[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoproliferative-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoproliferative-disorders":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,49,75,123,146,189,218,257,282,301,359,388,413,438,460,480,508],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100356570","phase-2-allogeneic-hematopoietic-cell-transplantation-for-peripheral-t-cell-lymphoma-100356570",false,"NCT03922724","Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma","Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma","* INCLUSION CRITERIA-RECIPIENT:\n* Age \\>=12 years\n* Diagnosis of PTCL, confirmed by NCI pathology review, that is relapsed or refractory to prior therapy, and\u002For PTCL where upfront allo HCT in first remission is reasonable (PIT score of intermediate-low risk or higher or supported by clinical practice guidelines)\n\n  --ALK-positive ALCL patients will only be eligible if relapsed or refractory\n* At least one potential 7-8\u002F8 HLA-matched related (excluding an identical twin) or unrelated donor (at HLA-A, -B, -C, and DR), or an HLA-haploidentical related donor, based on initial low resolution unrelated donor search and\u002For at least one biologically-related family member who has at least a 25% chance of being at minimum an HLAhaploidentical match and is potentially suitable to donate based on reported family history. HLA typing of potential donors and\u002For mutation testing does not need to be completed for eligibility.\n* Adequate end-organ function, as measured by:\n\n  * For RIC: Left ventricular ejection fraction (LVEF) \\>= 40% by 2D echocardiogram (ECHO) or MUGA, left ventricular shortening fraction \\>= 20% by ECHO, or LVEF \\>= 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis. For IOC: LVEF \\>= 30% by 2D ECHO or MUGA.\n  * Pulmonary function tests: DLco (corrected for hemoglobin) and FEV1 \\>= 40% of predicted for the RIC arm, and \\>= 30% predicted for the IOC arm; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92% on room air.\n  * Bilirubin \\\u003C= 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis) for patients receiving RIC and bilirubin \\\u003C= 5.0 mg\u002FdL for patients receiving IOC (unless due to Gilbert s syndrome or hemolysis); ALT and AST \\\u003C= 10 x ULN for patients receiving RIC or IOC. Patients who are above these bilirubin, ALT, or AST thresholds may be eligible for the RIC or IOC arm if evaluated by a hepatologist who deems the liver function test abnormalities to be potentially disease related, either because of direct involvement by PTCL, due to an associated process such as hemophagocytic lymphohistiocytosis, or as sequelae of prior chemotherapy that is thought to improve with time.\n  * Estimated creatinine clearance of \\>= 50 mL\u002Fmin\u002F1.73 m\\^2, calculated using eGFR in the clinical lab for adults and the Schwartz formula for pediatrics.\n* Karnofsky (adults) or Lansky (children) performance status of \\>= 50% or ECOG performance status of 2 or less for the RIC arm and Karnofsky (adults) or Lansky (children) \\>= 30% or ECOG performance status of 3 or less for the IOC arm\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document\n* Not pregnant or breastfeeding.\n* As therapeutic agents used in this trial may be harmful to a fetus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-allo HCT.\n\nEXCLUSION CRITERIA-RECIPIENT:\n\n* Patients who are receiving any other investigational agents, with the exception of virus-specific cytotoxic T-cells for the treatment of viral infection\u002Freactivation prior to allo HCT.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (e-ATG, steroids, cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or biosimilar drug) used in the study\n* Lack of central venous access potential\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol or which does not allow for appropriate informed consent\n\nINCLUSION CRITERIA-RELATED DONOR:\n\n-Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood and\u002For peripheral blood stem cells for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n\nEXCLUSION CRITERIA-RELATED DONOR:\n\nNone\n\nINCLUSION CRITERIA (UNRELATED DONOR):\n\n-Unrelated donors will be evaluated in accordance with existing NMDP Standard Policies and Procedures, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobal-transplantnetwork\u002F Standards\u002F, except for the additional requirement of EBV serostatus testing for clinical purposes of donor selection. Note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study. Unrelated donors only enroll if they contribute research specimens, which is optional.\n\nEXCLUSION CRITERIA (UNRELATED DONOR):\n\n-Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP Standards, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobaltransplant- network\u002FStandards\u002F. Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not automatically exclude the donor and will be reviewed by the PI.",true,"ALL","12 Years","120 Years",{"count":21,"type":22},330,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nLymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause.\n\nObjective:\n\nTo test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects.\n\nEligibility:\n\nRecipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments\n\nDonors: Healthy people ages 18 and older whose relative has lymphoma\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nBlood and urine tests\n\nBone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow.\n\nDonors will also be screened with:\n\nX-rays\n\nRecipients will also be screened with:\n\nLying in scanners that take pictures of the body\n\nTumor sample\n\nDonors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm.\n\nRecipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy.\n\nRecipients will get the transplant through their catheter.\n\nRecipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months.\n\nRecipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.",[28,29,30],"Peripheral T-cell Lymphomas","Lymphoproliferative Disorders","Immune System Diseases",[32,33,34,35],"Autoimmunity","Immune Dysregulation","Congenital","Opportunistic Infection","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2019-04-18",{"date":44,"type":22},"2030-10-31",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100253594","phase-2-pilot-trial-of-allogeneic-blood-or-marrow-transplantation-for-primary-immunodeficiencies-100253594","NCT02579967","Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies","* INCLUSION CRITERIA - RECIPIENT:\n* Patients age \\>= 4 through 75 years\n* PID deemed to be of sufficient past severity to warrant allo BMT, by meeting the two criteria below:\n\n  1. PID as defined by identified genetic defect or, in the absence of a PID-associated genetic mutation, patients with an immune defect potentially amenable to allo BMT who meet the clinical history criteria below may be eligible upon discussion with the PI\n\n     * Mutations should be confirmed in a CLIA-certified laboratory, if such testing is available.\n     * Patients without a mutation must be deemed eligible and appropriate for allo BMT by the PI. Some patients may meet the clinical history criteria listed below, but will not be eligible if it is thought that their clinical history is due to a condition apart from an immune defect. In addition, patients with a PID of mild severity, such as those with selective IgA deficiency, may meet at least two of the clinical history criteria, but may be deemed inappropriate for allo BMT by the PI if it is felt that the risks of the procedure outweigh the severity of the disease.\n  2. Clinical history of at least two of the following:\n\n     * Life-threatening, organ-threatening, or severely disfiguring infection\n     * Protracted or recurrent infections requiring unusually long or repeated courses of antibiotics\n     * Infection with an opportunistic organism\n     * Chronic elevation in the blood (\\>=2 documented elevations over a period of 6 months or longer) of a latent virus (EBV, CMV, HHV6, HHV8, etc.)\n     * Evidence of immune dysregulation, as manifested by autoimmune disease, atopy, hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome, granulomas, splenomegaly, or lymphadenopathy\n     * Patients with hemophagocytic lymphohistiocytosis or macrophage activation syndrome related to an underlying lymphoma with no other clinical history suggestive of a primary immunodeficiency will not be eligible\n     * Hypogammaglobulinemia, dysglobulinemia, or impaired response to vaccination\n     * Hematologic malignancy or lymphoproliferative disorder\n     * Tissue diagnosis should be confirmed by NCI Department of Pathology, if prior biopsies are available\n     * Virus-associated solid tumor malignancy or pre-cancerous lesion\n     * Tissue diagnosis should be confirmed by NCI Department of Pathology, if prior biopsies are available\n* Availability of at least one 7-8\u002F8 (9-10\u002F10) HLA-matched related (excluding an identical twin) or unrelated donor, or an HLA-haploidentical related donor\n* Consensus among the PI, key AIs, and consultants (as necessary) that correction of the patient s immune system through BMT has the potential to improve the patient s health, quality of life, and\u002For life expectancy, after taking into consideration the patient s existing non-hematopoietic, potentially irreversible organ dysfunction\n* Adequate end-organ function, as measured by:\n\n  * Left ventricular ejection fraction (LVEF) \\>= 40% by 2D echocardiogram (ECHO) or MUGA, or left ventricular shortening fraction \\>= 20% by ECHO for patients receiving RIC or RIC-MMF, or RIC-SHORT, or LVEF \\>= 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis.\n  * Pulmonary function tests: DL(co) (corrected for hemoglobin) and FEV(1) \\>= 40% of predicted for the RIC, RIC-MMF, and RIC-SHORT arms; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92% on room air. Calculations will be based on the values reported in CRIS.\n  * Bilirubin \\\u003C= 3.0 mg\u002FdL (unless due to Gilbert s syndrome or hemolysis) for patients receiving RIC, RIC-MMF, RIC-SHORT; ALT and AST 10 x ULN for patients receiving RIC, RIC-MMF, RIC-SHORT. Patients who are above these bilirubin, ALT, or AST thresholds may be eligible for the RIC, RIC-MMF, or RIC-SHORT arms if evaluated by a hepatologist who deems the liver function test abnormalities to be potentially reversible with bone marrow transplant.\n  * Estimated creatinine clearance of \\>= 40 mL\u002Fmin\u002F1.73 m\\^2, calculated using the Cockcroft-Gault equation for adults and Schwartz formula for pediatric patients, for patients with creatinine levels above the institutional upper limit of normal\n* Karnofsky or Lansky performance status of \\>=60% or ECOG performance status of 2 or less\n* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document\n* Not pregnant or breastfeeding. As therapeutic agents used in this trial may be harmful to a fetus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-allo BMT. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately.\n* Disease status: Patients with malignancy are to be referred in remission for evaluation, except in cases of virus-associated malignancy who may be referred at any time. Should a patient have progressive disease or a donor becomes unavailable after enrollment, the patient will be referred back to his\u002Fher primary hematologist-oncologist for treatment. If this course of action is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease under the current study, although this should only occur as a bridge to transplant. If under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he\u002Fshe must come off the study. Patients receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol.\n\nEXCLUSION CRITERIA - RECIPIENT:\n\n* Patients who are receiving any other investigational agents, with the exception of virus-specific cytotoxic T-cells for the treatment of viral infection\u002Freactivation prior to allo BMT.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents (cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or filgrastim biosimilar) used in the study\n* Active psychiatric disorder which may compromise compliance with the transplant protocol, or which does not allow for appropriate informed consent\n* Active central nervous system (CNS) involvement by malignancy, except in cases of virus-associated malignancies with CNS involvement in which case the patient may benefit from the transplant to control the malignancy.\n* MAGT1 mutation and active need to take anti-platelet agents and\u002For therapeutic anti-coagulation that cannot be interrupted during aplasia.\n* HIV positive or other acquired immunodeficiency that, as determined by the PI, interferes with the assessment of PID severity and\u002For the attribution of clinical manifestations of immunodeficiency to a PID.\n* Lack of adequate central venous access potential\n\nInclusion Criteria (Related Donor):\n\n* Ages \\>= 4\n* Related donor deemed suitable and eligible and willing to donate per clinical evalations who are additionally willing to donate blood, urine, and marrow specimens for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation. Note that participation in this study is offered to all related donors but is not required for clinical donation, so it is possible that not all related donors will enroll on this study.\n\nExclusion Criteria (Related Donor):\n\nNone\n\nINCLUSION CRITERIA - UNRELATED DONOR:\n\n* Ages \\>= 18\n* Unrelated donors will be evaluated in accordance with existing NMDP Standard Policies and Procedures, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobal-transplant-network\u002FStandards\u002F, except for the additional requirement of EBV serostatus testing. Note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study.\n\nEXCLUSION CRITERIA - UNRELATED DONOR:\n\n-Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP Standards, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobal-transplant-network\u002FStandards\u002F.","4 Years","75 Years",{"count":58,"type":22},354,[25],"Background:\n\nAllogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems.\n\nObjective:\n\nTo see if allogeneic blood or bone marrow transplant is safe and effective in treating people with primary immunodeficiencies.\n\nEligibility:\n\nDonors: Healthy people ages 4 or older\n\nRecipients: People ages 4-75 with a primary immunodeficiency that may be treated with allogeneic blood or marrow transplant\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, and blood tests.\n\nParticipants will have urine tests, EKG, and chest x-ray.\n\nDonors will have:\n\nBone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone.\n\nOR\n\nBlood collection: They will have several drug injections over 5-7 days. Blood is taken by IV in one arm, circulates through a machine to remove stem cells, and returned by IV in the other arm.\n\nPossible vein assessment or pre-anesthesia evaluation\n\nRecipients will have:\n\nLung test, heart tests, radiology scans, CT scans, and dental exam\n\nPossible tissue biopsies or lumbar puncture\n\nBone marrow and a small piece of bone removed by needle in the hipbone.\n\nChemotherapy 1-2 weeks before transplant day\n\nDonor stem cell donation through a catheter put into a vein in the chest or neck\n\nSeveral-week hospital stay. They will take medications and may need blood transfusions and additional procedures.\n\nAfter discharge, recipients will:\n\nRemain near the clinic for about 3 months. They will have weekly visits and may require hospital readmission.\n\nHave multiple follow-up visits to the clinic in the first 6 months, and less frequently for at least 5 years.",[62,63,30,64,29],"Primary T-cell Immunodeficiency Disorders","Common Variable Immunodeficiency","Autoimmune Lymphoproliferative",[66,32,33,34,35],"Haploidentical","2026-06-27",{"date":69,"type":40},"2026-06-30",{"date":71,"type":40},"2015-11-19",{"date":73,"type":22},"2036-12-31",{"name":46,"class":47},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100316038","phase-3-a-phase-3-study-of-tabelecleucel-for-participants-with-epstein-barr-virus-associated-post-transplant-lymphoproliferative-disease-after-failure-with-rituximab-or-rituximab-and-chemotherapy-100316038","NCT03394365","A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy","Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy","ALLELE","Inclusion Criteria:\n\n1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).\n2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD.\n3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.\n4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and\u002For brain\u002Fspinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.\n5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.\n6. Males and females of any age.\n7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants \\\u003C 16 years.\n8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission.\n9. Adequate organ function.\n\n   1. Absolute neutrophil count ≥ 1000\u002FμL, (C-SOT) or ≥ 500\u002FμL (C-HCT), with or without cytokine support.\n   2. Platelet count ≥ 50,000\u002FμL, with or without transfusion or cytokine support. For C-HCT, platelet count \\\u003C 50,000\u002FμL but ≥ 20,000\u002FμL, with or without transfusion support, is permissible if the participant has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \\[CTCAE\\], version 5.0).\n   3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \\\u003C 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and\u002For PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction.\n10. Participant or participant's representative is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Currently active Burkitt, T-cell, NK\u002FT-cell lymphoma\u002FLPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.\n2. Daily steroids of \\> 0.5 mg\u002Fkg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.\n3. Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.\n4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.\n5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.\n6. For C-HCT: active adenovirus viremia.\n7. Need for vasopressor or ventilatory support.\n8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment.\n9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only).\n10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.\n11. Inability to comply with study-related procedures.\n12. Any medical condition or organ system dysfunction that in the investigator';s opinion, could compromise the participant's safety or ability to complete the study.",{"count":84,"type":22},115,[86],"PHASE3","The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.",[89,90,29,91,92],"Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)","Solid Organ Transplant Complications","Allogeneic Hematopoietic Cell Transplant","Stem Cell Transplant Complications",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,91,111],"Epstein-Barr Virus (EBV)-associated Lymphoproliferative Disease (LPD)","Epstein-Barr Virus (EBV)","Cytotoxic T lymphocyte (CTL)","Cancer After Transplant","Kidney transplant","Renal transplant","Liver transplant","Heart transplant","Lung transplant","Intestinal transplant","Pancreas transplant","Post-transplant Lymphoma","Solid Organ Transplant (SOT)","Bone Marrow Transplant Complications","Epstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)","Hematopoietic Cell Transplant (HCT)","Hematopoietic Stem Cell Transplantation (HSCT)","Allogeneic, Off-The-Shelf T-cell Immunotherapy","2026-05-20",{"date":114,"type":40},"2026-05-22",{"date":116,"type":40},"2017-12-29",{"date":118,"type":22},"2030-08",{"name":120,"class":121},"Pierre Fabre Medicament","INDUSTRY",71,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100388586","phase-2-allogeneic-hematopoietic-stem-cell-transplant-for-patients-with-inborn-errors-of-immunity-100388586","NCT04339777","Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity","A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity","* INCLUSION CRITERIAl:\n* Age \\>= 4 years and \\\u003C=69 yo with Weight \\>=12 kilograms\n* Mutation in a known monogenic (IEI) gene performed by a CLIA certified laboratory, who have failed standard medical management, or when no standard medical management is available.\n\nOR\n\nPatients without a known IEI mutation may be eligible if they have a clinical history that is characteristic of an individual with an immune defect including a history of infections requiring prolonged courses of therapy or evidence of immune dysregulation manifested by autoimmune\u002Fautoinflammatory disease, atopy, hemophagocytic lymphohistiocytosis, hypogammaglobulinemia, or impaired response to vaccination. A virally-driven malignancy alone will also constitute basis for inclusion.\n\n* Availability of an 8\u002F8, 7\u002F8, or 6\u002F8 HLA-matched related or unrelated donor (if the mismatch is at DQ this will be considered an 8\u002F8 matched donor), or a haploidentical related donor. Karnofsky or Lansky performance status of \\>= 40%\n* Adequate end-organ function, as measured by:\n\n  --Left ventricular ejection fraction \\> 40%, preferably by 2-D echocardiogram (ECHO) obtained within 60 days prior to enrollment.\n* Creatinine: Adult patients: \\\u003C= 2.0 mg\u002Fdl and creatinine clearance \\>= 30 ml\u002Fmin; Pediatric patients (\\\u003C18 years old): creatinine \\\u003C 1.5 mg\u002FdL and a creatinine clearance, using the Schwartz Formula \\> 30 mL\u002Fmin\u002F1.73m\\^2.\n\n  * Serum conjugated bilirubin \\\u003C 2.5 mg\u002Fdl; serum ALT and AST \\\u003C= 5 times upper\n\nlimit of normal.\n\n--Pulmonary function tests: FEV1 \\> 30% and DLCO \\>30%. Children who are unable to have DLCO assessed due to age, are still eligible if no evidence of dyspnea at rest and no need for supplemental oxygen.\n\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document. For subjects \\\u003C18 years old, their legal guardian must give informed consent. Pediatric patients will provide assent.\n* As therapeutic agents used in this trial may be harmful to a fetus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-allo HCT. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately.\n* Willingness to remain in the NIH hospital or, if discharged, stay close to the NIH, for a minimum of 100 days after transplant or longer, if there are complications. If outpatient in the first 100 days after transplant, patient must commit to having an adult caregiver with them at all times.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents (with the exception of virus-specific therapy e.g. cytotoxic T-cells for the treatment of viral infection\u002Freactivation prior to allo HCT).\n* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents (steroids, cyclophosphamide, busulfan, tacrolimus, sirolimus, MMF, G-CSF, alemtuzumab) used in the study\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol or which does not allow for appropriate informed consent\n* Pregnant women are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with the study agents.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","69 Years",{"count":132,"type":22},66,[25],"Background:\n\nDuring a transplant, blood stem cells from one person are given to someone else. The cells grow into the different cells that make up the immune system. This can cure people with certain immunodeficiencies. But transplant has many risks and complications.\n\nObjective:\n\nTo see if stem cell transplant can be successfully performed in people with primary immunodeficiency disease and cure them.\n\nEligibility:\n\nPeople ages 4-69 for whom a primary immunodeficiency (PID) or Primary Immune Regulatory Disorder (PIRD), has caused significant health problems and either standard management has not worked or there are no standard management options, along with their donors\n\nDesign:\n\nDonors will be screened under protocol 01-C-0129. They will donate blood or bone marrow.\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood, urine, and heart tests\n\nCT or PET scans\n\nBefore transplant, participants will have dental and eye exams. They will have a bone marrow biopsy. For this, a needle will be inserted through the skin into the pelvis to remove marrow.\n\nParticipants will be hospitalized before their transplant. They will have a central catheter put into a vein in their chest or neck. They will get medications through the catheter to prevent complications. Participants will get stem cells through the catheter. They will stay in the hospital for at least 4 weeks. They will give blood, urine, bone marrow, and stool samples. They may need blood transfusions. They may need more scans. They will take more medications.\n\nParticipants will have visits on days 30, 60, 100, 180, and 360, and 24 months after the transplant. Then they will have visits once a year for about 5 years",[29,64,30,63,62],[32,66,35,33,34],"2026-05-01",{"date":139,"type":40},"2026-05-04",{"date":141,"type":40},"2020-09-22",{"date":143,"type":22},"2027-11-30",{"name":46,"class":47},1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":159,"conditions":160,"keywords":174,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100598722","phase-1-a-study-to-evaluate-a-novel-gene-therapy-in-patients-with-relapsed-and-refractory-multiple-myeloma-100598722","NCT07075185","A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma","inMMyCAR","Inclusion Criteria:\n\n* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease\n* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody\n* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1\n* Participants must have acceptable laboratory values as defined by the protocol\n\nExclusion Criteria:\n\n* Participants must not have known central nervous system (CNS) involvement with myeloma\n* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis\n* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy\n* Participants cannot require systemic steroids for any condition","18 Years",{"count":156,"type":22},70,[158],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.",[161,162,163,164,165,166,167,168,169,170,29,171,172,173],"Multiple Myeloma in Relapse","Myeloma Multiple","Multiple Myeloma Progression","Neoplasms by Histologic Type","Neoplasm","Hemostatic Disorders","Vascular Disorder","Paraproteinemias","Blood Protein Disorders","Hematologic Disease and Disorders","Immunoproliferative Disorders","Immune System Disease","Gene Therapy",[175,176,177,178],"in vivo CAR-T","multiple myeloma","gene therapy","BMCA","2026-04-22",{"date":181,"type":40},"2026-04-24",{"date":183,"type":40},"2025-07-16",{"date":185,"type":22},"2042-05",{"name":187,"class":121},"Kelonia Therapeutics, Inc.",7,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":145},"100067525","establishing-a-tumor-bank-in-families-with-multiple-lymphoproliferative-malignancies-100067525","NCT00131014","Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies","Establishing a Tumor Bank and Initial Analysis of Germline and Tumor-Related Genetic Alterations in Families With Multiple Lymphoproliferative Malignancies","Inclusion Criteria:\n\n* Any individual diagnosed with non-Hodgkin's lymphoma or Hodgkin's disease or chronic lymphocytic leukemia (CLL), who has a 1st degree relative (parent, sibling or child) with a lymphoproliferative disorder; or families in which the individual has a lymphoproliferative disorder, and an unusual clustering of frequent or premature solid tumors is also observed.\n* Family members of the individual, either affected or unaffected with lymphoma, who are contacted by the individual and agree to participate in the study.\n* Deceased family members may be included in the study. Public records such as death certificates may be used to confirm the history. Consent for medical records or tissue blocks will be obtained from the deceased family member's next of kin. The hierarchy of relatives defined as next of kin is spouse, offspring, parents and siblings. Archived tissue samples may be used for genetic research.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Subjects without a family history of lymphoma",{"count":197,"type":22},1500,"OBSERVATIONAL","The purpose of this study is to investigate possible genetic factors that contribute to the development of lymphomas. The databank will be used to determine whether familial lymphomas have unique genetic characteristics different from sporadic lymphomas and to attempt to identify a gene that confers an increased risk of lymphoma.",[201,202,203,29],"Non-Hodgkin's Lymphoma","Hodgkin's Disease","Leukemia, Lymphocytic, Chronic",[201,205,206,207,208],"Hodgkin's disease","Chronic Lymphocytic Leukemia","Lymphoproliferative disorder","Genetics","2026-04-21",{"date":181,"type":40},{"date":212,"type":40},"2004-08-09",{"date":214,"type":22},"2033-01",{"name":216,"class":217},"Dana-Farber Cancer Institute","OTHER",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":226,"targetDuration":228,"studyType":198,"phases":4,"briefSummary":229,"conditions":230,"keywords":245,"overallStatus":247,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":145},"100513772","clonal-hematopoiesis-of-immunological-significance-100513772","NCT05969821","Clonal Hematopoiesis of Immunological Significance","Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study","CHIS","Inclusion Criteria:\n\n* Age \\>=18 years old;\n* Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease;\n* Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification\n\nExclusion Criteria:\n\n* Persons benefiting from special protection: adults under guardianship and curatorship;\n* People hospitalized without their consent and not protected by law; persons deprived of liberty;\n* Persons not affiliated to the social security system",{"count":227,"type":22},5000,"10 Years","Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.",[30,231,232,233,234,235,236,237,238,239,240,241,29,242,243,244],"Autoimmune Diseases","Inflammation","Autoinflammatory Diseases","Vexas Syndrome","Hematopoiesis Clonal","Clonal Hematopoiesis of Indeterminate Potential","Hematologic Diseases","Myelodysplastic-Myeloproliferative Diseases","Leukemia Myelomonocytic Chronic","Myelodysplastic Syndromes","Myeloproliferative Disorders","Lymphoma","Leukemia","Monoclonal Gammopathy of Undetermined Significance",[232,233,246,231,236,238,29,244],"Vexas syndrome","NOT_YET_RECRUITING","2026-03-19",{"date":250,"type":40},"2026-03-23",{"date":252,"type":22},"2026-04",{"date":254,"type":22},"2045-09",{"name":256,"class":217},"Assistance Publique - Hôpitaux de Paris",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":145},"100627234","chemogenomic-profiling-in-hematological-malignancies-hem-profiling-2021-100627234","NCT07445984","Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)","Inclusion Criteria:\n\n* Patient aged \\>1 year old, referred for evaluation to the University Hospital of Parma;\n* Retrospective study: previously patients with hematological malignancies;\n* Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate\u002Fbiopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed\u002Frefractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate\u002Fbiopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed\u002Frefractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate\u002Fbiopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc;\n* Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit.\n\nExclusion Criteria:\n\n* Age \\\u003C1 year old\n* Patients who are unable to provide informed consent prior to any procedure for any reason.","1 Year",{"count":265,"type":22},250,[267],"NA","The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.",[270,271,241,29,272],"Chronic Leukemia","Acute Leukemia","Myelodysplastic Disorders","2026-02-25",{"date":275,"type":40},"2026-03-03",{"date":277,"type":40},"2021-07-28",{"date":279,"type":22},"2026-07-28",{"name":281,"class":217},"Azienda Ospedaliero-Universitaria di Parma",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":145},"100627192","feasibility-of-a-multi-omics-platform-for-hematological-malignancies-100627192","NCT07445438","Feasibility of a Multi-omics Platform for Hematological Malignancies","FOCUS","Inclusion Criteria:\n\n* Patient aged \\> 2 year old\n* Retrospective study:\n* Patients previously diagnosed with hematological malignancies\n* Prospective study:\n* Patients with clinical suspect of hematological malignancies requiring a diagnostic assessment using BM or PB samples, biopsies of lymph nodes or tissues with metastatic involvement, or other biological fluids (such as CSF, pathologic pleural effusion).\n* Patients with clinical suspicion of R\u002FR onco-hematological disorder, requiring a diagnostic assessment using BM aspirate\u002Fbiopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from lumbar puncture, tissue aspirate etc.\n* Patients with blastic transformation from a chronic condition or suspect of R\u002FR hematological disease requiring a diagnostic assessment using PB drawn, BM aspirate\u002Fbiopsy, lymph nodes biopsies, or biopsies of tissues with metastatic involvement, including CSF from lumbar puncture, tissue aspirate, etc.\n\nExclusion Criteria:\n\n* Age \\\u003C2 year old\n* Patient without a diagnosis of hematological malignancy.","2 Years",{"count":291,"type":22},1040,[267],"This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement, and other biological fluids, such as cerebrospinal fluid and pathological pleural effusion.",[162,270,271,241,29,272],{"date":275,"type":40},{"date":297,"type":40},"2025-03-31",{"date":299,"type":22},"2030-03",{"name":281,"class":217},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":331,"overallStatus":247,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.",{"count":310,"type":22},30,[25,86],"This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[314,315,29,164,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330],"Haematological Malignancy","Malignant Neoplasm","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour",[332,333,320,334,335,336,337,338,339,340,316,341,342,343,344,345,346,347,348],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-02-23",{"date":351,"type":40},"2026-02-27",{"date":353,"type":22},"2026-02",{"date":355,"type":22},"2029-10",{"name":357,"class":217},"Cancer Research UK",27,{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":145},"100508313","virtual-rehabilitation-for-cancer-survivors-100508313","NCT05898789","Virtual Rehabilitation for Cancer Survivors","Pragmatic Hybrid Type 1 Effectiveness-implementation (E-I) Trial of a Virtual Cancer Rehabilitation Program","Inclusion Criteria:\n\n* 1\\) Age 18 years or older\n* 2\\) Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck (stage I-III), or lymphoma\u002Flymphoproliferative disorder (excluded: recurrent, refractory, progressive, received or planning to receive transplant)\n* 3\\) Completed a primary treatment (i.e. surgery and\u002For radiation and\u002For systemic therapy of any kind) within the last 24 months\n* 4\\) If patients received systemic therapy of a fixed duration with adjuvant\u002Fcurative intent, the main part should be completed, but patients are eligible if on primary, maintenance, or other adjuvant systemic therapy (e.g. eligible while on trastuzumab, immunotherapy, rituximab, oral endocrine or targeted therapy - ie ibrutinib). Indolent non-curative lymphoma patients are eligible if they have response to systemic therapy\n* 5\\) Communicate sufficiently in English to complete intervention and questionnaires\n* 6\\) Willing to be randomized and participate in the intervention and attend in-person or virtual assessments\n* 7\\) Internet access\n* 8\\) An indication for cancer rehabilitation (WHO-DAS score \\>5).\n\nExclusion Criteria:\n\n* 1\\) Impaired functional status that would preclude rehabilitation (PRFS \\>3)\n* 2\\) Indication of major depressive disorder (\\> or = to 20 on PHQ-9)\n* 3\\) Diagnosis of neurological disease or condition significantly limiting cognitive functioning, such as language or memory (e.g., Alzheimer's disease or other dementia, severe traumatic brain injury);\n* 4\\) Currently enrolled in another personalized and supervised exercise or rehabilitation program\n* 5\\) Conditions or current injuries which are not appropriate for distance based exercise (based on intake screening questions and as determined by physician\\*. \\*In cases where patient's indicate an existing higher risk condition (i.e high blood pressure, recent heart attach or unstable angina, spinal cord compression, recent deep vein thrombosis) or injury, the study team will contact the physician for medical approval and clearance to participate in the study will be required)",{"count":367,"type":22},388,[267],"Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.",[371,372,373,242,374,375,376,377,378,379,380,29],"Breast Cancer, Stage 0","Colorectal Cancer Stage I","Head and Neck Cancer Stage I","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Head and Neck Cancer Stage II","Head and Neck Cancer Stage III",{"date":273,"type":40},{"date":383,"type":40},"2023-07-07",{"date":385,"type":22},"2026-11-30",{"name":387,"class":217},"University Health Network, Toronto",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":412},"100428378","phase-2-pacritinib-in-relapsedrefractory-t-cell-lymphoproliferative-neoplasms-100428378","NCT04858256","Pacritinib in Relapsed\u002FRefractory T-cell Lymphoproliferative Neoplasms","Phase 2, Open Label, Multicenter Study of Pacritinib in Relapsed\u002FRefractory T-cell Lymphoproliferative Neoplasms","Selected 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. Subject must have the ability to understand and the willingness to sign a written informed consent.\n2. ECOG performance status ≤ 2\n3. A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or CTCL subtype listed in the protocol.\n4. Relapsed or refractory disease. Refractory disease is defined as progression during treatment or recurrent\u002Fprogressive disease within 6 months of completing a treatment regimen that achieved either stable disease or a PR\u002FCR. Relapsed disease is defined as progression or recurrence at least 6 months after a prior documented response (PR or CR).\n5. Adequate organ and hematopoietic function as defined in the protocol.\n6. Sufficient archival tissue (15 unstained slides obtained within 90 days prior to registration) is required. If available, this tissue should be identified at screening and shipped prior to C2D1.If not available, a lymph node or tissue biopsy (core-needle or excisional) or skin biopsy (for CTCL) is required. The type of tissue obtained is at the discretion of the investigator based on disease. NOTE: If archival tissue is not available and a fresh biopsy is inaccessible or technically challenging (per site investigator discretion) at the site, the subject may be eligible for the study.\n7. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is based on known history and local policies.\n8. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is based on known history and local policies.\n9. Ability to take oral medication without crushing, dissolving or chewing tablets.\n10. In the investigator's opinion, the patient requires treatment, has an anticipated life expectancy of at least 3 months, and the patient has the ability to communicate satisfactorily with the investigator and the study team, to participate fully in the study, and comply with all requirements.\n\nSelected Exclusion Criteria:\n\n1. History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study\n2. Pregnant or breast feeding women. NOTE: women may not breast feed or store breast milk during treatment and for 3 months after pacritinib discontinuation.\n3. Unwilling or unable to use a medically acceptable form of contraception during the time of participation in the trial (sexual abstinence is permissible) unless documented successful vasectomy, hysterectomy, bilateral oophorectomy or post-menopausal for at least 2 years. Women of childbearing potential must use highly effective methods of birth control from the time of informed consent, for the duration of pacritinib treatment and for 30 days after discontinuation of pacritinib. This timeframe also applies to breast-feeding and egg donation. Fertile males must use contraception from the time of study treatment initiation, for the duration of pacritinib treatment and for 30 days after discontinuation of pacritinib. This timeframe is also applicable to sperm donation. Participants should be informed of the risk of unintended pregnancy due to potential reduced effectiveness of hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin) during treatment with pacritinib.\n4. Uncontrolled current illness, including, but not limited to the following:\n\n   1. Ongoing or active infections requiring intravenous antimicrobials\n   2. Symptomatic congestive heart failure (CHF) defined as NYHA class II, III or IV (Appendix II), or ejection fraction \\\u003C45% in any patient.\n   3. Unstable angina pectoris within 6 months of study enrollment\n   4. Unstable cardiac arrhythmia\n   5. History of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment\n   6. Moderate to severe hepatic impairment (Child-Pugh class B or C).\n   7. Psychiatric illness or social situations that would limit compliance with study requirements.\n5. Recent (within 21 days of initiation of therapy, day 1) major surgery\n6. Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment related toxicity; less than 90 days have passed since date of autologous stem cell transplant and patient has not recovered to ≤grade 1 toxicity related to this procedure.\n7. Use of systemic steroids at a dose equivalent to \\>10 mg\u002Fday of prednisone\n8. Prior treatment with pacritinib\n9. Requires use of a medication that increases the risk of bleeding, including anticoagulation or antiplatelet therapy with the exception of aspirin at doses of ≤ 100mg daily.\n10. History of significant bleeding (≥ Grade 2 by CTCAE), bleeding diatheses, or bleeding complications within the past 3 months.\n11. Hypersensitivity or allergic reaction to compounds related to pacritinib.\n12. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors (See Appendix III), for which no alternative is available. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors requires a washout period of 2 weeks prior to initiation of therapy, Cycle 1 Day 1.\n13. Uncontrolled diarrhea. NOTE: patients with chronic diarrhea that is well controlled with supportive care measure (e.g. anti-motility agents) are eligible\n14. Any gastrointestinal or metabolic condition that in the opinion of the investigator could interfere with the absorption of an oral medication.\n15. Prior allogeneic stem-cell transplant.",{"count":396,"type":22},100,[25],"The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.",[400,29],"T-Cell Neoplasm",[402],"pacritinib","2026-01-28",{"date":405,"type":40},"2026-01-29",{"date":407,"type":40},"2023-03-29",{"date":409,"type":22},"2028-11",{"name":411,"class":217},"University of Michigan Rogel Cancer Center",6,{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":307,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":427,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":358},"100498421","phase-2-determine-trial-treatment-arm-01-alectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-alk-positive-cancers-100498421","NCT05770037","DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB) OUTLINED BELOW\\*\n\n\\*When alectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method.\n\nB. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of highly effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion B, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. Paediatric patients (patients aged \\\u003C18 years) must have a body weight ≥40kg.\n\nF. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion Criteria:\n\nA. Diagnosis of ALK-positive non-small cell lung cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib.\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori\\^\\[®\\]) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.\n\nD. History of or radiological evidence of interstitial lung disease and\u002For pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for \\>6 months.\n\nE. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of GI perforation (unless patient has also been co-prescribed gastric protection).\n\n• Patients who present with a GI primary tumour or metastases to the GI tract may be considered.\n\nF. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength).\n\nG. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]), or cardiovascular event (including acute myocardial infarction \\[MI\\]), within three months before the first dose of alectinib.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of alectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. History of organ transplantation.\n\nI. Symptomatic bradycardia for age.\n\nJ. Known hypersensitivity to alectinib or any of the excipients. See the current alectinib (Alecensa® 150 mg hard capsules) SmPC for the full list.\n\nK. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during alectinib treatment or within six months after the final dose of alectinib.\n\nL. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS) related illness. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002FAIDS-associated opportunistic infection in the last 12 months.\n\nM. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient.\n\nN. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.",{"count":310,"type":22},[25,86],"This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[314,315,29,164,316,320,424,242,425,426,330],"Anaplastic Large Cell Lymphoma","Renal Cell Carcinoma","Neuroblastoma",[332,428,429,333,320,334,336,337,338,339,340,316,341,342,344,345,430,348],"Alectinib","ALK Tyrosine Kinase Receptor","Tumour-agnostic","2025-11-19",{"date":433,"type":40},"2025-11-24",{"date":435,"type":40},"2023-12-18",{"date":355,"type":22},{"name":357,"class":217},{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":307,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":358},"100498460","phase-2-determine-trial-treatment-arm-03-entrectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-ros1-gene-fusion-positive-cancers-100498460","NCT05770544","DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\\*\n\n\\*When entrectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.\n\nB. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nC. Patients with a BSA of 0.43m\\^2 and over.\n\nD. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and either:\n* Agree to use one form of highly effective birth control method such as:\n\nI. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\nII. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation\n\nIII. Intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. Bilateral tubal occlusion\n\nVI. Vasectomised partner\n\nPlus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR\n\n• Sexual abstinence;\n\nEffective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.\n\nG. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib\n\nB. Diagnosis of ROS1 fusion-positive NSCLC\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib\n\nD. Patients with significant cardiovascular disease are excluded as defined by:\n\ni. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \\\u003C50% (moderate to severe).\n\nii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).\n\niii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association\u002FAmerican Cardiac College Stage C or D).\n\niv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.\n\nv. History of stroke (ischaemic or haemorrhagic) within the last three months.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nE. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.\n\nF. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)\n\nG. Grade ≥2 peripheral neuropathy\n\nH. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.\n\nI. Known hypersensitivity to entrectinib or any of the excipients\n\nJ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib\n\nK. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption\n\nL. Patients with personal history of significant osteopenia (screening for osteopenia not required)\n\nM. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial",{"count":310,"type":22},[25,86],"This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[314,336,315,29,164,316,320,449,450,327,330],"Brain Neoplasms","Melanoma",[332,333,320,334,452,336,337,338,339,340,316,453,341,344,345,454,430,348],"Entrectinib","Oncogene","ROS1 Protein, human",{"date":433,"type":40},{"date":457,"type":22},"2025-11-30",{"date":355,"type":22},{"name":357,"class":217},{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":307,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":358},"100498426","phase-2-determine-trial-treatment-arm-02-atezolizumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-high-tumour-mutational-burden-tmb-or-microsatellite-instability-high-msi-high-or-proven-constitutional-mismatch-repair-deficiency-cmmrd-disposition-100498426","NCT05770102","DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\\*\n\n\\*When atezolizumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut\u002FMb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut\u002FMb may be discussed in an MTB meeting. TMB ≥19 mut\u002FMb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Women of childbearing potential are eligible provide they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (\\[oral, intravaginal or transdermal\\]);\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);\n\nIII. intrauterine device (IUD),\n\nIV. intrauterine hormone-releasing system (IUS),\n\nV. bilateral tubal occlusion,\n\nVI. vasectomised partner,\n\nVII. sexual abstinence,\n\nVIII. male or female condom with or without spermicide;\n\nIX. cap, diaphragm or sponge with spermicide.\n\nEffective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.\n\nExclusion Criteria:\n\nA. Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.\n\nB. Patients with rapidly progressing or symptomatically deteriorating brain metastases and\u002For leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and\u002For stereotactic radiosurgery at least 14 days prior to the start of IMP administration.\n\n• Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.\n\nD. History or clinical evidence of current inflammatory lung disease:\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nE. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.\n\nF. Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).\n\nG. Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:\n\n* Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.\n* Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.\n* Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.\n* Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.\n\nH. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n\nI. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.\n\nJ. Known hypersensitivity to Chinese hamster ovary cell products.\n\nK. Known hypersensitivity to atezolizumab or any of the excipients.\n\nL. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.\n\nM. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attacks \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of atezolizumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nPatients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.\n\nN. Prior allogeneic stem cell or solid organ transplantation on immunosuppression.\n\nO. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.\n\nP. Uncontrolled diabetes.\n\nQ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nR. Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.",{"count":310,"type":22},[25,86],"This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nAtezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB\u002FMSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[336,315,29,164,316,320,324,471,450,472],"Endometrial Neoplasms","Solid Tumours",[332,333,474,320,334,336,337,338,164,316,341,342,345,430,348],"Atezolizumab",{"date":433,"type":40},{"date":477,"type":40},"2023-10-25",{"date":355,"type":22},{"name":357,"class":217},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":56,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":497,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":145},"100536932","phase-1-a-study-to-evaluate-the-safety-pkpd-of-oricar-017-in-subjects-with-rrmm---rigel-study-100536932","NCT06271252","A Study to Evaluate the Safety, PK\u002FPD of (OriCAR-017) in Subjects With RR\u002FMM - RIGEL Study","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\nCapable of giving signed informed consent\n\nSubjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).\n\nExpected survival period is \\>12 weeks.\n\nDiagnosis of MM according to the IMWG criteria (2016 version).\n\nOne of the following criteria must be met:\n\nIf immunoglobulin (Ig)G type MM, then serum M protein \\>10 g\u002FL; if IgA, IgD, IgE or IgM type MM, then serum M protein \\>5 g\u002FL\n\nUrine M protein level \\>200 mg\u002F24 hour\n\nIf light chain type MM, then serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal.\n\nExtramedullary lesions (\\>1 cm for diameter of the short axis).\n\nFor Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.\n\nFor Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)\n\nSubjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.\n\nSubject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.\n\nExclusion Criteria:\n\nPregnant or breastfeeding.\n\nSeropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection\n\nKnown active or prior history of CNS involvement\n\nHistory of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years\n\nPresence of uncontrolled active infection\n\nSubjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.\n\nSubjects who received allogeneic stem cell therapy.\n\nAny condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.\n\nReceived Bendamustine treatment 1 year prior to Screening Visit.",{"count":488,"type":22},81,[158],"The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed\u002Frefractory multiple myeloma.\n\nRIGEL Study",[492,164,493,166,494,495,168,169,237,496,29,171,30,328],"Neoplasms, Plasma Cell","Neoplasms","Vascular Diseases","Cardiovascular Diseases","Hemorrhagic Disorders",[498],"R\u002FR MM, CAR-T","2024-08-01",{"date":501,"type":40},"2024-08-02",{"date":503,"type":40},"2024-04-03",{"date":505,"type":22},"2028-04-12",{"name":507,"class":121},"OriCell Therapeutics Co., Ltd.",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":16,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":516,"targetDuration":518,"studyType":198,"phases":4,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":247,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":4},"100494500","familial-b-cell-lymphoproliferative-disorders-100494500","NCT05718986","Familial B-cell Lymphoproliferative Disorders","Epidemiology of Familial B-cell Lymphoproliferative Disorders","Familial_LPD","Inclusion Criteria:\n\n* Patient inclusion criteria:\n\nPatients must have LPD and must have a family history of LPD. LPD patients who signed an informed consent to participate in the study.\n\nCriteria for the inclusion of relatives of patients:\n\nRelatives must be related by blood to LPD patients or unrelated (for control group).\n\nRelatives who signed an informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women, special populations and those lacking judgment will not be included",{"count":517,"type":22},1000,"15 Years","This study investigates families with at least two cases of B-cell lymphoproliferative disorders (LPD), and evaluates the prevalence of LPD in families, the relationship between medical history, genetic factors, and the risk of familial LPD, and various clinical outcomes for these families in a multiethnic population of Jews and Arabs in Israel.",[29,521,522,206],"Premalignant","Monoclonal B-Cell Lymphocytosis",[524,206,525],"lymphoproliferative disorders","Monoclonal B-cell Lymphocytosis","2024-05-07",{"date":528,"type":40},"2024-05-08",{"date":530,"type":22},"2024-06",{"date":532,"type":22},"2040-12",{"name":534,"class":217},"University of Haifa"]