[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematologic-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematologic-malignancies":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,50,80,117,142,164,190,213,242,266,288,325,349,386,410,446,468,490,514,534,556,581,606,635,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100494895","observational-study-of-cardiac-arrhythmias-during-treatment-with-btk-inhibitors-or-venetoclax-100494895",false,"NCT05724121","Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently receiving or planning to receive a BTKi or venetoclax.\n2. Male or female, aged 18 or older\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Ability of subject to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months\n2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.","ALL","18 Years","110 Years",{"count":20,"type":21},135,"ESTIMATED","OBSERVATIONAL","Background:\n\nBruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart.\n\nObjective:\n\nTo identify and monitor the effects of BTKi on the heart.\n\nEligibility:\n\nPeople aged 18 and older currently receiving or planning to receive BTKi or venetoclax.\n\nDesign:\n\nParticipants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit.\n\nParticipants will undergo multiple tests:\n\nA physical exam, including collection of blood and saliva.\n\nA test that measures heart activity via stickers placed on the chest.\n\nA test that uses sound waves to capture images of the heart.\n\nAn exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises.\n\nStress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken.\n\nParticipants may wear a device to monitor their heart at home.\n\nParticipants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.",[25,26,27,28,29,30],"Chronic Lymphocytic Leukemia (CLL)","Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia","Mantle Cell Lymphoma","Sudden Cardiac Death","Cardiac Arrhythmias","Hematologic Malignancies",[32,25,33,34,35,36],"SUDDEN CARDIAC DEATH","Ibrutinib Treatment","Atrial Fibrillation\u002FFlutter","Ventricular Arrhythmias","Natural History","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2023-03-01",{"date":45,"type":21},"2027-04-08",{"name":47,"class":48},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100475404","phase-1-trial-of-allogeneic-reduced-intensity-hla-haploidentical-allogeneic-hematopoietic-cell-bone-marrow-transplantation-followed-by-graft-versus-host-disease-gvhd-prophylaxis-with-cyclophosphamide-bortezomib-and-maraviroc-for-hematologic-malignancies--100475404","NCT05470491","Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...","A Phase I\u002FII Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)","* INCLUSION CRITERIA - RECIPIENT:\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:\n\n  * Acute myeloid leukemia in morphologic complete remission (\\\u003C5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * Any secondary and\u002For treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy\u002Fradiation\n  * B-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * T-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the Dynamic IPSS-Plus (DIPSS-Plus) or high to very high risk score (5 or higher) calculated with MIPSS70+ Calculator; DIPSS-Plus For Myeloproliferative Neoplasms on the Mutation Enhanced International Prognostic Score System (MIPSS70\u002FMIPSS70+)\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed\u002Fprogressed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy\n  * Burkitt or lymphoblastic lymphoma: high-risk disease in first remission, progression\u002Frelapse after \\>=1 previous regimen\n  * Chronic lymphocytic leukemia with 17p deletion and\u002For unmutated IgHv or refractory or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on published clinical practice guidelines\n  * T-Prolymphocytic leukemia progressing\u002Frelapsing after alemtuzumab and at least one other regimen\n  * B-Prolymphocytic leukemia progressing\u002Frelapsing after fludarabine and at least one other salvage regimen\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma that relapses after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD), relapses after autologous transplantation, or manifests as plasma cell leukemia\n\nIn addition to standard indications for HCT: Participant with a hematologic malignancy eligible for consolidation of first remission with autologous transplantation, if autologous transplantation is not accessible to the participant.\n\n* HIV seropositive, with ART regimen that, when stable for \\>4 weeks, is associated with an HIV viral load \\\u003C400 copies\u002FmL at screening evaluations. Subsequent changes to avoid\u002Foptimize drug interactions with study drugs or essential supportive care drugs may be made to the ART regimen at any time during the eligibility assessment period, as long as the eligibility criteria were met and the regimen change is expected, by the study team and involved consultants\u002Fpharmacy, to be similarly effective for HIV control. These changes to the ART regimen are not part of the study. If changes to the ART regimen are made during the eligibility period, HIV viral load will be rechecked at least 1 week after the change but prior to protocol treatment consent.\n\n  * Dose level 1: ART regimen must include maraviroc\n  * Dose level 2 and 3: ART regimen must not include maraviroc and there must be no history of maraviroc intolerance or resistance\n* Age \\>= 18 years\n* At least one potentially suitable HLA-haploidentical first degree or collateral related donor. Recipients with donor-specific anti-HLA antibodies (DSAs) to all potential donors must have at least one potential donor option where the DSA strength has a mean fluorescence intensity of \\\u003C 5000 and antibodies are not complement-fixing.\n* Karnofsky performance score \\>=50 percent.\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction by 2D ECHO of \\>=40 percent\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLco, adjusted for hemoglobin) all of \\>=40 percent predicted. 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 percent on room air.\n  * Total bilirubin \\\u003C=3.0 mg\u002FdL (unless due to Gilbert's or hemolysis), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \\\u003C= 5x the upper limit of normal, gamma glutamyl transferase (GGT) \\\u003C= 5x the upper limit of normal\n* Estimated serum creatinine clearance of \\>=50 mL\u002Fmin\u002F1.73m2 calculated using eGFR in the clinical lab\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Individuals of childbearing potential and those that 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* Participants who are receiving any other investigational agents that cannot be discontinued\u002Fcompleted at least 2 weeks prior to the date of beginning conditioning.\n* Poorly controlled malignant indication for transplantation, defined as:\n\n  * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5 percent or active extramedullary disease)\n  * Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and\u002For radiologic assessment\n  * Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \\\u003C= 5 percent plasma cells in the bone marrow.\n* Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation.\n* Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \\\u003C400 copies\u002FmL that is compatible with study drugs\n* Pregnancy\n* For lactating potential participants: unwilling to discontinue lactation prior to the start of study treatment on day -14.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (eATG, steroids, cyclophosphamide, busulfan, pentostatin, maraviroc, bortezomib, plerixafor (dose level 3 only)) used in the study.\n* Lack of central access potential sufficient for transplant\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol and\u002For antiretroviral therapy\n* Grade 3-4 motor or sensory neuropathy per CTCAE version 5.0\n\nINCLUSION CRITERIA - RELATED DONOR:\n\n* Related donor (age \\>=12) deemed suitable and eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood and\u002For PBSC graft aliquotfor research. Related donors will be evaluated in accordance with existing institutional Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n* Ability of participant or parent\u002Flegal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA - RELATED DONOR:\n\n-Failure to qualify per institutional Standard Policies",true,"12 Years","120 Years",{"count":61,"type":21},265,"INTERVENTIONAL",[64,65],"PHASE1","PHASE2","Background:\n\nPeople living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.\n\nObjective:\n\nThis study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.\n\nEligibility:\n\nPeople aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.\n\nDesign:\n\nThe study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.\n\nParticipants will be screened. Their diagnoses, organ function and eligibility will be confirmed.\n\nParticipants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.\n\nParticipants will be in the hospital for 6 weeks or longer.\n\nThey will receive various drugs for 2 weeks to prep their body for the transplant.\n\nThe transplant cells will be administered through the catheter.\n\nParticipants will continue to receive drug treatments after the transplant.\n\nBlood transfusions may also be needed.\n\nParticipants will return 1-2 times per week for follow-up visits for 3 months after discharge.\n\nParticipants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.",[68,30],"HIV",[70,71,72],"Hematopoietic Cell Transplant","HCT","Human Immunodeficiency Virus",{"date":40,"type":41},{"date":75,"type":41},"2023-01-26",{"date":77,"type":21},"2027-07-30",{"name":79,"class":48},"National Cancer Institute (NCI)",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":62,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100608004","phase-1-a-study-to-evaluate-inca036873-in-participants-with-advanced-solid-tumors-and-hematological-malignancies-100608004","NCT07195916","A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\n* Age ≥18 years.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed:\n\n  * Clear cell renal cell carcinoma (ccRCC).\n  * Diffuse large B-cell lymphoma (DLBCL, NOS).\n  * High-grade B-cell lymphoma (HGBCL).\n  * Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).\n  * Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0\u002FB1 blood involvement).\n* Disease progression, relapse, or refractory to prior therapy:\n\n  * ccRCC: ≥1 prior line incl. ICI + TKI.\n  * DLBCL\u002FHGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.\n  * PTCL\u002FCTCL: ≥1 prior systemic therapy.\n* Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL\u002FUSCLC\u002FEORTC (CTCL).\n* Tumor tissue available for central testing.\n\nExclusion Criteria:\n\n* Untreated or progressive CNS disease unless previously treated and stable.\n* Other active invasive malignancy within 2 years (except certain low-risk cancers).\n* Prior CD70-targeting therapy, including CAR T.\n* ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.\n* Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).\n* Primary immunodeficiency or active autoimmune disease requiring immunosuppression.\n* Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.\n* Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":88,"type":21},280,[64],"A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.",[92,30],"Solid Tumors",[94,95,96,97,98,99,100,101,102,103,104,105],"Advanced solid tumors","Metastatic solid tumors","Clear cell renal cell carcinoma (ccRCC)","Diffuse large B-cell lymphoma (DLBCL)","High-grade B-cell lymphoma (HGBCL)","Peripheral T-cell lymphoma (PTCL, incl. ALCL)","Cutaneous T-cell lymphoma (CTCL, incl. MF and SS)","Non-Hodgkin lymphoma (NHL)","CD70","Bispecific antibody","Immunotherapy","T-cell engager","2026-06-29",{"date":108,"type":41},"2026-06-30",{"date":110,"type":41},"2026-01-08",{"date":112,"type":21},"2028-08-18",{"name":114,"class":115},"Incyte Corporation","INDUSTRY",22,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":62,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":49},"100605401","phase-1-phase-i-trial-integrating-hla-haploidentical-anti-cd19-car-t-cells-with-post-transplantation-cyclophosphamide-based-hla-haploidentical-hematopoietic-cell-transplantation-100605401","NCT07162038","Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation","Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation","-INCLUSION CRITERIA - Recipient\n\n1. Participants with high or very high-risk hematologic malignancies, as defined by the revised Disease Risk Index (DRI), or malignancy that remains persistently MRD+ (by flow cytometry, cytogenetics, FISH, PCR, or NGS) on most recently assessed disease specimen (within 2 months of initiating conditioning).\n2. Hematologic malignancy must be CD19+ (uniform expression on immunohistochemistry or \\>= 80% on flow cytometry) as confirmed by CD19 IHC assay (BT51E) or flow cytometry (BD QuantiBRITE(TM) Beads PE Fluorescence Quantitation Kit). (Participants do not have to have refused or lack access to commercial anti-CD19 CAR-T-cell therapies since this study focuses on the integration of CAR-T cells and HCT and not specifically the CAR-T cells themselves; furthermore the construct used to manufacture this product is the same as used in a current commercial product, but developed from a new batch and with a similar but not identical manufacturing process.)\n3. Age 18-75\n4. Karnofsky \\>= 60%.\n5. Participants must have adequate organ and marrow function as defined below:\n\n   * Cardiac ejection fraction \\>= 45% by 2D echocardiography;\n   * Forced expiratory volume-1 (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \\>= 50% predicted;\n   * Estimated serum creatinine clearance of \\>= 60 ml\u002Fminute\u002F1.73m\\^2 calculated using eGFR in the clinical lab (participants with estimated serum creatinine clearance less than 60 may have measured creatinine clearance performed and if \\>= 60 will be considered eligible);\n   * Total bilirubin \\\u003C= 2X the upper limit of normal (participants with documented or suspected Gilbert s are exempt from this requirement);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 5X the upper limit of normal.\n6. At least one available HLA-haploidentical donor\n7. Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 1 year after transplant (restriction period).\n\n   Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and for 1 year after transplant. We also will recommend men with female partners of childbearing potential to ask female partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Men must not freeze or donate sperm within the same period.\n8. Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 1 year after transplant.\n9. Participants seropositive for human immunodeficiency virus (HIV) not due to intravenous immunoglobulin, must have been on effective combination anti-retroviral therapy for 6 months and without detectable viral load prior to the beginning of conditioning.\n10. For participants seropositive for hepatitis B virus (HBV) core antibody not due to intravenous immunoglobulin, a HBV viral load should be undetectable.\n11. Participants seropositive for hepatitis C virus (HCV) not due to intravenous immunoglobulin must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n12. Ability of participant to understand and the willingness to sign a written informed consent document.\n13. Ability and willingness of participant to co-enroll on 20-C-0051: Gene Therapy Follow Up Protocol for Subjects Previously Enrolled in NCI for Immuno-Oncology Studies\n\n14 Willingness to remain in the NIH hospital or, if discharged, stay close to the NIH (\\\u003C60 minutes drive), for a minimum of 100 days after transplant or longer if there are complications. Participants must commit to having an adult caregiver with them during the first 100 days after transplant in case of discharging from the hospital before 100 days.\n\nINCLUSION CRITERIA - Donor\n\n1\\. Related donor (age \\>=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool 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 - Recipient\n\n1. Participants who are receiving any other investigational agents within 3 weeks prior to the beginning of conditioning.\n2. Active CNS involvement of primary hematologic malignancy\n3. Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed\u002Frefractory to treatment, or locally advanced and not amenable to intended curative treatment per standard of care.\n4. Prior checkpoint inhibitor therapy within 6 weeks prior to the beginning of conditioning.\n5. Prior history of seizure.\n6. Uncontrolled infection.\n7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in study.\n8. Positive beta-HCG serum or urine pregnancy test performed in females of childbearing potential at screening. (A low positive test in a post-menopausal woman may not be exclusionary if deemed not indicative of pregnancy per gynecology.)\n9. Uncontrolled intercurrent illness evaluated by medical history, physical exam, EKG, and laboratory testing (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance) that would make it unsafe to proceed with transplantation.\n\nEXCLUSION CRITERIA - donor\n\n1\\. Pregnancy","75 Years",{"count":126,"type":21},155,[64],"Background:\n\nHigh-risk blood cancers (leukemias and lymphomas) often come back after treatment, and many cannot be cured with chemotherapy alone. These cancers may be treated and potentially cured in 2 ways: (1) Bone marrow transplant (allogeneic hematopoietic cell transplantation, or alloHCT) gives immune and blood stem cells from a donor. These new cells can attack the cancer and also grow into healthy blood. (2) Chimeric antigen receptor (CAR) T-cell therapy takes immune cells and changes them in a lab to better recognize and target certain cancers. But these 2 treatments are not usually given at the same time.\n\nObjective:\n\nTo test alloHCT and CAR-T cell therapy, used together, in people with high-risk blood cancers.\n\nEligibility:\n\nPeople aged 18 to 75 years with an aggressive blood cancer that has a protein on the surface called CD19. A healthy related donor aged 12 years or older is also needed; this donor may be a parent or child or may be some siblings or even extended family members, but has to be half-matched at something called the HLA (human leukocyte antigen).\n\nDesign:\n\nParticipants will be screened. They will have imaging scans, blood tests, and tests of their heart and lung function. They will have eye and dental exams. They may have fluid drawn from around their spinal cord (spinal tap) and tissue taken from inside a bone (bone marrow biopsy).\n\nHealthy donors will provide bone marrow, immune cells, and about 9 tablespoons of blood for both the recipient s treatment and for research. They will also provide stool, saliva, and oral swabs just for research.\n\nRecipient participants will stay in the hospital for 4 to 6 weeks. They will be given drugs over 6 days to prepare for the cell therapies. Both the donor bone marrow cells and CAR-T-cells will be given through a tube inserted into a vein. They will receive drugs to reduce complications after the treatments.\n\nParticipants will remain within a 1-hour drive of the hospital for 2 to 3 months after they leave the hospital. They will have frequent visits during that time. They will continue to have periodic follow-up visits for 5 years.\n\n...",[30,130],"Hematologic Neoplasms",[132,133,134,70],"Chimeric-Antigen-Receptor T-cell Therapy","High Risk Hematologic Malignancy","CD19","2026-06-26",{"date":106,"type":41},{"date":138,"type":41},"2025-11-14",{"date":140,"type":21},"2034-10-01",{"name":79,"class":48},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":62,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":163},"100512465","phase-2-ivig-for-infection-prevention-after-car-t-cell-therapy-100512465","NCT05952804","IVIG for Infection Prevention After CAR-T-Cell Therapy","Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy","Inclusion Criteria:\n\n* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent\n* For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative must sign an institutional review board (IRB) approved informed consent document prior to the initiation of any screening or study-specific procedures\n* Participants must be 18 years of age or older\n* Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies. Patients receiving an FDA-approved product are eligible even if the product is being administered as part of a clinical trial or expanded access program (e.g., product is 'out of specification'; concomitant anti-tumor treatment such as acalabrutinib)\n* Serum total IgG \\\u003C 600mg\u002FdL within the prior three months\n\n  * Note, if there are additional results ≥ 600 mg\u002FdL within the prior three months, but the patient is receiving IVIG, they remain eligible\n* SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies\n\nExclusion Criteria:\n\n* Primary congenital selective IgA deficiency\n* Prior serious adverse event\u002Fs related to intravenous immune globulin (IVIG) administration\n* Known serious allergy to any component of IVIG\n* Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the investigator, such that it is not in the best interest of the patient to participate in this study\n* SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and\u002For immune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria for grade 3 or higher\n* SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency\n* SUBSEQUENT INFUSIONS: Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the Investigator, such that it is not in the best interest of the patient to participate in this study\n* SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy for which they underwent CARTx\n* SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous) after CARTx\n* SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significant adverse event (AE), severe laboratory abnormality, intercurrent illness, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the participant",{"count":150,"type":21},150,[65],"This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.",[30],"2026-06-25",{"date":106,"type":41},{"date":157,"type":41},"2024-06-10",{"date":159,"type":21},"2028-07-31",{"name":161,"class":162},"Fred Hutchinson Cancer Center","OTHER",7,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":62,"phases":173,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":172,"type":21},3500,[174],"PHASE3","The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[92,30],[178,179,180,181],"PD1","PD-1","PDL1","PD-L1",{"date":135,"type":41},{"date":184,"type":41},"2018-08-21",{"date":186,"type":21},"2043-08-04",{"name":188,"class":115},"Merck Sharp & Dohme LLC",782,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":62,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100579351","phase-1-a-phase-1-study-of-im-1021-in-participants-with-advanced-cancer-100579351","NCT06823167","A Phase 1 Study of IM-1021 in Participants With Advanced Cancer","A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Informed consent signed by the participant prior to conducting study-specific procedures\n2. ≥18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n4. Histological or cytological diagnosis of:\n\n   Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes:\n\n   B-cell Lymphomas:\n   * Mantle cell lymphoma (MCL)\n   * Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)\n   * Follicular lymphoma\n   * Small lymphocytic lymphoma (SLL)\n\n   Solid Tumors:\n   * Pancreatic cancer\n   * Non-squamous non-small cell lung cancer (NSCLC)\n   * Malignant mesothelioma\n   * Epithelial ovarian cancer. Participants with fallopian tube and\u002For peritoneal malignancies are also eligible.\n   * Triple-negative breast cancer.\n   * Liposarcoma\n\n   Other, unlisted histologies, if approved by the Sponsor Medical Monitor\n\n   Part B Cohorts B1, B2, and B3:\n\n   Histological or cytological diagnosis of the cohort-specific disease indication. Indications may include those listed in Inclusion Criterion 4.a\n5. Participants must have adequate organ function.\n6. Participants must have a negative pregnancy test, be willing to practice highly effective methods of birth control, use condoms, and refrain from oocyte\u002Fsperm donation, as applicable, as detailed in the protocol.\n7. Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit. Participants with B-cell malignancies should have received at least two lines of therapy, including available therapies with established benefit. Participants with SLL should have received at least three prior lines of therapy.\n8. Participants must have measurable disease as per the relevant response assessment framework: Lugano Classification for lymphoma (except SLL) , per iwCLL criteria for SLL , and per RECIST v.1.1 for solid tumors.\n\nExclusion Criteria:\n\n1. Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up to one prior ADC with a topoisomerase-1 inhibitor payload.\n2. Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).\n3. History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.\n4. Life expectancy \\\u003C 12 weeks.\n5. Prior solid organ transplant.\n6. Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis or catheter) are eligible.\n7. Participant has a known active central nervous system (CNS) primary tumor or metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg\u002Fday for at least 15 days prior to first dose of study medication. Participants who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) or other clinically appropriate imaging study if the participant is not able to undergo contrast-enhanced MRI and approved by the Sponsor Medical Monitor during the screening period.\n8. Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.\n9. Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.\n10. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.",{"count":198,"type":21},117,[64],"IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.",[202,30],"Solid Malignancies","2026-06-17",{"date":205,"type":41},"2026-06-22",{"date":207,"type":41},"2025-02-26",{"date":209,"type":21},"2029-02",{"name":211,"class":115},"Immunome, Inc.",17,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":222,"studyType":22,"phases":4,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100642137","role-of-viscoelastometric-testing-in-the-development-and-validation-of-a-clinical-biological-score-for-predicting-bleeding-in-patients-with-malignant-haematological-disorders-and-severe-thrombocytopenia-100642137","NCT07653672","Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia","VISCOTHEM-2","Inclusion Criteria:\n\n* Adult patients;\n* Who have been informed about the study and have freely given their informed consent to participate in the study;\n* With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment;\n* With central thrombocytopenia strictly below 20 G\u002FL in a blood sample taken less than 72 hours ago and not having received a transfusion since;\n* Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic;\n* With or without active bleeding;\n* Affiliated with or covered by a social security scheme.\n\nExclusion Criteria:\n\n* Patients who have received at least one of the following treatments:\n* Antiplatelet agents within 7 days prior to enrolment,\n* Vitamin K antagonists within 7 days prior to enrolment,\n* Direct oral anticoagulants within 72 hours prior to enrolment,\n* Low molecular weight heparin within 24 hours prior to inclusion,\n* Unfractionated heparin within 6 hours prior to inclusion,\n* Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion;\n* Patients with a history of thrombopathy;\n* Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis;\n* Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation;\n* Patients already enrolled in the study;\n* Pregnant or breastfeeding women;\n* Patients under guardianship or curatorship;\n* Patients who do not understand French;\n* Patients under judicial protection.",{"count":221,"type":21},410,"5 Days","The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (\\\u003C20 G\u002FL); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding \\\u003C 5%).\n\nThe score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .\n\nParticipants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, urea, creatinin, albumin.",[225,226,227,30],"Thrombocytopenia","Platelet Transfusion","Haemorrhage",[229,230,231,232,233],"viscoelasticity test","thrombocytopenia","haematologic disease","risk of bleeding","clinical and laboratory score","NOT_YET_RECRUITING","2026-06-16",{"date":203,"type":41},{"date":108,"type":21},{"date":239,"type":21},"2028-07-15",{"name":241,"class":162},"Centre Hospitalier Annecy Genevois",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":62,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},"100418452","phase-2-efficacy-and-safety-of-nemtabrutinib-mk-1026-in-participants-with-hematologic-malignancies-mk-1026-003-100418452","NCT04728893","Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)","A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies","Inclusion Criteria:\n\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first dose of study treatment)\n* Has a life expectancy of at least 3 months, based on the investigator assessment\n* Has the ability to swallow and retain oral medication\n* Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization\n* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has adequate organ function\n* Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention\n* Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention\n* Participants with Human immunodeficiency virus (HIV) are eligible if they meet all of the following: the CD4 count is \\>350 cells\u002FuL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART\n\nPart 1 and Part 2 (Cohorts A to C and J)\n\n* Has a confirmed diagnosis of Chronic lymphocytic leukemia\u002F Small lymphocytic lymphoma (CLL\u002FSLL) with\n\n  * At least 2 lines of prior therapy (Part 1 only)\n  * Part 2 Cohort A: CLL\u002FSLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines\n  * Part 2 Cohort B: CLL\u002FSLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive\n  * Part 2 Cohort C: CLL\u002FSLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy\n  * Part 2 Cohort J: CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi, BCL2i and noncovalent\u002Freversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J\n  * Has active disease for CLL\u002FSLL clearly documented to initiate therapy\n  * For SLL participants in Part 2: Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)\n\nPart 2 (Cohorts D to G)\n\n\\- Has a confirmed diagnosis of and meets the following prior therapy requirements:\n\n* Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)\n* Participants with pathologically confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)\n* Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen\n* Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G)\n* Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan\n* Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening\n\nPart 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi\n\n* Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease\n* Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \\>15 mm in the longest diameter or \\>10 mm in the short axis); IgM ≥450 mg\u002FdL; or bone marrow infiltration of 10%\n* Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival\n\nExclusion Criteria:\n\n* Has active HBV\u002FHCV infection (Part 1 and Part 2)\n* Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with SD are not excluded\n* Has active central nervous system (CNS) disease\n* Has an active infection requiring systemic therapy\n* Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* Has any clinically significant gastrointestinal abnormalities that might alter absorption\n* History of severe bleeding disorders",{"count":250,"type":21},490,[65],"The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)\u002F small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).",[30,254,255,256],"Waldenstroms Macroglobulinaemia","Non-Hodgkins Lymphoma","Chronic Lymphocytic Leukaemia","2026-06-10",{"date":259,"type":41},"2026-06-12",{"date":261,"type":41},"2021-04-05",{"date":263,"type":21},"2029-01-04",{"name":188,"class":115},121,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":62,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":49},"100612616","phase-1-a-study-of-bl-m24d1-in-patients-with-relapsed-or-refractory-multiple-myeloma-and-other-hematologic-malignancies-100612616","NCT07255898","A Study of BL-M24D1 in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Gender is not restricted;\n3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Histologically and\u002For cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no standard treatment currently exists;\n6. Must have measurable indicators as defined by the protocol;\n7. Physical condition score ECOG 0 or 1;\n8. Toxicity from previous antitumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n10. Organ function levels must meet the requirements;\n11. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n12. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, the serum pregnancy test must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Subjects with central nervous system involvement, etc.;\n2. Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;\n3. History of severe heart disease;\n4. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Diagnosis of other malignancies within 5 years prior to the first dose;\n7. Hypertension poorly controlled by two antihypertensive medications;\n8. Patients with poorly controlled blood glucose;\n9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n10. Lung diseases defined as ≥ Grade 3 according to CTCAE v5.0; history of interstitial lung disease requiring hormone treatment, etc.;\n11. Patients with peripheral neuropathy ≥ Grade 3 or persistent ≥ Grade 2 peripheral neuropathy with pain;\n12. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;\n13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n14. Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration, etc.;\n16. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first study drug administration;\n18. Participation in another clinical trial within 4 weeks prior to the first dose;\n19. Pregnant or breastfeeding women;\n20. Patients who received live vaccines within 30 days prior to the first dose;\n21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":274,"type":21},33,[64],"This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.",[278,30],"Multiple Myeloma","2026-06-03",{"date":281,"type":41},"2026-06-04",{"date":283,"type":41},"2026-03-25",{"date":285,"type":21},"2027-12",{"name":287,"class":115},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":324},"100159702","a-multicenter-access-and-distribution-protocol-for-unlicensed-cryopreserved-cord-blood-units-cbus-100159702","NCT01351545","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications","Inclusion Criteria:\n\n* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment\n* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment\n* Pediatric and adult patients of any age\n\nExclusion Criteria:\n\n* Patients who are receiving only licensed CBUs\n* Cord blood transplant recipients at international transplant centers\n* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)\n* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated",{"count":296,"type":21},99999,"This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.",[30,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314],"Inherited Disorders of Metabolism","Inherited Abnormalities of Platelets","Histiocytic Disorders","Acute Myelogenous Leukemia (AML or ANLL)","Acute Lymphoblastic Leukemia (ALL)","Other Acute Leukemia","Chronic Myelogenous Leukemia (CML)","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Other Leukemia","Hodgkin Lymphoma","Non-hodgkin Lymphoma","Multiple Myeloma\u002F Plasma Cell Disorder (PCD)","Inherited Abnormalities of Erythrocyte Differentiation or Function","Disorders of the Immune System","Autoimmune Diseases","Severe Aplastic Anemia","2026-06-02",{"date":281,"type":41},{"date":318,"type":4},"2011-10",{"date":320,"type":21},"2041-10",{"name":322,"class":323},"Center for International Blood and Marrow Transplant Research","NETWORK",142,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":62,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":163},"100620610","phase-2-a-study-of-ruxolitinib-for-preventing-graft-versus-host-disease-in-people-with-a-hematologic-malignancy-who-will-receive-a-stem-cell-transplant-100620610","NCT07359859","A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant","Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY","Inclusion Criteria:\n\n* Patients ≥18- years-old at time of consent\n* Diagnosis: hematologic malignancy in morphologic remission (blasts \\\u003C5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response\n* Donor: related or unrelated 7-8\u002F8 HLA-matched or related haploidentical\n* Karnofsky score ≥ 70%\n* Female subjects of childbearing potential (\\\u003C50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.\n\n  °Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: \\*Intrauterine device (IUD) plus one barrier method \\*Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method \\*2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \\* A vasectomized partner.\n* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Recipient of CD34+ selected or engineered stem cell graft\n* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ\n* Severely impaired renal function defined by serum creatinine \\> 2mg\u002FdL, renal dialysis requirement.\n* Use of investigational agent within 14 days pre-HCT\n* Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months\n* Uncontrolled psychiatric illness\n* Female patient who is pregnant or breastfeeding\n* Known allergy or sensitivity to ruxolitinib",{"count":333,"type":21},40,[65],"The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).",[30],[338,339],"graft-versus-host disease (GVHD)","allogeneic hematopoietic stem cell transplant (allo-HCT)","2026-05-26",{"date":342,"type":41},"2026-05-27",{"date":344,"type":41},"2026-01-20",{"date":346,"type":21},"2029-01",{"name":348,"class":162},"Memorial Sloan Kettering Cancer Center",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":357,"targetDuration":4,"studyType":62,"phases":359,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100639005","phase-4-early-discontinuation-of-antibiotics-in-paediatric-high-risk-febrile-neutropenia-100639005","NCT07590648","Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia","Phase IV, Randomized, Open Label, Parallel Groups Clinical Trial for Evaluating the Early Stop of Antibiotic Treatment in High-risk Febrile Neutropenic Oncohaematological Paediatric Patients (e-STOP 2)","E-STOP2","Inclusion Criteria:\n\n1. Male and female patients ≤18 years of age expected to develop prolonged neutropenia (\\>7 days), with:\n\n   * Acute myeloblastic leukaemia at any phase of chemotherapy\n   * Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases\n   * Biphenotypic leukaemia at any phase of chemotherapy\n   * Lymphoblastic lymphoma in induction and consolidation phases\n   * B-cell and anaplastic lymphoma receiving high-intensity chemotherapy\n   * Solid tumours receiving high-intensity chemotherapy\n   * Relapsed leukaemia at any phase of treatment\n2. Episode of febrile neutropenia (FN), defined as a single axillary temperature ≥38.0°C in a patient with an absolute neutrophil count (ANC) \\\u003C500 neutrophils\u002Fmm³, or expected to fall below this value within the next 48-72 hours.\n3. Antibiotic treatment initiated for the current FN episode (routine antimicrobial prophylaxis is allowed, as well as teicoplanin 3 days\u002Fweek for patients with AML included in the CHIP-AML-2022 protocol and therefore in the Pro-teico study).\n4. Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following:\n\n   * CRP \\\u003C9 mg\u002FdL\n   * PCT \\\u003C0.5 ng\u002FmL\n   * Absence of hypotension\n5. No microbiologically documented bacterial infection 48-72 hours after the FN episode.\n6. Good clinical evolution 48-72 hours after the FN episode, defined as:\n\n   * Afebrile for \\>48 hours (axillary temperature \\\u003C38°C)\n   * Haemodynamically stable\n   * Stable paediatric early warning score (PEWS)\n7. CRP \\\u003C5 mg\u002FdL, or CRP \\\u003C9 mg\u002FdL and PCT \\\u003C0.5 ng\u002FmL, with decreasing trend at the time of randomisation (values will be assessed on day 3 and day 5 after the FN episode).\n8. ANC \\\u003C500 neutrophils\u002Fmm³ at the time of randomisation.\n9. Signed informed consent from the patient and\u002For parent(s)\u002Flegal representative(s).\n10. Patient and\u002For parent(s)\u002Flegal representative(s) must have sufficient reading and writing skills to understand and provide consent to participate in the study.\n11. Patient and\u002For parent(s)\u002Flegal representative(s) must be considered reliable and capable of adhering to the protocol.\n\nExclusion Criteria:\n\n1. Antibiotic treatment at the time of the FN episode different from that used prophylactically.\n2. Empirical antibiotic treatment different from that recommended in international guidelines.\n3. Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).\n4. Active participation in the same study at the onset of the current FN episode.\n5. Active participation in another clinical trial that, in the investigators' opinion, may interfere with the assessment of the results.\n6. Any condition which, in the investigator's opinion, makes study participation unsuitable for the patient or could limit, prevent, or confound the assessments planned in the protocol.\n7. Female patients who are pregnant or breastfeeding",{"count":358,"type":21},136,[360],"PHASE4","The goal of this clinical trial is to evaluate whether stopping antibiotic treatment early is safe in paediatric patients with cancer who develop high-risk febrile neutropenia but show good clinical evolution and low biomarker levels 48-72 hours after the episode.\n\nThe main questions it aims to answer are:\n\nIs early discontinuation of antibiotics as safe as the standard strategy in terms of preventing invasive bacterial infections (such as sepsis, microbiologically documented infection, ICU admission, or death)? Does this strategy reduce the number of days on antibiotics without increasing infection-related complications?\n\nResearchers will compare early antibiotic discontinuation with the standard care strategy to see whether the early-stop approach provides similar safety while reducing antibiotic exposure.\n\nParticipants will:\n\nReceive standard initial antibiotic therapy for febrile neutropenia. Undergo clinical and biomarker evaluations (including CRP and PCT).\n\nBe randomly assigned to:\n\nExperimental group: early discontinuation of antibiotics, or Control group: continuation of the standard antibiotic strategy.\n\nBe followed for 28 days after randomisation to monitor safety outcomes and treatment effects.",[363,364,30,92,365],"Febrile Neutropenia (FN)","Pediatric Cancer","Invasive Bacterial Infection",[367,368,30,92,365,369,370,371,372,373,374,375],"Febrile Neutropenia","Pediatric Oncology","Antibiotic Discontinuation","Antibiotic Stewardship","Biomarkers (CRP, PCT, IL-8)","Early Stop Strategy","Randomized Clinical Trial","Non-Inferiority Trial","Neutropenia","2026-05-13",{"date":378,"type":41},"2026-05-15",{"date":380,"type":21},"2026-06-01",{"date":382,"type":21},"2028-07-01",{"name":384,"class":162},"Hospital Universitari Vall d'Hebron Research Institute",4,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":16,"minAge":394,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":62,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":49},"100504505","phase-1-post-transplant-cyclophosphamide-in-patients-aged--65-years-undergoing-haploidentical-transplant-100504505","NCT05849207","Post-Transplant Cyclophosphamide in Patients Aged >\u002F= 65 Years Undergoing Haploidentical Transplant","IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >\u002F= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy","GeriBMT","Inclusion Criteria:\n\n* Patient age \\>\u002F= 65 years\n* Patient and related Donor (if applicable) sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility.\n* Patient meets standard criteria for allogeneic stem cell transplant\n* Patient is deemed suitable to receive Flu\u002FTBI 800 conditioning regimen as standard of care transplant\n* Donor is willing to donate peripheral blood stem cells\n\nExclusion Criteria:\n\n* Patient has a diagnosis of myelofibrosis\n* Patient has high titer antibodies (\\>10,000 mean fluorescent intensity) against one or more donor HLA antigens\n* Patient has undergone prior autologous or allogeneic stem cell transplant\n* Requiring sedation for cardiac MRIs.\n* Prohibited Implants and\u002For Devices:\n\n  * Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)\n  * Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.\n* Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.","65 Years",{"count":396,"type":21},26,[64],"The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \\>\u002F= 65 years with hematologic malignancies.",[30],[401],"Allogeneic Transplantation","2026-05-01",{"date":404,"type":41},"2026-05-07",{"date":406,"type":41},"2023-10-24",{"date":382,"type":21},{"name":409,"class":162},"Ronald Paquette",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":62,"phases":419,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":7},"100407707","phase-1-study-of-sls009-formerly-gfh009-a-potent-highly-selective-cdk9-inhibitor-in-patients-with-hematologic-malignancies-and-high-risk-newly-diagnosed-aml-100407707","NCT04588922","Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML","A Phase I\u002FIIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed\u002FRefractory Hematologic Malignancies and High-Risk Newly Diagnosed AML","Inclusion Criteria\n\nFor Groups 1, 2, 3, 4 and 5:\n\nPatients eligible for inclusion must meet all of the following criteria:\n\n1. Male or female ≥ 18 years. For Group 3 Cohorts 4 and 5 only male or female ≥18 years and pediatric patients 12-18 years and ≥40 kg body mass\n2. Written informed consent must be obtained prior to any screening procedures\n3. For AML, acute promyelocytic leukemia (APL) patients are not included in the study.\n4. Adequate hepatic function as evidenced by meeting all the following requirements:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except for patients with Gilbert's syndrome, who are included if total bilirubin is \\\u003C 3 × ULN or if direct bilirubin is \\\u003C 1.5 × ULN.\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 ×ULN.\n5. Measured or calculated (determined by the Cockcroft-Gault equation) serum creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (glomerular filtration rate can be alternative to CrCl) for adult patients or serum creatinine ≤ 1.5 x ULN; or if serum creatinine \\> 1.5 x ULN, then serum creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (estimated by Cockcroft-Gault formula or other appropriate formula) for pediatric patients. Whether the value is calculated by equation or measured directly can be based on institutional standard practice.\n6. Amylase ≤ 1.5 × ULN.\n7. Eastern cooperative oncology group (ECOG) performance status 0-2.\n8. The electrolytes and uric acid level need to be stable judged by investigators for at least 3 days before the first dose of GFH009 (Medical intervention is permitted).\n\n   For AML and other leukemias:\n\n   • Peripheral WBC counts \\\u003C 50,000\u002FµL. Cytoreduction prior to study will be allowed with hydroxyurea; hydroxyurea use will also be permitted during treatment period in patients with proliferative, progressive disease. Use of leukapheresis for the purpose of lowering WBC counts to make the patient eligible for enrolment is not permitted.\n9. Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue, \\\u003C Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy.\n10. For women of childbearing potential, she must consent to use highly effective methods (e.g., total abstinence, placement of an intrauterine device) of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug if enrolled in Group 1 and 2, and 6 months enrolled in Group 3.\n\nMen with a partner of childbearing potential, must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug.\n\nFor Groups 1, 2 and 3:\n\nPatients eligible for inclusion must meet all of the following criteria:\n\n1. Male or female ≥ 18 years. Pediatric patients ages 12-18 and ≥40 kg body mass.\n2. Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL\u002FSLL and lymphoma):\n\n   * For Lymphoma, Burkitt lymphoma, lymphoblastic lymphoma, cutaneous T-Cell lymphoma and lymphoplasmacytic lymphoma (LPL)\u002F Waldenstrom's macroglobulinemia (WM) will be excluded.\n   * Patients must not be candidates for hematopoietic cell transplant (HCT) at the time of screening.\n   * AML (only for Group 3): Patients relapsed on or refractory to venetoclax containing regimens.\n\n   Additional requirements for specific disease conditions are:\n   * CLL\u002FSLL: Peripheral blood lymphocytosis (with no other cause), CLL present on BM aspirate, or enlarged lymph node (LN), liver or spleen.\n   * Lymphoma (Except for other leukemias): At least one measurable or evaluable lesion as defined by the Lugano (2014) response criteria. Patients must have received at least 2 prior lines of systemic therapy.\n   * AML, Cohort 4 (ASXL1 mutations): AML patients relapsed on and\u002For refractory to therapies containing venetoclax combinations and with documented ASXL1 mutation.\n   * AML, Cohort 5 (Other than ASXL1 Myelodysplasia related AML defining somatic mutations): AML patients relapsed on and\u002For refractory to therapies containing venetoclax combinations and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.\n\n   Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.If any of those mutations is present concurrently with ASXL1 mutation, patients will be enrolled in Cohort 4 (ASXL1 mutation) and only patients harboring the above listed mutations without concurrent ASXL1 mutation will be enrolled in Cohort 5 (Other than ASXL1 Myelodysplasia related AML defining somatic mutations).\n3. Life expectancy ≥ 12 weeks.\n4. The following hematological clinical laboratory results during screening:\n\nFor lymphoma, CLL\u002FSLL patients:\n\n* Absolute neutrophil count: for lymphoma ≥ 1,000\u002FµL without growth factor support in the 2 weeks prior to study entry; for CLL\u002FSLL, ANC must be ≥ 500\u002FµL if myelosuppression is known to be due to BM involvement with leukemia.\n* Hemoglobin ≥ 7.5 g\u002F dL without transfusion or erythropoietin treatment in the 2 weeks prior to study entry. Patients with BM involvement will not have the threshold of hemoglobin at screening.\n* Platelet count ≥ 50,000\u002FµL without transfusion or other interventions in the 2 weeks prior to study entry.\n\nFor Groups 4 and 5:\n\nPatients eligible for inclusion must meet all of the following criteria:\n\n1. For Group 4: newly diagnosed AML patients who must meet 1 or more of the following 3 criteria:\n\n   * AML patients with AML MR (AML myelodysplasia related) as defined by WHO 5th Edition (The 5th edition of the World Health Organization Classification of Hematolymphoid Tumors: Myeloid and Histiocytic\u002FDendritic Neoplasms). Mutations include: ASXL1, BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1, and ZRSR2. Cytogenetic changes include: complex karyotype, 5q deletion or loss of 5q due to unbalanced translocation, monosomy 7, 7q deletion, or loss of 7q due to unbalanced translocation, 11q deletion, 12p deletion or loss of 12p due to unbalanced translocation, monosomy 13 or 13q deletion, 17p deletion or loss of 17p due to unbalanced translocation, isochromosome 17q, idic(X)(q13)); and\u002For\n   * AML MM (AML with myelomonocytic\u002F myelomonoblastic differentiation per FAB M4\u002FM5) and\u002For\n   * Mayo 2024 HR\u002FVHR (Mayo Genetic Risk Models for Newly Diagnosed Acute Myeloid Leukemia Treated With Venetoclax + Hypomethylating Agent. High Risk is defined as ≥2 points where points are: ELN 2022 Adverse Karyotype: 1 point; IDH2wt: 1 point; TP53mut: 1 point; KRASmut: 1 point; KMT2A rearrangement: 2 points).\n2. Group 5: First-line AML patients who have failed to achieve CR, CRi, or MLFS after the first 2 cycles of azacitidine\u002Fvenetoclax (defined as ≥5% blasts in bone marrow or presence of circulating blasts after 2 cycles of azacitidine and venetoclax).\n3. Life expectancy ≥6 weeks.\n\nExclusion Criteria\n\nFor Groups 1, 2, 3, 4 and 5:\n\nPatients eligible for inclusion must not meet any of the following criteria:\n\n1. Uncontrolled medical conditions such as hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), a history of hypertensive crisis, or a history of hypertensive encephalopathy.\n2. History of previous exposure to any other CDK9 inhibitors.\n3. Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.\n4. Severe cardiovascular disease within 6 months of study entry, including any of the following:\n\n   * Clinically significant heart disease such as congestive heart failure requiring treatment (NYHA class III or IV), left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by MUGA scan or echocardiogram (ECHO), (if only with historical occasional low LVEF but without any symptoms or relevant medical history, and the LVEF at screening is \\> 50%, the subject is eligible), or clinically significant arrythmia.\n   * History\u002Fevidence of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting).\n   * Average QTcF ≥ 450 msec (males) or ≥ 470 msec (females) on screening ECG.\n   * Moderate or above regurgitation on echocardiogram\n5. Patients with prior treatment with cardiotoxic agents who have experienced drug induced cardiotoxicities during or after treatment, where cardiotoxic agents include but are not limited to anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin, mitoxantrone); trastuzumab and trastuzumab based ADCs; tyrosine kinase inhibitors (sunitinib, imatinib); alkylating agents (cyclophosphamide).\n6. Patients who are on systemic antibiotics are eligible to participate as long as the antibiotics are not expected to have significant DDI with GFH009 (A list of approved concomitant medications will be provided to investigators. If any antibiotic is not included in the approved list, it can be discussed with the sponsor or designated CRO on a case-by-case basis).\n7. Active hepatitis B or hepatitis C virus infection. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy have to be on a suppressive antiviral therapy prior to enrollment.\n\n   Patients with HCV may be enrolled if the HCV is stable, and the patient is not at risk for hepatic decompensation.\n\n   Patients with known HIV infection except if:\n   * They have CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL, and\n   * No history of AIDS-defining opportunistic infections within the last 12 months preceding screening, and\n   * Are on established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n8. Concomitant medications that are strong CYP3A4 inhibitors or strong inducers within 7 days prior to the first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pomelos, star citrus fruits or St. John's wort within 7 days of first dose.\n9. Stroke or intracranial hemorrhage within 6 months.\n10. Major surgery within 4 weeks prior to study entry.\n11. Pregnant or breast-feeding females.\n12. Prior allogeneic stem cell transplant within 6 months of study entry. Patients who received autologous HCT, if considered to be enrolled and must be \\> 3 months post-transplant and meet hematologic inclusion criteria.\n13. Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.\n14. Medications that are known to prolong the QT interval that could not be stopped prior to study entry judged by investigator, except azole antifungal medications in AML patients.\n\nFor Groups 1, 2 and 3:\n\nPatients eligible for inclusion must not meet any of the following criteria:\n\n1. For AML and other leukemias: Systemic chemotherapy or demethylating agent therapy within 7 days, or targeted therapy within 7 days or 5 half-lives whichever is shorter, or immunotherapy within 4 weeks, or CAR-T therapy within 12 weeks before the first dose. If a patient is receiving high dose cytarabine, liposomal cytarabine, or standard dose cytarabine (100-200 mg\u002Fm2\u002Fday), the patient must be off the drug for at least 2 weeks or until the patient has recovered from toxic effects. Patients in Group 3 are allowed to have received venetoclax and\u002For hypomethylating agents (HMAs) prior to screening and will continue receiving venetoclax in combination with azacitidine throughout the duration of the trial. No washout from HMAs and\u002For venetoclax is required for this group.\n\n   For lymphoma and CLL\u002FSLL: Patients who have received chemotherapy or targeted therapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) or 5 half-lives whichever is shorter, or immunotherapy (e.g., CD20 monoclonal antibody, CD38 monoclonal antibody, PD1 or PD-L1 antibody) within 4 weeks, or CAR-T therapy within 12 weeks prior to starting study drug.\n2. Patients with bulky disease (≥ 10 cm) who require cytoreductive therapy.\n3. Radiotherapy with wide field radiation within 28 days or radiotherapy with a limited field of radiation for palliation within 7 days of the first dose.\n4. Symptomatic central nervous system (CNS) metastases or primary lymphoma such as primary CNS lymphoma, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy and are on a stable or decreasing dose of corticosteroids are eligible for study entry.\n5. Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day. Inhaled and topical steroids are allowed.\n6. Patients with a baseline cardiac biomarker abnormality (CKMB\u002FcTnI) will be excluded.\n7. Patients with hypereosinophilic syndrome defined as eosinophil counts in peripheral blood of ≥1,500\u002Fµ.\n8. Pulmonary embolism within 6 months before study entry. Patients with a history of other clinically venous or arterial thrombotic events that the investigator feels puts the patient at risk for participation in the study (based on overall status, medical history, or other factors) will be excluded.\n9. Concurrent malignancy within 5 years (for AML patients, 2 years) prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma (excluding T1 lesions and CIS).\n10. For AML patients only: Given that GFH009 is a CYP3A4 substrate and the critical role of azole antifungals (commonly strong CYP3A4 inhibitors) in the treatment of patients with AML, if use of azole antifungals is necessary for the patients in AML groups, and if azoles cannot be substituted with alternative antifungal drugs (e.g., caspofungin, amphotericin B etc.), use of isavuconazole, the only azole antifungal that is a moderate CYP3A4 inhibitors and does not prolong QT interval, is recommended. Other azoles are allowed if deemed necessary by the investigator. If azoles are used, AML patients receiving azole antifungals will be subject to enhanced monitoring plan provided in section 6.5.2. PK of GFH009 will be compared in patients with coadministration of azole antifungals versus those without azole antifungals.\n11. Subjects with high risk of gastrointestinal hemorrhage, including but not limiting to active ulcer with fecal occult blood test ≥++; history of hematemesis or melena within 2 months prior first dose.\n\nFor Groups 4 and 5:\n\nPatients eligible for inclusion must not meet any of the following criteria:\n\n1. For patients in Group 4, no prior anti-leukemic therapy is allowed, except for ATRA if used for suspected APL, or hydroxyurea or cytarabine if used emergently for emergent cytoreduction or disease stabilization (a maximum total cumulative dose of cytarabine 1 g).\n\n   For patients in Group 5, no prior antileukemic therapy except venetoclax and azacitidine for exactly 2 cycles is allowed prior to screening. Patients will continue receiving venetoclax in combination with azacitidine throughout the duration of the trial. No washout from azacitidine and venetoclax is required.\n2. For AML Group 4: presence of favorable risk cytogenetic markers including: NPM1-mutations (with FLT3-ITDneg, NRASwt, KRASwt, TP53wt); IDH2-mutations (with FLT3-ITDneg, NRASwt, KRASwt, TP53wt); IDH1-mutations (with TP53wt); AML with DDX41-mutations is excluded.\n3. Patients with a history of clinically significant venous or arterial thrombotic events that the investigator feels puts the patient at risk for participation in the study (based on overall status, medical history, or other factors) will be excluded.\n4. Concurrent malignancy within 2 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma (excluding T1 lesions and CIS).\n5. Concurrent malignancy within 2 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma (excluding T1 lesions and CIS).\n6. Given that GFH009 is a CYP3A4 substrate and the critical role of azole antifungals (commonly strong CYP3A4 inhibitors) in the treatment of patients with AML, if use of azole antifungals is necessary for the patients in AML groups, and if azoles cannot be substituted with alternative antifungal drugs (e.g., caspofungin, amphotericin B etc.), use of isavuconazole, the only azole antifungal that is a moderate CYP3A4 inhibitors and does not prolong QT interval, is recommended. Other azoles are allowed if deemed necessary by the investigator.",{"count":418,"type":21},160,[64,65],"SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed\u002Frefractory AML, Group 2 in patients with relapse\u002Frefractory lymphoma\u002FCLL\u002FSLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed\u002Frefractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.",[30],[423,424,425,426,427,428,429,430,431,432,433,434,435,436,437],"Acute Myeloid Leukemia,","AML","Lymphoma","Chronic Lymphocytic Lymphoma","CLL","Small Lymphocytic Lymphoma","SLL","relapsed","refractory","CDK9 inhibitor","GFH009","SLS009","venetoclax","azacitidine","ASXL1","2026-04-29",{"date":402,"type":41},{"date":441,"type":41},"2021-05-10",{"date":443,"type":21},"2027-12-31",{"name":445,"class":115},"Sellas Life Sciences Group",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":62,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":49},"100578154","phase-2-optimized-cord-blood-transplantation-for-the-treatment-of-patients-with-high-risk-hematologic-malignancies-who-have-relapsed-after-first-allogeneic-stem-cell-transplantation-100578154","NCT06807606","Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation","Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT","Inclusion Criteria:\n\n1. Patient aged 0-60 y\u002Fo at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.\n2. Patient must have relapsed \\>100 days since first transplant.\n3. Diagnosis and Disease Status:\n\n   a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (\\\u003C5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular aberrations, or those with hypocellular marrows at time of transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those or who have hypocellular bone marrows, are eligible. c. Other acute leukemias: i. Acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those who have hypocellular bone marrows, are eligible. d. Myelodysplastic Syndromes (MDS) or CMML without myelofibrosis. i. Includes MDS with any IPSS risk category.\n4. Prior treatment:\n\n   a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.\n5. Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).\n6. Renal and Liver function:\n\n   1. Calculated creatinine clearance \\> 50 ml\u002Fmin.\n   2. Bilirubin \\\u003C 2 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n   3. ALT \\\u003C 5 x upper limit of normal (ULN).\n7. Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.\n8. Left ventricular ejection fraction (MOD-bp) \\> 50%.\n9. Graft Criteria:\n\n   1. Two CB units will be selected according to the current MDACC CB unit selection algorithm.\n   2. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed.\n   3. Unit selection will occur based on HLA-match, total nucleated cell (TNC), and CD34+ cell dose adjusted per patient body weight.\n   4. The bank of origin will also be considered.\n   5. Donor-specific HLA antibodies, if present, will also be taken into consideration.\n   6. Each CB unit must be at least 3\u002F8 HLA-matched to the patient considering high-resolution 8-allele HLA typing.\n   7. Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 107 TNC\u002F recipient body weight (TNC\u002F kg).\n   8. Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 105 CD34+ cells\u002F recipient body weight (CD34+ cells\u002Fkg).\n   9. A minimum of one unit will be reserved as a backup graft.\n   10. Each CB unit will be required to be cryopreserved in standard cryovolume. (24- 27 ml\u002Fs per unit) and be red blood cell depleted.","60 Years",{"count":455,"type":21},35,[65],"The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.",[30],"2026-04-23",{"date":461,"type":41},"2026-04-28",{"date":463,"type":41},"2025-03-03",{"date":465,"type":21},"2029-11-30",{"name":467,"class":162},"M.D. Anderson Cancer Center",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":62,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":489},"100567201","phase-2-pul-042-treatment-in-patients-with-parainfluenza-virus-piv-human-metapneumovirus-hmpv-or-respiratory-syncytial-virus-rsv-100567201","NCT06665100","PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)","Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV","Inclusion Criteria:\n\n* Subjects will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) by molecular assay by a local laboratory AND subjects must fulfill the following inclusion criteria to be eligible for participation in the study:\n\n  1. Subjects with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder.\n  2. Subjects who have undergone active cytotoxic chemotherapy within 6 months or subjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids ≥1mg\u002Fkg prednisone equivalent).\n  3. Subjects who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index (ISI) , of greater or equal to 4.\n  4. Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.\n  5. Subjects must be symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough and must be dosed within 6 days from the onset of symptoms.\n  6. Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.\n  7. Subjects must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.\n  8. Spirometry (forced expiratory volume in one second \\[FEV1\\] and forced vital capacity \\[FVC\\]) ≥70% of predicted value.\n  9. Adult (≥ 18 years of age).\n  10. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\n  11. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\n  12. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\n  13. Ability to understand and give informed consent.\n\nExclusion Criteria:\n\n* Subjects will be excluded if they fulfill any of the following exclusion criteria:\n\n  1. Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.\n  2. Known history of chronic pulmonary disease (e.g., asthma \\[including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection\\], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\n  3. Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days.\n  4. Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever is longer, prior to the Screening Visit.\n  5. Allogeneic HSCT recipients with an ISI of 3 or less.\n  6. Autologous HSCT recipients more than 3 months after the transplant procedure.\n  7. Patients with a relapsed and\u002For refractory underlying hematologic malignancy with a life expectancy of less than 2 months.\n  8. HSCT recipients in the pre-engraftment period.\n  9. Chest X-ray with an RSI of \\>6.\n  10. Patients documented to be positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to the Screening Visit, as determined by local testing (additional screening testing is not required).\n  11. Clinically significant bacteremia or fungemia within 7 days prior to the Screening Visit that has not been adequately treated, as determined by the Principal Investigator.\n  12. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\n  13. Previous exposure to PUL-042 Inhalation Solution.",{"count":476,"type":21},100,[65],"The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.",[30,480],"Hematopoietic Stem Cell Transplant (HSCT)",{"date":482,"type":41},"2026-04-24",{"date":484,"type":41},"2025-06-27",{"date":486,"type":21},"2027-05",{"name":488,"class":115},"Pulmotect, Inc.",11,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":62,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":49},"100587300","phase-2-allogeneic-hsct-with-low-dose-post-transplant-cyclophosphamide-for-gvhd-prevention-100587300","NCT06926595","Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention","Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies","GVHD-PTCy","Inclusion Criteria:\n\n* Age 18 or older at the time of study enrollment.\n* Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.\n\nFlow cytometric, polymerase chain reaction (PCR) or next generation sequencing (NGS) detected measurable residual disease is permitted.\n\n* Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with \\\u003C5% vs 5-10% blasts in this disease).\n* Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS\u002FMPN overlap syndrome.\n* Patients with relapsed or refractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.\n* Patients with lymphoma who are indicated for allogeneic stem cell transplantation, including follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma (including primary mediastinal B cell lymphoma), mantle cell lymphoma, peripheral T cell lymphomas, and Richter's transformation.\n* Planned reduced intensity or non-myeloablative conditioning regimen.\n* Patients must have a related or unrelated peripheral blood stem cell donor as follows:\n\nSibling donor must be at least haploidentical using high resolution DNA-based HLA typing.\n\nChildren or parent donor must be at least haploidentical using high resolution DNA-based HLA typing. Children donors must be at least 18 years of age at the time of evaluation.\n\nUnrelated donors must be a 7\u002F8 or 8\u002F8 match at HLA-A, B, C, and DRB1 at high resolution using DNA based typing.\n\n* Cardiac function: must demonstrate at ejection fraction of at least 40%.\n* Pulmonary function: must have FEV1 of at least 50% predicted, and DLCO corrected for hemoglobin of at least 40% predicted.\n* Karnofsky performance status at least 70%.\n* Women of childbearing potential (WOCP), defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy) or at least 1 year postmenopausal, must have a negative serum pregnancy test before conditioning regimen.\n* Female patients (unless post-menopausal or surgically sterilized) must agree to practice two effective methods of contraception simultaneously or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 12 months post-transplant.\n* Male patients (even if surgically sterilized) who are partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n\nExclusion Criteria:\n\n* Prior allogeneic stem cell transplant.\n* Active central nervous system (CNS) involvement by malignant cells.\n* Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).\n* Seropositive for human immunodeficiency virus (HIV) with detectable viral load, hepatitis B virus (HBV) or hepatitis C virus (HCV) with detectable viral load. Hepatitis B surface antibody positive due to vaccination or natural immunity are permitted. Patients previously treated for HCV and considered to be in sustained virologic remission (SVR) are allowed.\n* Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.\n* Pregnant or lactating female patients (unless feeding via formula). Women of childbearing potential (WOCBP) are required to have a negative serum or urine pregnancy test prior to conditioning regimen.\n* Serious medical or psychiatric illness likely to interfere with participation in the study.\n* Use of investigational agents.\n* Haploidentical related recipient who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex).\n* Any patient with steroid dose more than 10 mg\u002Fday within a week of registration.\n* Autoimmune disorder requiring any active immunosuppression therapy.",{"count":499,"type":21},41,[65],"This Phase 2, single-arm, open-label study aims to evaluate the safety and efficacy of low-dose (25 mg\u002Fkg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) in patients undergoing allogeneic stem cell transplantation following reduced-intensity or non-myeloablative conditioning. The study will focus on matched sibling, matched unrelated, and haploidentical peripheral blood stem cell donors. The primary endpoint is 1-year GVHD-Free Relapse-Free Survival (GRFS). The study seeks to determine if low-dose PTCy offers similar outcomes as higher doses, with potentially reduced toxicity.",[503,30,504],"Graft-versus-Host Disease (GVHD)","Allogeneic Stem Cell Transplantation","2026-03-30",{"date":507,"type":41},"2026-04-03",{"date":509,"type":41},"2026-03-09",{"date":511,"type":21},"2031-11-01",{"name":513,"class":162},"Milton S. Hershey Medical Center",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":520,"targetDuration":522,"studyType":22,"phases":4,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":49},"100244252","mayo-clinic-radiotherapy-patient-outcomes-registry-and-biobanking-study-100244252","NCT02457962","Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study","Inclusion Criteria:\n\n1. Treated with photon\u002Fproton at Mayo Clinic Rochester in Radiation Oncology\n2. Radiation therapy for curative intent\n\nExclusion Criteria:\n\nNone",{"count":521,"type":21},15000,"100 Years","To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon\u002Fproton therapy.",[92,30],"2026-03-27",{"date":527,"type":41},"2026-04-01",{"date":529,"type":41},"2015-04-23",{"date":531,"type":21},"2031-04-30",{"name":533,"class":162},"Mayo Clinic",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":57,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":541,"targetDuration":543,"studyType":22,"phases":4,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":555},"100404483","aberrant-expression-of-cd56-in-patients-with-hematologic-malignancies-100404483","NCT04546945","Aberrant Expression of CD56 in Patients With Hematologic Malignancies.","Resident Doctor at Clinical Pathology Department","Inclusion Criteria:\n\n* Patients with hematologic malignancies.\n* Newly diagnosed\n\nExclusion Criteria:\n\n* Patients with hematologic disorders other than hematologic malignancies.",{"count":542,"type":21},38,"12 Months","CD56(cluster of differentiation 56) was found to be ectopically expressed in multiple myeloma . A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.",[30],"2026-03-17",{"date":548,"type":41},"2026-03-18",{"date":550,"type":21},"2027-03-20",{"date":552,"type":21},"2027-12-30",{"name":554,"class":162},"Asmaa Hassan mohamed Abdel Mawjoud",2,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":16,"minAge":453,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":62,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100626925","phase-2-the-safety-and-efficacy-of-the-regimen-of-thiotepa--fludarabine-granulocyte-colony-stimulating-factor-cytarabine--busulfan-in-single-unrelated-umbilical-cord-blood-transplantation-100626925","NCT07441967","The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation","A Prospective, Single-arm, Single-center, Open-label Clinical Study on the Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation for Elderly Patients With Hematologic Malignancies","Inclusion Criteria:\n\n* Aged between 60 and 69 years old (inclusive), gender not restricted.\n* Patients with hematological malignancies who plan to receive a single unrelated umbilical cord blood transplantation treatment\n* The liver and kidney functions, as well as the heart and lung functions, must meet the following requirements:\n\n  1. Serum creatinine ≤ 1.5 × ULN\n  2. Cardiac function: Ejection fraction \\> 50%\n  3. Baseline oxygen saturation \\> 92%\n  4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN\n  5. Pulmonary function: DLCO (hemoglobin-corrected) \\> 65% and FEV1 \\> 65%\n* ECOG PS≤2\n* HCT-CI≤2\n* Expected survival period ≥ 6 months\n* By signing the informed consent form, one voluntarily participates in this study and is willing and able to cooperate with the data collection in this research.\n\nExclusion Criteria:\n\n* For those who are allergic to the drugs and their related metabolites\n* Any unstable systemic diseases: including but not limited to stable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification ≥ 3), severe arrhythmias requiring drug treatment, liver, kidney or metabolic diseases; patients with pulmonary hypertension; or diseases that, in the judgment of the investigator, pose a serious threat to the safety of the patient or affect the patient's ability to complete the study.\n* Active and uncontrolled infection: Hemodynamic instability related to the infection, or new symptoms or signs of infection appear, or new infection lesions are found on imaging, or persistent fever without symptoms or signs that cannot rule out the presence of an infection.\n* The patient is currently involved in a clinical intervention study\n* The patient is unable to understand the nature of the study or has not given informed consent\n* Other circumstances where the researcher deems the patient unsuitable for inclusion in this study","69 Years",{"count":565,"type":21},44,[65],"This trial is a prospective, single-arm, single-center clinical study. A total of 44 elderly (aged 60 to 69 years) patients with hematological malignancies who need to receive a single-unit unrelated umbilical cord blood transplantation (UCBT) are planned to be enrolled. After screening and enrollment, patients are scheduled to receive the following drug treatment regimen: Thiotepa 5 mg\u002Fkg every 12 hours on day -8; Granulocyte Colony-Stimulating Factor(G-CSF) 5 ug\u002Fkg\u002Fday from day -8 to -5; Cytarabine 1.5 g\u002Fm2 from day -7 to -5; Fludarabine 30 mg\u002Fm2\u002Fday from day -7 to -4; Busulfan 0.8 mg\u002Fkg every 6 hours from day -4 to -2. Umbilical cord blood hematopoietic stem cells are reinfused on day 0. Routine monitoring of blood routine is conducted, and platelets and red blood cells are transfused when necessary.",[30],[570,571],"Unrelated Umbilical Cord Blood Transplantation","Regimen","2026-02-26",{"date":574,"type":41},"2026-03-02",{"date":576,"type":21},"2026-02-20",{"date":578,"type":21},"2028-12-30",{"name":580,"class":162},"Institute of Hematology & Blood Diseases Hospital, China",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":62,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":385},"100595721","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-pralatrexate-in-patients-with-advanced-solid-tumor-or-hematological-malignancy-and-either-normal-hepatic-function-or-mild-moderate-or-severe-hepatic-impairment-100595721","NCT07036133","Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment","A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment","SPI-FOL-102","Inclusion Criteria:\n\n* Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements\n* Patient is diagnosed with advanced solid tumor or hematological malignancy.\n* Patient is at least 18 years of age and has a life expectancy of at least 6 months.\n* Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment\n* Patient has adequate hematologic and renal function as defined by:\n\nAbsolute neutrophil count (ANC) ≥1000\u002FμL Platelet count ≥100,000\u002FμL Creatinine ≤ 1.5 mg\u002FdL or calculated creatinine clearance ≥50 mL\u002Fmin\n\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of pralatrexate\n* Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.\n\nExclusion Criteria:\n\n* Patient has had previous exposure to pralatrexate\n* Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.\n* Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.\n* Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.\n* Patient has congestive heart failure at Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification\n* Patient has had major surgery within 30 days prior to enrollment.\n* Patient with central nervous system (CNS) metastases\n* Patient is pregnant or breast-feeding.",{"count":590,"type":21},24,[64],"This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.",[594,30],"Advanced Solid Tumors",[596],"Pralatrexate","2026-02-10",{"date":599,"type":41},"2026-02-11",{"date":601,"type":41},"2022-12-28",{"date":603,"type":21},"2027-09",{"name":605,"class":115},"Acrotech Biopharma Inc.",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":62,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":49},"100518306","phase-2-risk-adapted-conditioning-regimen-for-allogeneic-hematopoietic-stem-cell-transplantation-100518306","NCT06028828","Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation","Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)","ADAPT","Inclusion Criteria:\n\n1. Male or female aged 18-70 years\n2. Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT\n3. Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)\n4. Karnofsky performance \\>70%\n5. Adequate major organ system function as demonstrated by:\n\n   1. Serum creatinine clearance equal or more than 50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n   2. Bilirubin equal or less than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST equal or less than 200 IU\u002Fml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.\n   3. Left ventricular ejection fraction equal or greater than 40%.\n   4. Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.\n6. Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n1. Inability to comply with medical recommendations or follow-up\n2. Pregnancy\n3. Active\u002Funcontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)\n4. Has active CNS or ocular disease involvement within 3 months\n5. Patients with primary CNS lymphoma\n6. Patients who require modifications of the conditional regimen","70 Years",{"count":616,"type":21},60,[65],"This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.",[620,504,30],"Allogeneic Hematopoietic Stem Cell Transplantation",[620,622,623,624,625,626],"Allogeneic Stem Cell transplantation","AHSCT","Hematologic malignancies","Melphalan","Hematopoietic stem cell transplant -composite risk","2026-01-29",{"date":629,"type":41},"2026-02-02",{"date":631,"type":41},"2023-09-11",{"date":603,"type":21},{"name":634,"class":162},"University of California, Irvine",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":62,"phases":645,"briefSummary":646,"conditions":647,"keywords":648,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":660},"100574220","phase-1-this-study-is-a-fih-study-which-is-required-to-understand-the-pk-characteristics-mtd-rp2d-and-safety-profile-100574220","NCT06756451","This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RJK-RT2831 Injection in Patients With Hematologic Malignancies.","Inclusion Criteria:\n\n* 1\\. A male or female aged ≥ 18 and \\\u003C75 years old.\n* 2\\. The following three points are evaluated by the investigator and are deemed suitable to participate in the study: a) The subject fully understands the requirements of this study and voluntarily signs a written informed consent form; b) Be able to comply with the medication requirements of this study as well as all study related procedures and assessments; c) Not deemed as potentially unreliable and\u002For uncooperative.\n* 3\\. An ECOG physical status score is ≤ 2 and an expected survival is ≥ 3 months.\n* 4\\. Relapsed or refractory acute myeloid leukemia (AML) that meets the following criteria will be included in Phase Ⅰa : Patients diagnosed with AML according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours: -Myeloid and Histiocytic\u002FDendritic Neoplasms (Khoury et al., 2022), including any subtype except for acute promyelocytic leukemia (APL). These patients must have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit.\n\nNote: The following diagnostic criteria must be met for relapsed\u002Frefractory AML: (1) Relapsed AML: Leukemia cells reappear in the peripheral blood or bone marrow blast cells exceed 5% after complete remission (CR) (excluding reasons such as bone marrow regeneration post-consolidation chemotherapy) or there is extramedullary infiltration by leukemia cells. (2) Refractory AML: Initial cases that are unresponsive after two cycles of standard regimen treatment; recurrence within 12 months after CR and consolidation therapy; recurrence beyond 12 months with ineffectiveness of conventional chemotherapy; those who have relapsed twice or more; or persistent extramedullary leukemia.;\n\n-5. Phase Ib tentatively includes patients with hematologic malignancies that meet the following criteria: relapsed or refractory AML subjects who have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit, and MDS subjects who are diagnosed according to the 5th edition of the WHO Classification of Haematolymphoid Tumours-Myeloid and Histiocytic\u002FDendritic Neoplasms (Khoury et al., 2022) and are classified as high-risk or very-high-risk according to the Revised International Prognostic Scoring System (IPSS-R) (Greenberg et al., 2012). The specific tumor type will be determined based on the results of the Phase Ia trial and may be extended to other hematologic malignancies.\n\nNote: Subjects with myelodysplastic syndromes with excess blasts (MDS-EBs) type 1 (MDS-EB1) or type 2 (MDS-EB2) may be considered for inclusion. The EB type has a higher risk of transformation to AML than other subtypes and may have greater clinical benefits.\n\n* 6\\. The test of CD33 and\u002For CD123 for Phase Ia and Ib subjects in this study will be required to be positive, and patients with any level of CD33 and\u002For CD123 positivity were allowed to be included. Note: The positivity and expression levels of CD33 and CD123 were determined by each site.\n* 7\\. Consent to bone marrow biopsy and aspiration, and consent to implantation of medical devices such as peripherally inserted central catheter (PICC), or venous access port, or central venous catheter (CVC) (if applicable) for long-term intravenous drug administration.\n* 8\\. Patients have recovered from toxicity of prior first-line therapy, i.e., Grade 1 toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, with the exception of toxicities such as alopecia, fatigue, and other toxicities deemed by the investigator to be of no safety risk to the patient, as well as hematological toxicities related to the tumor.\n* 9\\. Substantial normal function of major organs with screening laboratory tests meeting the following criteria:\n\n  1. Bone marrow function: white blood cell count ≤ 30×10\\^9\u002FL;\n  2. Liver function: TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN;\n  3. Renal function: creatinine clearance rate (CCr) \\> 50 mL\u002Fmin calculated according to the Cockcroft-Gault method\n  4. Coagulation function: activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5×ULN.\n* 10\\. The serum pregnancy test for female patients of childbearing potential should be negative during the screening period. Male and female patients of childbearing potential must agree to use effective methods of contraception from signing an informed consent form during the screening period, throughout the study and for 3 months after the last dose of the RJK-RT2831, including but not limited to: abstinence, vasectomy in males, female sterilization surgery, effective intrauterine contraceptive devices or condoms, and effective contraceptive medications.. Note: Women of non-childbearing potential include permanent infertility (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) and postmenopausal women.\n\nExclusion Criteria:\n\n* 1\\. APL is suspected or confirmed based on morphology, immunophenotyping, molecular testing, or chromosomal karyotyping, or other hematological tumors, such as myeloid sarcoma, mixed phenotype acute leukemia, accelerated phase and blast phase of chronic myeloid leukemia, etc.;\n* 2\\. Has received any anticancer therapy or investigational drug within the following specified time period prior to the first dose of RJK-RT2831:\n\n  1. Received cytotoxic chemotherapy (except hydroxyurea use for subjects with leukocytosis \\>10,000 cells\u002Fmm3 or rapid disease progression), radiotherapy (except local palliative radiotherapy), immunotherapy, targeted therapy and other anti-tumor treatments within 14 days;\n  2. Received adoptive cell therapy, such as autologous or donor natural killer cell or T lymphocyte infusions (e.g., chimeric antigen receptor-T cells), unless \\> 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1;\n  3. Received any investigational drug (for any indication) within 5 half-lives of the drug or 14 days, whichever is longer;\n  4. Received an autologous haematopoietic stem cell transplant within 12 weeks.\n* 3\\. Subjects with cardiovascular disease, including but not limited to:\n\n  1. Resting state, mean QTcF \\> 480 ms in men\u002Fwomen derived from 12-lead electrocardiogram (ECG) (repeated 3 times); Note: QTcF = QTcB ×RR\\^0.17, QTcB is the corrected QT interval obtained using the Bazetts correction formula;\n  2. Echocardiogram or multigated acquisition (MUGA) scan showing a left ventricular ejection fraction of less than 50%;\n  3. Symptomatic or treatment-requiring abnormalities in rhythm, conduction, and resting ECG morphology, such as arrhythmias, degree II or III atrioventricular block, congestive heart failure (New York Heart Association cardiac function class III or IV)\n  4. New onset of angina pectoris and myocardial infarction within 6 months prior to initiation of study treatment;\n  5. Various factors that may increase the risk of prolonged QTc, such as congenital long QT syndrome, having long QT syndrome in the immediate family history, and being on any medications known to prolong the QT interval.\n  6. History of cerebral perfusion (e.g., carotid artery stenosis) or stroke or transient ischemic attack within 6 months prior to screening.\n* 4\\. Subjects with an evidence of infectious disease, including:\n\n  1. Hepatitis B surface antigen (HBs Ag) positive, and hepatitis B virus deoxyribonucleic acid (HBV DNA) copy number greater than the normal upper limit;\n  2. Hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus ribonucleic acid (HCV RNA) levels greater than the normal upper limit;\n  3. infected with human immunodeficiency virus (HIV);\n  4. Treponema pallidum (Tp) antibody positive;\n  5. Known active tuberculosis.\n* 5\\. Subjects with leukemic extramedullary infiltration.\n* 6\\. Subjects with long-term steroid therapy, except for the following: 10 mg of prednisone daily (or equivalent) or lower dose steroids for the control of nausea, vomiting, seasonal allergies, or for the prevention of adrenocortical insufficiency. Subjects who require \\> 10 mg of prednisone for a long time (e.g., more than 2 months) need to be excluded.Note: Topical steroids or inhaled steroids are permitted.\n* 7\\. Subjects with autoimmune hemocytopenia that the investigator assessed as requiring active intervention, e.g. autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura.\n* 8\\. Subjects who have undergone major surgical procedures (craniotomy, thoracotomy, laparotomy, vascular intervention, other as defined by the investigator) or have unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose of RJK-RT2831. Note: For palliative care purposes, local surgical treatment of isolated lesions is acceptable.\n* 9\\. Subjects with uncontrolled co-morbidities such as:\n\n  1. Severe infection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; or patients who have received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, except who have received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease). If it is not an active infection and the infection is controllable, the subjects can be enrolled;\n  2. Other malignancies (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence) within 5 years prior to initiation of RJK-RT2831 treatment or concurrently;\n  3. Subjects with current cancerous meningitis, spinal cord compression, etc.;\n  4. A history of poorly controlled hypertension (abnormal blood pressure measured 3 times to take the mean, systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n  5. Other acute or chronic illnesses or abnormal laboratory test values that may result in an increase in the risk associated with study participation or investigational drug administration, or interfere with the interpretation of study results;\n* 10\\. Subjects who are expected to receive other anti-tumor therapy during the study (palliative radiotherapy is allowed).\n* 11\\. Subjects with prior therapy using gemtuzumab ozogamicin or other CD33-targeting agents, or who have experience with CD33-targeting compounds in the clinical trial phase.\n* 12.Subjects with prior therapy using tagraxofusp or other CD123-targeting agents, or who have experience with CD123-targeting compounds in the clinical trial phase.\n* 13.Subjects who are allergic to prescription components of the RJK-RT2831 formulation (histidine, histidine hydrochloride, sucrose, Poloxam 188).\n* 14.Subjects who are pregnant or lactating women.\n* 15.Subjects who have received other investigational drugs within 2 cycles prior to medication, or are concurrently participating in another interventional clinical study (unless they are participating in an observational study or are in the follow-up phase of an interventional study).\n* 16.Subjects with a previous history of receiving allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.\n* 17\\. In the opinion of the investigator, the subject has other factors that may affect the results of the study and interfere with his\u002Fher participation throughout the study, including previous or existing medical conditions, laboratory abnormalities, and the subject's unwillingness to comply with the processes, restrictions, and requirements of the study.","74 Years",{"count":644,"type":21},71,[64],"This study is a first-in-human (FIH) study which is required to understand the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies",[30],[649,650],"RT-RT2831","Malignancies","2026-01-28",{"date":653,"type":41},"2026-01-30",{"date":655,"type":41},"2025-03-25",{"date":657,"type":21},"2028-07-14",{"name":659,"class":115},"Nanjing RegeneCore Biotech Co., Ltd.",16,{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":62,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":49},"100607256","phase-3-digital-health-intervention-for-self-management-and-telemonitoring-in-chimeric-antigen-receptor-car-t-therapy-100607256","NCT07186192","Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy","Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy","Inclusion Criteria:\n\nPatient Inclusion Criteria Informed Consent and Willingness to Participate\n\n1. Documented informed consent of the participant and\u002For legally authorized representative Age and Language Criteria\n2. Age ≥ 18 years old at the time of enrollment\n3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria\n4. Relapsed or refractory hematologic malignancy\n5. Scheduled to receive outpatient standard of care (SOC) CAR-T therapy\n6. Has a FCG committed to living with the patient for the duration of the study\n\nFamily Caregiver Inclusion Criteria Informed Consent and Willingness to Participate\n\n1. Documented informed consent of the participant and\u002For legally authorized representative Age and Language Criteria\n2. Age ≥ 18 years old at the time of enrollment\n3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria\n4. Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care\n\nExclusion Criteria 1. An employee who is under the direct\u002Findirect supervision of the PI\u002F a co-investigator\u002F the study manager 2. A direct study team member\n\n\\-",{"count":669,"type":21},190,[174],"The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).",[30],[674,675],"CAR-T","Digital health intervention","2026-01-27",{"date":651,"type":41},{"date":679,"type":41},"2026-01-14",{"date":681,"type":21},"2029-03-29",{"name":683,"class":162},"City of Hope Medical Center"]