Lymphoma and Advanced Solid Tumor","Inclusion Criteria:\n\n1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;\n2. Male or female aged ≥ 18 years at the time of signing the ICF;\n3. B-cell lymphoma: ECOG performance status of 0-2;\n4. Advanced solid tumors: ECOG performance status of 0-1;\n5. Life expectancy of at least 3 months;\n6. Dose escalation phase: Histopathologically confirmed relapsed\u002Frefractory B-cell lymphoma following at least 2 prior lines of systemic therapy;\n7. Dose expansion phase: relapsed\u002Frefractory B-cell lymphoma and advanced or metastatic solid tumor of specified type.\n8. All subjects are required to provide archived tissue (5 unstained sections) obtained within the previous 2 years or fresh tissue for ROR1 expression testing at the central laboratory; in addition, relapsed\u002Frefractory lymphoma subjects are required to provide tissue sections used for previous pathological diagnosis for pathological consultation at the central laboratory;\n9. Relapsed\u002Frefractory B-cell lymphoma: Subjects in Phase Ia dose escalation phase should have evaluable lesions; subjects in Phase Ib dose expansion phase should have at least 1 radiographically measurable lymph node or extranodal malignant tumor lesion (intranodal lesion defined as having a long diameter \\> 1.5 cm; extranodal lesion having a long diameter \\> 1.0 cm) as assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) according to 2014 Lugano criteria, and a lesion that has previously received radiotherapy is considered measurable when it shows unequivocal progression after completion of radiotherapy;\n10. Advanced solid tumors: subjects are required to have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 ;\n11. Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy;\n12. Subjects have adequate organ and bone marrow function;\n13. Female subjects of childbearing potential should agree to use contraception methods (e.g., intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days before study enrollment; and male subjects should agree to use contraceptive avoidance measures during the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. B-cell lymphoma: known central nervous system (CNS) involvement .\n2. Advanced solid tumors: Patients with active brain metastases (defined as stable for \\\u003C 4 weeks, or symptomatic, or requiring antiepileptic drug\u002Fhormonal therapy, or meningeal metastases);\n3. Subjects with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by ≥ Grade 2 serum bilirubin, ≥ Grade 3 skin involvement, or ≥ Grade 3 diarrhea or receiving systemic immunosuppressive therapy\u002Fprophylaxis for GVHD);\n4. Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al;\n5. History of severe bleeding disorders ;\n6. History of chronic pancreatitis or acute pancreatitis within 6 months;\n7. History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease;\n8. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage, VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled);\n9. Prior solid organ transplantation;\n10. Persistent peripheral neuropathy \\> Grade 1 at baseline;\n11. Clinically significant cardiovascular or cerebrovascular diseases;\n12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic therapy (except for localized skin or nail bed fungal infection) at enrollment;\n13. Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis;\n14. Receiving corticosteroids (prednisone equivalent more than 30 mg\u002Fday);\n15. Contraindication to any component of HDM2005;\n16. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma\u002FCOPD;\n17. Female subjects who are pregnant, lactating or planning to become pregnant during the study;\n18. Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements;\n19. Prior or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, could affect the outcome of the study, prevent the subject from participating in the study entirely, or is not in the subjects' best interest.",{"count":147,"type":18},111,[49],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed\u002Frefractory B-cell lymphoma and advanced solid tumors.",[151,152,22],"Advanced Solid Tumors","Refractory Lymphoma","2024-09-23",{"date":155,"type":28},"2024-09-26",{"date":157,"type":28},"2024-08-12",{"date":159,"type":18},"2028-02-01",{"name":161,"class":82},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",8]