[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neutropenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neutropenia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,49,86,127,149,172,200,220,245,272,295,322,351,375,408,434,460],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100130517","phase-1-a-phase-i-study-of-mozobil-in-the-treatment-of-patients-with-whims-100130517",false,"NCT00967785","A Phase I Study of Mozobil in the Treatment of Patients With WHIMS","A Phase I Study of MozobilTM in the Treatment of Patients With WHIMS","* INCLUSION CRITERIA:\n\nAll of the following inclusion criteria must be met for a subject to be enrolled in this study:\n\n* Clinical diagnosis of WHIMS and documented severe infection\n* Must be greater than or equal to 18 and less than or equal to 75 years of age\n* Willingness to interrupt medications to raise the white count (WBC) such as G-CSF or GM-CSF for at least 2 days before and while on the study drug\n* Must not be pregnant or breastfeeding\n* Must have a personal physician\n* Must be willing to provide blood, plasma, serum, and DNA samples for storage\n* Subjects must agree not to become pregnant or to impregnate a female. If of childbearing potential, must agree to consistently use two types of contraception throughout study participation. Acceptable forms of contraception include the following:\n\n  1. Condoms, male or female, with or without a spermicide\n  2. Diaphragm or cervical cap with spermicide\n  3. Intrauterine device\n  4. Contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method\n  5. Male partner has previously undergone a vasectomy for which there is documentation of aspermatogenic sterility\n\nEXCLUSION CRITERIA:\n\nIf any of the following exclusion criteria are met, a subject will not be enrolled in this study:\n\n* Absence of a diagnosis of WHIMS\n* Patient is less than 18 years old\n* Absence of a documented history of severe infection\n* Neutropenia due to maturation defects in the myeloid lineage or that the PI feels is unlikely to benefit from this medication\n* Pregnant women or breastfeeding\n* History of serious cardiac arrhythmia or cardiac defects that make such more likely\n* Renal failure (calculated creatinine clearance \\[CrCl\\] \\\u003C15 mL\u002Fmin or requiring dialysis)\n* Signs or symptoms of active microbial infection at the time of study entry.\n* Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study\n* Unwillingness to undergo testing or procedures associated with this protocol","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\n* WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4. Excessive function of this receptor causes mature neutrophils (part of the white blood cells) to be retained within the bone marrow rather than being released to the blood and is one of the causes of severe inherited neutropenia (low white blood counts). In neutropenia, the body is less able to fight off infection. Patients with WHIMS usually are at risk for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing, teeth, and lung function.\n* Current treatment for WHIMS consists of regular injections of a white blood cell growth stimulating medication called granulocyte colony stimulating factor (G-CSF), and supplemental immunoglobulin (antibody). These therapies are expensive, nonspecific, have significant side effects and toxicities, and do not fully correct all problems, especially warts and cancers related to human papillomavirus (HPV).\n* A drug called Mozobil has been approved for use in combination with G-CSF to increase the number of stem cells that can be collected prior to bone marrow transplantation. Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other syndromes characterized by neutropenia.\n\nObjectives:\n\n* To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood cell count) in patients with WHIMS.\n* To determine an appropriate treatment dose of Mozobil, within currently approved dosage levels.\n\nEligibility:\n\n\\- Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a history of severe infections.\n\nDesign:\n\n* Potential participants will undergo a screening with a medical history, physical examination, questionnaire, heart and lung function scans, and blood and urine samples. Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check neutrophil function.\n* Patients who are being treated with G-CSF will stop injections for 2 days before being admitted to the National Institutes of Health (NIH) Clinical Center.\n* Patients may participate in a Dose Escalation study and receive increasing doses of Mozobil over 5 days of treatment until their white blood cell count improves sufficiently or the maximum approved dose is reached. Blood samples will be taken regularly throughout the treatment process. Patients will then receive an additional dose of Mozobil at the maximum approved dose or the dose sufficient to cause improvement, before restarting the G-CSF injections.\n* Patients may also participate in a long-term Chronic Dosing study and receive Mozobil once or twice a day for up to a maximum of 60 months.",[28,29,30,31,32],"Leukopenia","Neutropenia","Infections","Warts","Myelokathexis",[29,34,32,31,35],"Hypogammaglobulinemia","Immunodeficiency","RECRUITING","2026-06-27",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2010-01-06",{"date":44,"type":21},"2026-12-31",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":48},"100616063","comparing-diosmin-hesperidin-and-loratadine-to-prevent-bone-pain-from-g-csf-in-patients-with-blood-cancers-100616063","NCT07300735","Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers","A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies","Inclusion Criteria:\n\n* Adults 18 to 65 years old\n* Receiving a G-CSF for one of the following indications:\n\nTreatment of neutropenia along with treatment for leukemia or lymphoma Neutropenia prevention following autologous hematopoietic cell transplant\n\n* Patients with or without bone pain associated with G-CSF administration.\n* Willingness to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with solid tumors.\n* Pregnant or breastfeeding women.\n* Patients with known allergies or hypersensitivity to Loratadine, Diosmin- Hespiridin or Filgrastim.\n* Patients with pre-existing bone disorders or receiving bone modifying agents\n* Chronic use of antihistamines, Diosmin-Hespiridin, NSAIDs, corticosteroids, or immunosuppressants.\n* Receiving medications with drug interaction grade X with Loratadine, Diosmin-Hespiridin or Filgrastim\n* Patients who are unable to understand or provide informed consent","65 Years",{"count":58,"type":21},88,[60],"NA","This is a comparative interventional study to determine the best way to prevent G-CSF induced bone pain in patients with hematological malignancies (blood cancers). G-CSF (Granulocyte Colony-Stimulating Factor) is a drug commonly used in these patients to boost white blood cell production, but it frequently causes severe bone pain.\n\nThe study is comparing two oral medications for their effectiveness as a preventive treatment:\n\n* Diosmin-Hesperidin (a flavonoid supplement).\n* Loratadine (a common anti-allergy medication).\n\nThe core question the study is trying to answer is:\n\n* Is diosmin-hesperidin effective in preventing G-CSF-induced bone pain compared to loratadine?\n* Does the combination of diosmin-hesperidin and loratadine offer better pain prevention than either drug alone?",[63,29,64],"Hematologic Malignancy","Bone Pain",[66,67,68,69,70,71,72,73,74,75],"Loratadine","Diosmin","Filgrastim","Granulocyte Colony Stimulating Factor","G-CSF Induced Bone Pain","Hesperidin","Flavonoid","Antihistamine","Prophylaxis","Randomized Controlled Trial","2026-06-23",{"date":78,"type":40},"2026-06-24",{"date":80,"type":40},"2025-03-01",{"date":82,"type":21},"2027-07",{"name":84,"class":85},"Alexandria University","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100520417","phase-3-a-study-of-mavorixafor-in-participants-with-congenital-and-acquired-primary-autoimmune-and-idiopathic-chronic-neutropenic-disorders-who-are-experiencing-recurrent-andor-serious-infections-100520417","NCT06056297","A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and\u002For Serious Infections","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and\u002For Serious Infections","Key Inclusion Criteria:\n\n* Diagnosis of congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorder ≥6 months prior to the screening visit that is not attributable to medications, active or recent infections or malignancy.\n* Congenital Neutropenia, including but not limited to these classifications:\n\n  1. Isolated with a permanent (non-cyclic) presentation, for example, elastase, neutrophil expressed (ELANE), colony stimulating factor 3 receptor (CSF3R), C-X-C chemokine receptor 2 (CXCR2), Wiskott-Aldrich syndrome (WAS)\n  2. Associated with extra-hematologic manifestations, for example, Barth syndrome, Cohen syndrome, glucose-6-phosphatase catalytic subunit 3 (G6PC3), Kostmann disease\n  3. Associated with metabolic disorders, for example, glycogen storage disease 1b (GSD1b)\n  4. Shwachman-Diamond syndrome\n* Acquired Primary Neutropenia\n\n  1. Chronic idiopathic neutropenia\n  2. Primary autoimmune neutropenia. Other chronic neutropenia (CN) disorders that may be eligible for enrollment can be clarified and approved upon discussion with study Medical Monitor.\n* Have an ANC \\\u003C1000 cells\u002FµL during screening (single ANC value from hematology) and confirmed trough mean ANC (mean value of multiple ANC measurements over 6 hours) at baseline visit, with no clinical evidence of systemic infection.\n* Prior history of recurrent and\u002For serious infections during the 12 months preceding the screening visit (that is, suffering sequelae of chronic neutropenia), as defined by having at least 2 infections in the last 12 months that meet the following criteria:\n* Infection requiring the use of antibiotics (intravenous \\[IV\\]\u002Foral); OR\n* Infection requiring a visit to healthcare facility (including but not limited to emergency room visit, urgent care facility, primary care physician's office, or in-patient hospitalization);\n\nAND for all potential participants:\n\n* Infections considered by the Investigator to be likely related to the potential participant's CN disorder.\n* Participants who are on G-CSF or other active background therapy must have been receiving these therapies during the previous 12 months while continuing to suffer from infections, be on a stable dose and dosing schedule for ≥4 weeks prior to screening visit and remain on this dose and dosing schedule throughout the study (unless ANC \\>10,000 cells\u002FµL for ≥4 weeks).\n* Participants must be willing to keep their G-CSF or other background therapy doses\u002Fregimens stable (other than for safety reasons) for the duration of the study.\n\nKey Exclusion Criteria:\n\n* A diagnosis of secondary neutropenia including those due to:\n\n  1. Hypersplenism\n  2. Infection\n  3. Malignancy\n  4. Autoimmune disease, for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, graft-versus-host disease, thyroid disease\n  5. Nutritional deficiency, for example, vitamin B12, folic acid, copper, caloric malnutrition\n  6. Drug-induced cause, for example, chemotherapy, clozapine, antiretrovirals, antibiotics, monoclonal antibodies.\n* A diagnosis of any of the following:\n\n  1. Aplastic anemia\n  2. Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome\n  3. Certain CNs, including but not limited to these classifications are excluded:\n\n     1. Isolated with a cyclic presentation, for example, elastase, neutrophil expressed (ELANE)\n     2. Associated with immune dysregulation, for example, common variable immunodeficiency (CVID), autoimmune lymphoproliferative syndrome (ALPS), familial hemophagocytic lymphohistiocytosis, Chédiak-Higashi syndrome, GATA-binding protein 2 (GATA2) deficiency syndrome\n     3. Associated with bone marrow failure, for example, Fanconi anemia, Diamond-Blackfan anemia\n  4. Neutropenia associated with a Duffy-null phenotype (formerly known as benign ethnic neutropenia). However, a participant with an autosomal dominant pathogenic variant in a gene associated with CN on a Duffy-null background may be eligible for inclusion\n* A medical or personal condition that may potentially compromise the safety of the participant, may preclude the participant's successful completion of the clinical study, or could, in the opinion of the Investigator or the Medical Monitor, interfere with the objectives of the study.\n* Received more than 1 dose of mavorixafor in the past.\n* Received C-X-C chemokine receptor 4 (CXCR4) antagonist (other than mavorixafor) in the past 6 months.\n* Participants taking pegylated-G-CSF unless they have a diagnosis of congenital neutropenia confirmed at screening.\n* Participant is currently taking or has taken other investigational drug \\\u003C30 days prior to the screening visit or 5 half-lives, whichever is longer.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","12 Years",{"count":95,"type":21},176,[97],"PHASE3","The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and\u002For serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.",[29],[101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"Mavorixafor","Chronic neutropenia","Chronic idiopathic neutropenia","Severe Congenital Neutropenia (SCN)","C-X-C chemokine receptor 4 (CXCR4)","Congenital and acquired neutropenia","Autoimmune disease","Cohen syndrome","Barth syndrome","ELANE","G6PC3","GSD1b","Kostmann disease","Shwachman-Diamond syndrome","Autoimmune neutropenia (AIN)","2026-06-04",{"date":118,"type":40},"2026-06-05",{"date":120,"type":40},"2024-06-06",{"date":122,"type":21},"2027-11",{"name":124,"class":125},"X4 Pharmaceuticals","INDUSTRY",114,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":48},"100480585","phase-2-prospective-evaluation-of-xerava-prophylaxis-in-hematological-malignancy-patients-with-prolonged-neutropenia-100480585","NCT05537896","Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","Prospective Evaluation of Xerava™ (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","Inclusion Criteria:\n\n* All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT\n* Patient must provide informed consent.\n* Bilirubin ≤ 3 x the ULN and AST\u002FALT ≤ 5 x ULN\n\nExclusion Criteria:\n\n* Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.\n* Urinary tract infection receiving active treatment\n* Acute pancreatitis (not necessary to work-up unless symptomatic)\n* History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline\n* Pseudomonas infection within 30 days prior to study enrollment\n* Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)\n* Pregnant or lactating women",{"count":135,"type":21},55,[25],"Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC\\\u003C100 neutrophils\u002Fmilliliter) for more than seven days. Xerava™ (eravacycline) has a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.",[139,29],"Hematological Malignancy","2026-04-12",{"date":142,"type":40},"2026-04-16",{"date":144,"type":40},"2024-02-19",{"date":146,"type":21},"2028-02",{"name":148,"class":85},"West Virginia University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":48},"100576699","phase-2-luspatercept-for-clonal-cytopenias-of-uncertain-significance-100576699","NCT06788691","Luspatercept for Clonal Cytopenias of Uncertain Significance","Efficacy of Luspatercept In Clonal Cytopenias of Uncertain Significance","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age.\n* Documentation of a CCUS diagnosis.\n\n  * Clonal cytopenia of undetermined significance (CCUS) is defined as clonal hematopoiesis of indeterminate potential (CHIP) detected in the presence of one or more persistent cytopenias that are otherwise unexplained by hematologic or non-hematologic conditions and that do not meet diagnostic criteria for defined myeloid neoplasms. Cytopenia definitions for diagnosis of CCUS include Hb \\\u003C13 g\u002FdL in males and \\\u003C12 g\u002FdL in females for anemia, absolute neutrophil count \\\u003C1.8 ×109\u002FL for leukopenia, and platelets \\\u003C150 × 109\u002FL for thrombocytopenia.\n  * Patients should harbor somatic mutations of myeloid malignancy-associated genes detected in the blood or bone marrow at a variant allele fraction (VAF) of ≥ 2% (≥4% for X-linked gene mutations in males\n* Clinically significant cytopenias demonstrated in two separate lab draws and defined as cytopenia in any one of the following:\n\n  * Anemia: Transfusion dependent (LTD or HTD for Hb \\\u003C 9 g\u002FdL based on IWG 2018 criteria). Exception for higher threshold up to 10g\u002FdL for documented moderate or severe angina pectoris, cardiac or pulmonary insufficiency, or ischemic neurologic diseases (per IWG 2018 consensus recommendation).\n  * Anemia NTD: symptomatic NTD CCUS with Hb \\\u003C10 g\u002Fdl, symptomatic defined as moderate or worse on ≥ 1 Patient Global Impression of Severity (PGI-S) item (fatigue, shortness of breath, weakness, or dizziness)\n  * Thrombocytopenia: platelet count less than 30,000 \u002FmicroL or \\\u003C 50,000\u002FmicroL with documented bleeding events or high risk for bleeding, for example on blood thinners or drugs that inhibit platelet function for other comorbidities.\n  * Neutropenia: Neutropenia below 750\u002Fmicrol are included in the study. For subjects with neutropenia between 750-1000\u002Fmicrol, subjects should have neutropenia AND a history of serious infection(s).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Adequate organ function as defined by:\n\n  * Direct bilirubin \\\u003C 3 x ULN. Indirect hyperbilirubinemia from hemolysis or Gilberts disease are not considered as impaired.\n  * Estimated Creatinine clearance or GFR \\>30 ml\u002Fmin by institutional standards (for example MDRD or Cockcroft Gault or measured by 24 hour urine clearance).\n  * ALT and AST \\\u003C 3 x ULN\n* Females of childbearing potential (FCBP), defined as a sexually mature woman who: 1) has achieved menarche at some point, 2) not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must:\n\n  * Have two negative pregnancy tests (serum or urine) as verified by the investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of W1D1). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.\n  * Either commit to true abstinence1 from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, highly effective contraception2 without interruption, 5 weeks prior to starting investigational product, during the study therapy (including dose interruptions), and for 12 weeks after discontinuation of study therapy.\n\nMale subjects must:\n\n\\- Practice true abstinence1(which must be reviewed prior to each IP administration or on a monthly basis \\[e.g., in the event of dose delays\\]) or agree to use a condom (latex or non-latex, but not made out of natural \\[animal\\] membrane) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 12 weeks following investigational product discontinuation, even if he has undergone a successful vasectomy.\n\nContraception\n\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Highly effective contraception is defined in this protocol as the following (information will also appear in the ICF): Hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (tying your tubes); or a partner with a successful vasectomy.\n\nExclusion Criteria:\n\n* Concurrent malignancy requiring active concurrent systemic chemotherapy. Hormonal therapy for malignancy and targeted radiation is allowed. If patients after enrollment, have a clinical need for chemotherapy after achieving response on treatment, subjects deriving clinical benefit can be continued on study after discussion with study PI.\n* Diagnosis of MDS, AML, MPN or any other myeloid malignancy in the patient's lifetime\n* Active uncontrolled infection that in the investigators opinion will affect study procedures and\u002For results\n* Active uncontrolled hypertension not responding to blood pressure lowering medications which in the investigator's opinion will be harmful for the patient.\n* Use of ESA or growth factors within four weeks prior to the start of the study\n* Known risk factors for thromboembolism (splenectomy, concomitant use of hormone replacement therapy or recent uncontrolled pulmonary embolism or DVT in the last 6 months). Subjects adequately controlled on anticoagulation are permitted.\n* Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment and for up to 130 days after last dose of study drug. Basic contraception methods are defined in Section 4.4.\n\n  * Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks prior to first dose of study drug. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the Informed Consent Form (ICF).",{"count":157,"type":21},50,[25],"The purpose of this clinical trial is to test how well the drug luspatercept works in improving low blood cell counts in people with clonal cytopenias of uncertain significance (CCUS). The main questions the study seeks to answer include:\n\n* How many patients experience improvements in their low blood counts (red cells, platelets, or white cells) within 24 weeks, based on specific criteria for blood conditions like myelodysplastic syndromes (MDS)?\n* How long these improvements last before the condition worsens or changes.\n* The percentage of participants showing improvements at 12, 24, and 48 weeks.\n* How long it takes for the condition to progress to more severe diseases like myeloid disorders.\n* How long red blood cell responses last and how quickly these responses are seen.\n* The average change in hemoglobin levels over 24 weeks.\n* How many patients need blood transfusions during the study and how soon transfusions are required.\n* Changes in participants' well-being and energy levels based on a standardized questionnaire.\n* Monitoring for any side effects, including progression to MDS or leukemia, heart-related issues, or sudden increases in hemoglobin.\n\nParticipants will:\n\n* Receive luspatercept as an injection every three weeks.\n* Visit the clinic every three weeks for treatment and monitoring.",[161,162,28,163,29],"CCUS Clonal Cytopenia of Undetermined Significance","Anemia","Thrombocytopenia","2026-03-20",{"date":166,"type":40},"2026-03-24",{"date":168,"type":40},"2025-03-25",{"date":146,"type":21},{"name":171,"class":85},"Weill Medical College of Cornell University",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100623433","predictive-score-in-patients-with-hematological-malignancies-colonized-by-multidrug-resistant-enterobacteriaceae-100623433","NCT07396571","Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae","Development of a Predictive Infection Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae","SCREEN-IN","Inclusion criteria\n\n* Patients admitted to Hematology departments with hematological diseases, including: myelodysplastic syndrome, acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, chronic myeloproliferative leukemias, lymphomas, or other hematological disorders.\n* Patients scheduled to receive treatment for their underlying hematological disease, including myeloablative\u002Fcytotoxic chemotherapy, conditioning chemotherapy for hematopoietic stem cell transplantation (autologous, allogeneic, or other types), lymphodepleting chemotherapy for CAR-T cell therapy, and\u002For other treatments expected to induce neutropenia.\n* Patients expected to develop neutropenia (neutrophil count \\\u003C 0.5 \\\\times 10\\^9\u002FL, or \\\u003C 1.0 \\\\times 10\\^9\u002FL when predicted to fall below 0.5 \\\\times 10\\^9\u002FL within the next 48 hours) in the coming days.\n* Those who have signed the informed consent form.\n* Participation in another study is permitted, provided it is observational and does not influence the potential colonization status.\n\nExclusion criteria\n\n* Psychiatric disorder or inability to understand or follow the protocol instructions.\n* Terminally ill patients or those with an estimated life expectancy of less than 30 days.\n* Previous enrollment in the study.\n* Known prior colonization by ESBL-producing Enterobacteriaceae (ESBL-E) or carbapenemase-producing Enterobacteriaceae (CPE).\n* Physician's discretion: The patient's attending physician prefers not to include the patient in the study.",{"count":181,"type":21},535,"OBSERVATIONAL","The goals of this observational study are to identify risk factors for ESBL-producing Enterobacterales and carbapenemase-producing Enterobacterales (CPE) colonization in oncohematological patients with severe neutropenia, and to develop and validate a predictive model of infection caused by ESBL-producing Enterobacterales and CPE in patients previously colonized by the same bacteria.\n\nThe main questions the study aims to answer are:\n\n* What are the risk factors for ESBL-producing Enterobacterales and CPE colonization in patients with severe neutropenia?\n* Can a predictive model be developed to accurately predict infections in the colonized patients?\n\nStudy Design \\& Participants: Participants will be screened after receiving neutropenia-inducing treatment (e.g., chemotherapy, chimeric antigen receptor T-cell (CAR-T) therapy, or others). A baseline rectal swab will be collected to assess initial colonization status, followed by weekly swabs throughout the duration of neutropenia. Patients will be followed for 90 days from initial screening, during which the study team will record any infections, with an additional 30-day follow-up period. All hospitalization data will be recorded.",[185,186,29,187,188],"Hemato-oncologic Patients","Colonization","Enterobacteria Non Susceptible to Carbapenem Carrier","ESBL-producing Enterobacteriaceae Infections","NOT_YET_RECRUITING","2026-02-27",{"date":192,"type":40},"2026-03-02",{"date":194,"type":21},"2026-02",{"date":196,"type":21},"2028-12",{"name":198,"class":85},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",15,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":208,"studyType":182,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":48},"100626317","real-world-study-on-the-prevention-of-neutropenia-after-tumor-treatment-with-mecapegfilgrastim-injection-100626317","NCT07434063","Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection","Inclusion Criteria:\n\n* 1\\. Patients with malignant tumors confirmed by histopathology or cytology; 2. Age ≥18 years old; 3. After referring to various guidelines, the researchers believed that the subjects:\n\n  1. Patients who are currently receiving treatment regimens with high FN risk;\n  2. Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;\n  3. FN or dose-limiting neutropenia events have occurred in previous treatment cycles;\n  4. In addition to the above, the researchers believe that the medication regimens will cause neutropenia and affect the normal treatment of the subjects; 4. Researchers believe that they can benefit; 5. Voluntarily participate in this clinical trial and be able to sign the informed consent form in person.\n\nExclusion Criteria:\n\n* 1\\. Those who are allergic to the test drug； 2. Those with mental or neurological disorders who are unable to cooperate； 3. Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures； 4. Those who were considered unsuitable for inclusion by the researchers.",{"count":207,"type":21},200,"42 Days","This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy\u002Fchemotherapy\u002Fimmunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy\u002Fchemotherapy\u002Fimmunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary\u002Fsecondary prevention after receiving tumor treatment.",[29],"2026-02-24",{"date":213,"type":40},"2026-02-25",{"date":215,"type":40},"2025-06-18",{"date":217,"type":21},"2027-06-30",{"name":219,"class":85},"Hebei Medical University Fourth Hospital",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":226,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":48},"100598022","early-phase-1-serial-blood-count-study-100598022","NCT07066085","Serial Blood Count Study","Inclusion Criteria:\n\n* Confirmed diagnosis of severe chronic neutropenia\n* 5 years of age or older, male or female\n* Known positive ELANE mutation\n* Computer if available\n* Internet access\n* Cell phone \u002F Smart phone that can download \u002F install applications (App)\n* Adults that are comfortable obtaining the samples without medical conditions that would make collection of the sample difficult.\n\nExclusion Criteria:\n\n* Diagnosis of severe chronic neutropenia and negative results for the ELANE mutation\n* Less than 5 years of age\n* No internet access\n* No Cell phone or smart phone that cannot download \u002F install applications (App)\n* Adults that are uncomfortable obtaining the samples or have medical conditions that would make collection of the sample difficult.","5 Years",{"count":20,"type":21},[229],"EARLY_PHASE1","The objective of the Serial Blood Count Study is to determine the utility of home monitoring of white blood cell (WBC) and absolute neutrophil counts (ANC) to diagnose cyclic neutropenia and distinguish between cyclic and severe congenital neutropenia (SCN). A new home monitoring device called Athelas One was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC). The investigators believe this device provides a unique and extremely valuable opportunity to for diagnosis of these diseases.",[232,233,29],"Cyclic Neutropenia","Congenital Neutropenia",[29,232,233,235],"Device","2025-07-03",{"date":238,"type":40},"2025-07-15",{"date":240,"type":40},"2024-10-17",{"date":242,"type":21},"2025-12-01",{"name":244,"class":85},"University of Washington",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":270,"locationsCount":48},"100596583","prospective-study-evaluate-the-timing-of-empirical-treatment-for-carbapenem-resistant-bacterials-croeat-study-100596583","NCT07047352","Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)","A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)","Inclusion Criteria:\n\n* Patients with hematological malignancies receiving hospital treatment such as chemotherapy\u002Fimmunotherapy\u002Fhematopoietic stem cell transplantation;\n* Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;\n* Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:\n\n  1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\\>20% among recently hospitalized patients);\n  2. Presence of fever or other possible signs and symptoms of infection;\n  3. Neutropenia(ANC\\\u003C0.1×10\\^9\u002FL)expected to last for ≥7 days,and having any of the following:\n\n     * Gastrointestinal mucositis\u002Fperi-anal infection\u002Fintestinal obstruction;\n\n       * Shock or severe sepsis;\n\n         * Respiratory failure:deoxygenated PaO2\\\u003C60 mmHg or requiring mechanical ventilation;\n\n           * Disseminated intravascular coagulation;\n\n             * Altered mental status or psychiatric abnormalities;\n\n               * Congestive heart failure requiring treatment;\n\n                 * Arrhythmia requiring treatment;\n\n                   * Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).\n* The patient or their legal guardian has signed the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;\n* Any conditions that the investigator believes may increase the risk to the patient;\n* Severe psychological or psychiatric disorders with poor estimated compliance;\n* The presence of any other conditions that the investigator deems unsuitable for participation in this study.",{"count":253,"type":21},91,[60],"In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:\n\n1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\\>20% among recently hospitalized patients);\n2. Presence of fever or other possible signs and symptoms of infection;\n3. Neutropenia(ANC\\\u003C0.1×10\\^9\u002FL)expected to last for ≥7 days,and having any of the following:\n\n   * Gastrointestinal mucositis\u002Fperi-anal infection\u002Fintestinal obstruction;\n\n     * Shock or severe sepsis;\n\n       * Respiratory failure:deoxygenated PaO2\\\u003C60 mmHg or requiring mechanical ventilation;\n\n         * Disseminated intravascular coagulation;\n\n           * Altered mental status or psychiatric abnormalities;\n\n             * Congestive heart failure requiring treatment;\n\n               * Arrhythmia requiring treatment;\n\n                 * Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).\n\nThe endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.",[257,29,258],"Carbapenem-resistant Enterobacterales","Hematological Malignancies",[260,261,262,263],"carbapenem-resistant enterobacterales","hematological malignancies","neutropenia","empirical therapy","2025-06-24",{"date":266,"type":40},"2025-07-02",{"date":268,"type":21},"2025-08-01",{"date":39,"type":21},{"name":271,"class":85},"Shanghai Jiao Tong University School of Medicine",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100594348","a-study-on-the-use-of-sulpegfilgrastim-to-prevent-the-incidence-of-neutropenia-with-infection-in-newly-diagnosed-non-transplant-multiple-myeloma-patients-100594348","NCT07018271","A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients","Inclusion Criteria:\n\nPatients must meet all the following criteria to be eligible for this study:\n\n1. Age ≥ 18 years old，weight \\> 35 kg，regardless of gender;\n2. Voluntarily participating in the study after signing the informed consent form;\n3. Newly diagnosed, non-transplanted multiple myeloma patients diagnosed according to the 2016 International Myeloma Working Group (IMWG) criteria or the 2024 Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma, and expected to receive at least six cycles of DRD (CD38 monoclonal antibody + lenalidomide + dexamethasone) oncological treatment;\n4. Deemed suitable for sulpegfilgrastim administration by the investigator;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2, with an expected survival of at least three months;\n6. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count (PLT) ≥ 75.0×10⁹\u002FL；\n7. Serum creatinine clearance rate ≥30 mL\u002Fmin; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤three times the upper limit of normal。\n8. Negative pregnancy test for women of childbearing age. Patients and their spouses must agree to use effective contraceptive measures during treatment and for one year thereafter；\n9. Signed informed consent for chemotherapy. In cases where the patient is unable to sign due to impaired consciousness, upper limb paralysis, or illiteracy, a legal representative may sign on their behalf.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are excluded from this study：\n\n1. Weight≤35kg；\n2. Monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, or primary light chain amyloidosis with organ involvement;\n3. Diagnosed or treated for another malignancy within one year prior to registration, or evidence of residual disease from a previous malignancy requiring ongoing treatment;\n4. Known positive for human immunodeficiency virus (HIV);\n5. Pregnant or breastfeeding women;\n6. Patients with any active acute infection, including viral infections;\n7. Patients who have received systemic antibiotic treatment within two weeks prior to enrollment;\n8. Allergy to Sulfubrolipoyl G-CSF, pegylated recombinant human granulocyte colony-stimulating factor, recombinant human granulocyte colony-stimulating factor, or other agents expressed in E. coli; Other situations where the investigator deems participation in the study inappropriate.",{"count":279,"type":21},24,[60],"The goal of this study is to observe and evaluate the incidence of infection in newly diagnosed, non-transplanted multiple myeloma patients receiving prophylactic treatment with sulpegfilgrastim (a pegylated recombinant human granulocyte colony-stimulating factor).",[283,284,285,29],"Multiple Myeloma","DRD","Sulpegfilgrastim","2025-06-04",{"date":288,"type":40},"2025-06-12",{"date":290,"type":21},"2025-06-30",{"date":292,"type":21},"2026-12-30",{"name":294,"class":85},"The First Affiliated Hospital of Soochow University",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":48},"100557408","breath-analysis-for-the-detection-of-invasive-fungal-infections-100557408","NCT06537726","Breath Analysis for the Detection of Invasive Fungal Infections","Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients","REDEFINE","Inclusion Criteria:\n\n* Diagnosis of acute leukemia\n* Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer\n* Neutropenia (\\\u003C500\u002Fµl) present at inclusion or planned chemotherapy with expected neutropenia (\\\u003C500\u002Fµl) for more than 7 days\n\nExclusion Criteria:\n\n* Unable to follow instructions for breath analysis\n* Anatomic abnormalities precluding the use of a mouthpiece for breath analysis",{"count":304,"type":21},130,"Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.\n\nWith the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).",[307,308,309,29,310,311,312],"Leukemia","Leukemia, Myeloid","Leukemia, Lymphoblastic","Chemotherapy-induced Neutropenia","Invasive Fungal Infections","Invasive Pulmonary Aspergillosis","2025-04-09",{"date":315,"type":40},"2025-04-10",{"date":317,"type":40},"2024-08-19",{"date":319,"type":21},"2027-10-31",{"name":321,"class":85},"University of Zurich",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":333,"conditions":334,"keywords":338,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":48},"100487395","phase-4-letermovir-for-secondary-prophylaxis-in-solid-organ-transplant-recipients-100487395","NCT05626530","Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients","A Pilot Trial of the Tolerability and Clinical Effectiveness of Letermovir When Used for Secondary Prophylaxis to Prevent Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients","Inclusion Criteria:\n\n1. Adult (\\> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician deems that the patient need secondary prophylaxis and in whom written informed consent is obtained.\n2. Patient able to participate with follow up for 6 months\n3. Not enrolled in competing clinical trials\n\nExclusion Criteria:\n\n1. Patients with creatinine clearance less than 10 ml per min at time of enrollment\n2. Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing\n3. On CVVH or renal dialysis at the time of enrollment\n4. Has Child Pugh Class C severe hepatic insufficiency at screening.\n5. Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency at screening.\n\n   Note: Moderate hepatic insufficiency is defined as Child Pugh Class B (Appendix 8); moderate to severe renal insufficiency is defined as CrCl \\\u003C50 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n6. Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.\n7. Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.\n8. Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.\n9. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.\n10. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the 6 months) of drug or alcohol abuse or dependence.\n\n    Note: Participants with a history of marijuana use which is not deemed excessive by an investigator or does not interfere with the participant's daily function may participate in the study.\n11. Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with an investigational monoclonal antibody will be eligible to participate after a 150-day washout period.\n12. Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent that is not approved or is planning to participate in a study of a CMV vaccine or another unapproved CMV investigational agent during the course of this study.\n\n    \\-",{"count":330,"type":21},25,[332],"PHASE4","This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient.\n\nThis study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.",[335,336,29,337],"Cytomegalovirus Infections","Infection in Solid Organ Transplant Recipients","Antiviral Toxicity",[339,340,341,342,262],"Cytomegalovirus infection","Letermovir","Secondary prophylaxis","T cell immunity","2025-04-07",{"date":315,"type":40},{"date":346,"type":40},"2023-02-02",{"date":348,"type":21},"2025-12-15",{"name":350,"class":85},"Tufts Medical Center",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":357,"maxAge":358,"enrollmentInfo":359,"targetDuration":361,"studyType":182,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":48},"100586332","the-prevalence-and-impacts-of-nudix-hydrolase-15-nudt15-gene-variants-in-taiwanese-inflammatory-bowel-disease-100586332","NCT06913998","The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Participants who are diagnosed with inflammatory bowel disease.\n\nExclusion Criteria:\n\n* Participants who refused to have blood test for NUDT15 gene evaluation.","1 Year","25 Years",{"count":360,"type":21},65,"2 Years","The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.",[364,29,365],"Inflammatory Bowel Diseases","Nudt15 Deficiency","2025-04-06",{"date":368,"type":40},"2025-04-08",{"date":370,"type":40},"2023-12-27",{"date":372,"type":21},"2026-11",{"name":374,"class":85},"National Taiwan University Hospital",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":48},"100534970","phase-1-ucmsc-exo-for-chemotherapy-induced-myelosuppression-in-acute-myeloid-leukemia-100534970","NCT06245746","UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia","A Single-center, Prospective Trial of the Safety and Efficacy of UCMSC-Exo in Consolidation Chemotherapy-induced Myelosuppression in Patients With Acute Myeloid Leukemia After Achieving Complete Remission","Inclusion Criteria:\n\n1. Aged between 18 and 60 years old;\n2. Acute myeloid leukemia (AML, AML subtype M3 excluded) diagnosed according to the 2022 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, who have achieved complete remission (CR1) and are going to receive consolidation therapy (cytarabine or cytarabine-based combined regimen, the cycle of consolidation therapy is not limited);\n3. The participant or his\u002Fher legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent;\n4. Male or female;\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated)\n6. Estimated survival of at least 3 months;\n7. Adequate major organ function:\n\n   1. Respiratory function: indoor oxygen saturation of at least 95%;\n   2. Cardiac function: ejection fraction of left ventricular of at least 45%;\n   3. Hepatic function: alanine aminotransferase\u002Faspartate aminotransferase of at most 2.5 times\u002Fupper limit of normal value and serum total bilirubin of at most 1.5 times\u002Fupper limit of normal value;\n   4. Renal function: Serum creatinine of at most 1.5 times\u002Fupper limit of normal value;\n8. Participants who do not receive any type of anti-cancer therapy within 2 weeks before enrollment (radiation therapy, chemotherapy and\u002For immune therapy, et al.), and treatment-associated toxicities induced by previous therapy has recovered to Grade 1 or below (except for low grade toxicities such as alopecia).\n9. For female participants, they should be surgical sterilized or post-menopausal, or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; For male participants, they should be surgical sterilized or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study;\n\nExclusion Criteria:\n\n1. Central nervous system manifestations of acute myeloid leukemia at diagnosis;\n2. Secondary acute myeloid leukemia;\n3. Myelosuppression induced by conditions other than anti-cancer therapy;\n4. Previous radiation therapy performed on sternum or pelvis;\n5. Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection without improvement despite anti-infective agents) ;\n6. Uncontrolled active bleeding at enrollment;\n7. Severe underlying comorbidities affecting survival, including cachexia, severe malnutrition, etc;\n8. Estimated survival of at most 48 hours;\n9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;\n10. History of or current human immunodeficiency virus (HIV) infection;\n11. Syphilis infection;\n12. Continuous usage of immunosuppressants or received organ transplantation in the last 6 months;\n13. Participation in clinical trials of other drugs within 6 weeks before enrollment;\n14. Previous participation in clinical stem cell or exosome research;\n15. Receive any agent concurrently with UCMSC-Exo infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ;\n16. Severe allergic constitution, or known or suspected allergy to the study drug and its components;\n17. Known contraindication to receiving hematopoietic growth factors, transfusion of blood components, anti-infective agents;\n18. Female participants who are pregnant or breast feeding;\n19. Participants suffering from mental illness;\n20. Presence of drug abuse\u002Faddiction;\n21. History of other malignancies other than hematological malignancies within 3 years;\n22. Participants without signed informed consent;\n23. Participants with poor compliance and are unable to complete the whole course of the study;\n24. Participants with circumstances that, in the opinion of the investigator, may increase the risk of the participants or interfere with conduct of the clinical trial and the judgment of results (excessive tension, sensitivity or cognitive impairment, etc) ;\n25. Participants with other circumstances that are ineligible for enrollment in this study, in the opinion of the investigator.","60 Years",{"count":384,"type":21},9,[24],"The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.",[388,29,162,163,30,389],"Acute Myeloid Leukemia","Bleeding",[391,392,262,393,394,395,396,397,398],"umbilical cord derived mesenchymal stem cells exosomes","chemotherapy-induced myelosuppression","anemia","thrombocytopenia","infections","bleeding","acute myeloid leukemia","chemotherapy","2025-03-20",{"date":401,"type":40},"2025-03-21",{"date":403,"type":40},"2025-02-26",{"date":405,"type":21},"2027-02",{"name":407,"class":85},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":415,"sex":16,"minAge":17,"maxAge":382,"enrollmentInfo":416,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":418,"conditions":419,"keywords":422,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":4},"100553839","effects-of-levetiracetam-monotherapy-on-various-hematological-parameters-in-adult-patients-suffering-of-epilepsy-100553839","NCT06491303","Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy","Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy","Inclusion Criteria: Adult Epileptic patients of both genders aged \\>18 years on mono-therapy of levetiracetam anti-epileptic drug treatment for at least six months.\n\nExclusion Criteria:\n\n1. Patients were on treatment for less than six months.\n2. Patients had other conditions besides epilepsy that could affect blood parameters.\n3. patients on treatment with other antiepileptic medications besides levetiracetam.",true,{"count":417,"type":21},45,"Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs. The conventional antiepileptics like phenytoin, phenobarbitone, valproate and carbamazepine and newer antiepileptics like levetiracetam. are used for epilepsy. AEDs induce potentially toxic effects over a period of time which remains undetermined over very long time. Earlier studies in this regard, states uneven results about hematological (Hb%, blood cell count etc.) toxicity of AEDs.",[29,163,420,162,421],"Aplastic Anemia","Epilepsy",[423,424,425,421,29,163],"Levetiracetam","Hematological effects","antiepileptic drugs","2024-06-30",{"date":428,"type":40},"2024-07-09",{"date":430,"type":21},"2024-11-01",{"date":242,"type":21},{"name":433,"class":85},"Assiut University",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":48},"100548556","ceftolozanetazobactam-vs-piperacillintazobactam-for-the-treatment-of-bacteremia-in-hemato-oncological-patients-100548556","NCT06422533","Ceftolozane\u002FTazobactam vs. Piperacillin\u002FTazobactam for the Treatment of Bacteremia in Hemato-oncological Patients","Ceftolozane\u002FTazobactam vs. Piperacillin\u002FTazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study","Inclusion Criteria:\n\n* All patients \\>18 years old\n* Diagnosis of any hematological malignancy\n* Severe neutropenia (polymorphonuclear \\\u003C500 cells\u002Fmm3)\n* Fever (≥38.3 degrees Celsius in one measure, or ≥38 degrees Celsius in at least two measures)\n* Median arterial pressure ≥65 mmHg on admission\n* A life expectancy ≥ 5 days\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Known hypersensitivity to cephalosporins or anaphylaxis with beta-lactams\n* Clinical signs related to hemodynamic instability\n* Concomitant use of another antibiotic with activity against Gram-negatives (except Trimethoprim\u002FSulfamethoxazole (TMP\u002FSMX) as prophylaxis for P. jirovecii\n* Patients with end-stage chronic renal failure (\\\u003C10 ml\u002Fmin by creatinine clearance-ACCr) or on renal replacement therapy.\n* Patients with grade IV mucositis",{"count":442,"type":21},226,[60],"Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia.\n\nAt a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane\u002Ftazobactam (C\u002FT) as a \"carbapenem-sparing\" antibiotic has been proposed.\n\nC\u002FT has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens.\n\nAt the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin\u002Ftazobactam (P\u002FT). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P\u002FT-resistant bacteria are identified, this is escalated to carbapenem.\n\nTherefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C\u002FT vs. P\u002FT, trying to reduce the use of carbapenems in this group of patients.",[446,29],"Hematologic Neoplasms",[448,449,262,450],"ceftolozane\u002Ftazobactam","piperacillin\u002Ftazobactam","hematologic neoplasms","2024-06-02",{"date":453,"type":40},"2024-06-04",{"date":455,"type":40},"2023-11-07",{"date":457,"type":21},"2025-08-30",{"name":459,"class":85},"Instituto Nacional de Cancerologia de Mexico",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":415,"sex":16,"minAge":357,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":48},"100195543","cologne-cohort-of-neutropenic-patients-coconut-100195543","NCT01821456","Cologne Cohort of Neutropenic Patients (CoCoNut)","The Cologne Cohort of Neutropenic Patients (CoCoNut) - a Non-interventional Cohort Study Assessing Risk Factors, Interventions, and Outcome of Immunosuppressed Patients With or Without Opportunistic Infections","CoCoNut","Inclusion Criteria:\n\n* immunosuppressed patients\n\nExclusion Criteria:\n\n* none",{"count":469,"type":21},100000,"The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.",[258,472,473,29,474],"Cancer","Chemotherapy","Immunosuppression",[261,476,398,477,478,479],"cancer","anti-infectives","treatment","outcome","2013-03-26",{"date":482,"type":21},"2013-04-01",{"date":484,"type":4},"1995-01",{"date":486,"type":21},"2050-12",{"name":488,"class":85},"University Hospital of Cologne"]