[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agvhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agvhd":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100585601","phase-2-co-transplant-of-an-unmodified-haplo-identical-graft-with-cord-blood-100585601",false,"NCT06904482","Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood","Inclusion Criteria:\n\n* Participants with the following hematologic malignancies:\n\n  * Acute myelogenous leukemia (AML): High-risk AML including:\n\n    * Antecedent hematological disease (e.g., myelodysplasia (MDS))\n    * Treatment-related\n    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)\n    * Participants must be in CR1, CR2, CR3 or CRi\n  * Acute lymphoblastic leukemia (ALL)\n\n    * High-risk CR1 including:\n\n      * Poor-risk cytogenetics (e.g., t(9;22)or 11q23 rearrangements)\n      * Presence of minimal disease by flow cytometry or PCR or Clonoseq after 2 or more cycles of chemotherapy\n      * No CR within 4 weeks of initial treatment\n    * Participants in CR2 or beyond\n    * Participants must be in CR1, CR2, CR3, or CRi\n  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R) or treatment related MDS\n  * High-risk lymphoma\n* Age \\> 18 years\n* Participants without a suitable HLA-matched related or unrelated donor CASE9Z24 Page 17 Version dated 12.16.2025\n* Participants with the following suitable grafts:\n\n  * A 4-8\u002F8 HLA high resolution matched cord blood unit with a cell dose of 1.0x105 CD34 cells\u002Fkg.\n  * A haplo-identical donor with a goal cell dose of \\> 4.0x106 CD34cells\u002Fkg (minimum 2 x106 CD34 cells\u002Fkg)\n* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia including standard intrathecal chemotherapy and\u002For radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Participants must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with inadequate Organ Function as defined by:\n\n  * Creatinine clearance \\\u003C 40ml\u002Fmin (Cockcroft-Gault)\n  * Bilirubin \\> 2X institutional upper limit of normal unless Gilbert syndrome\n  * AST (SGOT) \\> 3X institutional upper limit of normal\n  * ALT (SGPT) \\> 3X institutional upper limit of normal\n  * Pulmonary function: DLCOc \\\u003C 60%\n  * Cardiac: left ventricular ejection fraction \\\u003C 40%\n  * ECOG \\\u003C2\n* Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.\n* Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.","ALL","18 Years",{"count":18,"type":19},36,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.",[25,26,27,28],"aGVHD","Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Myelodysplastic Syndromes",[30,31],"Unmodified Haplo-Identical Graft with Cord Blood","post-transplant cyclophosphamide aGVHD prophylaxis","RECRUITING","2026-02-25",{"date":35,"type":36},"2026-02-27","ACTUAL",{"date":38,"type":36},"2025-08-13",{"date":40,"type":19},"2030-02-25",{"name":42,"class":43},"Case Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100622245","phase-1-a-clinical-study-on-the-efficacy-and-safety-of-ivarmacitinib-in-preventing-agvhd-after-hla-matched-transplantation-100622245","NCT07381114","A Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing aGVHD After HLA-matched Transplantation","Phase II Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing Acute Graft-versus-host Disease After HLA-matched Transplantation","Ivarmacitinib","Inclusion Criteria:\n\n* The patients have been clearly diagnosed with hematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. The planned treatment for these patients is myeloablative or reduced-intensity conditioning, followed by HLA half-matched stem cell transplantation.\n* Has not received any systemic treatment, including extracorporeal photodynamic therapy (ECP)\n* KPS\\>60% or ECOG PS 0-2\n* Patients who have not received any other prophylactic immunosuppressive agents or aGVHD\u002FcGVHD treatment are eligible\n* The female subjects of childbearing age are willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study period and within 180 days after the last administration of the study drug; for male subjects whose partners are of childbearing age, they agree to use an effective contraceptive method during the study period and within 180 days after the last administration of the study drug\n\nExclusion Criteria:\n\n* Pregnant women or women who are breastfeeding\n* Absolute Neutrophil Count (ANC) \\\u003C 1.0 x 109\u002FL or Platelet Count \\\u003C 50 x 109\u002FL\n* Uncontrolled active infections or active hepatitis B or hepatitis that requires antiviral treatment\n* Human Immunodeficiency Virus (HIV) positive\n* Uncontrolled concurrent diseases, including but not limited to persistent or active infections, autoimmune diseases, thrombosis, symptomatic congestive heart failure, unstable angina pectoris, unstable arrhythmias, or mental disorders\u002Fsituations that would limit compliance with the study requirements\n* There are severe respiratory system diseases, severe renal function impairment, clinically significant or uncontrolled heart diseases, unresolved cholestasis and liver diseases (not attributable to aGvHD). Diseases that interfere with coagulation or platelet function and\u002For current drug treatments\n* Immunosuppressive doses of steroids. This does not exclude the use of steroids in subjects with adrenal cortical insufficiency\n* The diagnosis was clear: chronic lymphocytic leukemia, marginal zone lymphoma (MALT type), smoldering multiple myeloma, etc., all being low-grade malignant\u002Fcancer-preventing blood tumors\n* Patients who have been diagnosed with pre-transplantation digestive tract perforation and have a history of gastric or intestinal resection surgeries, etc., may have their drug absorption affected\n* It is known that there may be allergic reactions, hypersensitivity reactions or intolerance to the studied drug or its excipients\n* The researchers believe that there are any conditions that might harm the subjects or prevent them from fulfilling or meeting the requirements of the study","70 Years",{"count":55,"type":19},32,[57,22],"PHASE1","To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.",[25],[51,25],"NOT_YET_RECRUITING","2026-01-23",{"date":64,"type":36},"2026-02-02",{"date":66,"type":19},"2026-02-14",{"date":68,"type":19},"2027-12-30",{"name":70,"class":43},"Institute of Hematology & Blood Diseases Hospital, China",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":44},"100611857","phase-2-bpc2001-for-the-prevention-of-acute-graft-versus-host-disease-following-haploidentical-stem-cell-transplantation-100611857","NCT07246031","BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation","An Open-Label, Single-Arm, Phase Ⅱb Clinical Study of BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation","Inclusion Criteria:\n\n1. Male or female ages ≥18 and ≤ 65 years.\n2. Before the start of the trial, the subject or his\u002Fher guardian is sufficient to understand and voluntarily sign the written informed consent form (ICF).\n3. Subjects have a hematologic malignancy as defined below and are considered candidates for haplo-SCT:\n\n   1. Acute leukemia with morphologic complete remission (acute myelogenous leukemia \\[AML\\] or acute lymphoblastic leukemia \\[ALL\\]);\n   2. Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN) with \\\u003C 10% blasts in the bone marrow.\n4. Organ function tolerated for transplantation:\n\n   1. Cardiac function: Left ventricular ejection fraction at rest ≥ 45%;\n   2. Liver function: Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 × ULN. Subjects who have been diagnosed with Gilbert's syndrome or malignant disease involvement are allowed to have a total bilirubin value \\> 1.5 × ULN;\n   3. Serum creatine \\\u003C 2 mg\u002FdL or estimated creatinine clearance \\> 50 mL\u002Fmin calculated using the Cockcroft-Gault equation；\n   4. Pulmonary function tests (PFTs): diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) and\u002For forced expiratory volume in 1 second (FEV1) ≥ 50%.\n5. Subject is suitable for myeloablative haplotype related donor transplant.\n6. Subject is suitable for receiving first alloHSCT.\n7. The transplant donor must meet the following criteria:\n\n   1. Donor ages \\> 30 years; If the donor ages is equal to or less than 30 years, the donor should be female for male subject;\n   2. High-resolution typing of human leukocyte antigen (HLA)-A, -B, -C, DR, and DQ are matched at least 5\u002F10;\n   3. Meet the criteria for peripheral blood stem cell (PBSC) donation;\n   4. Donor's specific antibodies are negative, \\\u003C2,000 MFI.\n8. Source of allografts: using G-CSF as the mobilizing agent to mobilize PBSC transplant; bone marrow or cord blood is not allowed.\n9. Karnofsky Performance Status (KPS) score ≥ 60 points.\n10. Is a Candidate for anti-GvHD prophylaxis, including ATG, calcineurin inhibitor (CsA or tacrolimus \\[FK 506\\]) in combination with MTX and MMF.\n11. Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.\n12. Male subjects must agree to use effective contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.\n\nExclusion Criteria:\n\nAny subjects who meet any of the following criteria will be excluded from study entry:\n\n1. Has had any other prior organ transplantation.\n2. Planned use of any additional or alternative drugs for GvHD prophylaxis than listed in the inclusion criteria.\n3. Has had received an investigational drug within 4 half-lives or within 14 days prior to HSCT, whichever is longer; or plans to participate in another clinical study prior to completion of all scheduled evaluations in this clinical study.\n4. Has other malignancies that are not controlled.\n5. Has evidence of active central nervous system (CNS) disease.\n6. Patients with uncontrolled active bacterial, viral, or fungal infections.\n7. Known history of human immunodeficiency virus (HIV) or positive HIV antibody test.\n8. Hepatitis B virus surface antigen (HBsAg) or hepatitis B virus core antibody (HBcAb) is positive, and the hepatitis B virus (HBV) DNA in peripheral blood is above the limit of quantification; or hepatitis C virus (HCV) antibody and peripheral HCV RNA are positive; or the syphilis TRUST test is positive.\n9. Pregnant or lactating females.\n10. Has undergone major surgery within 1 month prior to the first dose of investigational drug.\n11. In the opinion of the investigator, the subject has any other medical condition that renders the subject unsuitable for participation in the study.\n12. Has a history of uncontrolled autoimmune disease or on active treatment.\n13. Vaccinated with live or attenuated vaccine within 4 weeks prior to the first dose of investigational drug.\n14. History of myocardial infarction, unstable angina, acute coronary syndrome, congestive heart failure (New York Heart Society classification ≥ class Ⅲ), or clinically significant arrhythmia within 6 months prior to receiving the investigational drug.\n15. Plan to use prophylaxis donor lymphocyte infusion (DLI) therapy.\n16. The transplant donor is the subject's mother or collateral relative.","65 Years",{"count":80,"type":19},50,[22],"A Phase IIb open label study evaluates the safety and efficacy of repeat doses of BPC2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Haploidentical Stem Cell Transplantation (Haplo-SCT).",[84,25,85,86],"Graft -Versus-host-disease","Haploidentical Stem Cell Transplantation","cGVHD",[88,89,90,91,92],"aGvHD","Haplo-SCT","BPC2001","BioPhoenix","KRN-7000","2025-11-20",{"date":95,"type":36},"2025-11-24",{"date":97,"type":36},"2025-10-29",{"date":99,"type":19},"2028-02-28",{"name":101,"class":102},"BioPhoenix Co., Ltd.","INDUSTRY",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100607213","phase-2-study-of-gecacitinib-corticosteroid-as-first-line-therapy-for-grade-ii-iv-acute-graft-versus-host-disease-100607213","NCT07185633","Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease","A Prospective, Single-Arm, Phase II Clinical Study of Gecacitinib-Corticosteroids as First-Line Treatment for Grade II-IV Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 1\\. Voluntarily sign informed consent form (ICF); age ≥18 years at ICF signing.\n* 2\\. Recipients who underwent non-myeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow or peripheral blood stem cells.\n* 3\\. Have received systemic corticosteroid therapy for no more than 2 days (48 hours).\n* 4\\. Documented myeloid and platelet engraftment: Absolute Neutrophil Count (ANC) \\>0.5 × 10⁹\u002FL for 3 consecutive days, platelet count \\>20 × 10⁹\u002FL for 7 consecutive days without transfusion support (use of growth factors, transfusion support allowed).\n* 5\\. Clinical diagnosis of Grade II-IV aGVHD according to the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria.\n* 6\\. ECOG performance status 0-2.\n* 7\\. Life expectancy greater than 4 weeks.\n* 8\\. Able to swallow tablets.\n* 9\\. Capable of complying with study and follow-up procedures.\n\nExclusion Criteria:\n\n* 1\\. Having undergone ≥2 allo-HSCT procedures.\n* 2\\. SR-aGVHD occurring after unplanned donor lymphocyte infusion (DLI) used for prophylactic treatment of malignancy relapse. \\*Note: Patients receiving planned DLI as part of the transplant procedure, not intended for managing malignancy relapse, may be included.\\*\n* 3\\. Concurrent treatment with other JAK inhibitors.\n* 4\\. Presence of active bleeding.\n* 5\\. Diagnosed or suspected chronic GVHD.\n* 6\\. Presence of uncontrolled active infection. Uncontrolled active infection is defined as: hemodynamic instability due to sepsis, or worsening of symptoms, signs, or radiographic findings due to infection. Persistent fever without symptoms or with stable symptoms is not considered an uncontrolled active infection.\n* 7\\. Presence of unresolved toxicity or complications due to allo-HSCT (excluding aGVHD).\n* 8\\. Any significant clinical or laboratory abnormality that may affect safety evaluation, such as:\n\n  1. Uncontrolled diabetes (fasting blood glucose \\>13.9 mmol\u002FL);\n  2. Hypertension that cannot be controlled to within SBP \\\u003C160 mmHg and DBP \\\u003C100 mmHg with two or more antihypertensive agents;\n  3. Peripheral neuropathy (NCI-CTCAE v5.0 Grade 2 or higher).\n* 9\\. History of NYHA Class III or IV congestive heart failure, uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months before screening.\n* 10\\. Arrhythmia requiring treatment at screening, or QTc interval (QTcB) \\>480 ms.\n* 11\\. Significant renal impairment at screening (serum creatinine \\>1.5 × ULN).\n* 12\\. Pre-transplant diagnosed gastrointestinal ulcers, history of gastric\u002Fintestinal resection surgery, or other conditions potentially affecting drug absorption.\n* 13\\. Surgery within 4 weeks before screening without full recovery.\n* 14\\. Cholestatic disease or hepatic sinusoidal obstruction syndrome\u002Fveno-occlusive disease (SOS\u002FVOD) at screening (defined as persistent bilirubin abnormality and progressive organ dysfunction not due to GVHD).\n* 15\\. Active uncontrolled viral infection at screening, e.g., CMV, EBV, HIV (anti-HIV antibody positive), HBV (HBsAg positive, HBV-DNA positive), HCV (anti-HCV antibody or HCV-RNA positive).\n* 16\\. History of active tuberculosis within 6 months before screening.\n* 17\\. Epilepsy or use of psychotropic\u002Fsedative drugs at screening.\n* 18\\. Women planning pregnancy, pregnant, or breastfeeding, or patients unable to use effective contraception throughout the trial; male patients unwilling to use condoms during treatment and for 2 days (approx. 5 half-lives) after the last dose.\n* 19\\. History of other malignancies within the past 5 years, excluding the malignancy for which transplant was performed.\n* 20\\. Other severe comorbidities deemed by the investigator to potentially affect patient safety or compliance.\n* 21\\. Suspected allergy to gecacitinib, drugs of the same class, or any excipients.\n* 22\\. Participation in other investigational drug or medical device clinical trials within 4 weeks before screening.\n* 23\\. Any other condition considered by the investigator to preclude participation.",{"count":111,"type":19},25,[22],"This trial employs a single-arm, single-center design, planning to enroll 25 patients diagnosed with grade II-IV aGVHD at one center. Patients meeting all inclusion criteria and no exclusion criteria will be enrolled. After enrollment, all patients will receive Gecacitinib combined with methylprednisolone sodium succinate for at least 28 days.\n\nAfter 28 days of Gecacitinib treatment, patients evaluated by the investigator as achieving Complete Response (CR) or Partial Response (PR) may continue study treatment for up to 24 weeks. If patients experience intolerance, disease progression, or require new systemic therapy, treatment will be adjusted.",[25],[116,117],"GVHD","JAKi","2025-09-19",{"date":120,"type":36},"2025-09-22",{"date":122,"type":19},"2025-10-01",{"date":124,"type":19},"2027-10-01",{"name":126,"class":43},"Bin Gu"]