[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"haploidentical-stem-cell-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:haploidentical-stem-cell-transplantation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100612320","phase-1-ruxolitinib-enhanced-haplo-hct-for-children-and-young-adults-with-sickle-cell-disease-100612320",false,"NCT07252050","Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease","Ruxolitinib-Enhanced Conditioning for Pediatric and Young Adult Patients With Symptomatic Sickle Cell Disease Undergoing Haploidentical Hematopoietic Cell Transplantation","RUX-HAPLO","Inclusion Criteria:\n\n1. Participants with any genotypic form of SCD aged 12 - 45 years at enrollment with ≥1 of the following:\n\n   1. History of stroke and\u002For vasculopathy, including evidence of asymptomatic cerebrovascular disease for pediatric patients.\n   2. Recurrent moderate-severe acute chest syndrome (ACS)\n   3. Recurrent vaso-occlusive pain episodes requiring parenteral analgesia despite the institution of supportive care.\n   4. Need for chronic transfusion therapy to prevent vaso-occlusive complications (i.e. pain, stroke, and ACS).\n   5. For adult patients, an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) ≥ 2.7 m\u002Fsec.\n2. Participants must have an HLA haploidentical first degree relative (parent, sibling, or half sibling) who is willing and able to donate bone marrow.\n3. Participants must meet institutional eligibility criteria for HCT.\n\nExclusion Criteria:\n\n1. Presence of an HLA-matched sibling who is willing and able to donate bone marrow.\n2. Uncontrolled infection, evidence of active TB, Hepatitis B or C infection, or HIV seropositivity or infection.\n3. Previous HCT or solid organ transplant.\n4. CNS revascularization procedure, myocardial infarction, pulmonary embolus or deep vein thrombosis in the past 6 months.\n5. Use of medications which significantly interfere with ruxolitinib metabolism.\n6. Known hypersensitivity or severe reaction to ruxolitinib or any component of the conditioning regimen or its excipients.\n7. Inability to swallow and retain oral medication (use of nasogastric or gastrostomy tube permitted).\n8. History of malignancy except resected basal cell carcinoma or treated carcinoma in-situ.\n9. Participation in another clinical trial involving an investigational or off-label use of a drug or device in the past 3 months.\n10. Currently pregnant or breast feeding.\n11. Clinically significant, uncontrolled autoimmune disease.\n12. High-titer anti-donor specific HLA antibodies (without review and approval by Study Chair).\n13. Participant (or guardian) inability or unwillingness to comply with the dose schedule and study evaluations, comprehend or sign informed consent and utilize a highly effective method of contraception (for participants of child-bearing potential).\n14. Any condition that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the subject, or interfere with interpretation of study data.","ALL","12 Years","45 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This trial will determine whether adding ruxolitinib to a reduced intensity conditioning (RIC) regimen reduces the rate of graft failure following haploidentical (haplo) hematopoietic cell transplant (HCT) for children and young adults with sickle cell disease (SCD).\n\nThis study will enroll and treat up to 24 participants. Recruitment is expected to last for about 2 years and participants will be followed for an additional 2 years post-HCT.",[29,30,31,32,33],"Sickle Cell Disease","Hematopoetic Stem Cell Transplant","Haploidentical Hematopoietic Stem Cell Transplant","Haploidentical Stem Cell Transplantation","Graft Failure",[35,36,37,38,39,40],"Sickle cell disease","Hematopoietic cell transplant","Ruxolitinib","Pediatric","Young Adult","Haplo","RECRUITING","2026-06-02",{"date":44,"type":45},"2026-06-04","ACTUAL",{"date":47,"type":22},"2026-06-08",{"date":49,"type":22},"2029-11-19",{"name":51,"class":52},"Arkansas Children's Hospital Research Institute","OTHER",4,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100607812","phase-3-reduced-post-transplant-cyclophosphamide-dose-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplantation-for-hematological-malignancies-100607812","NCT07193420","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study","REDUCy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed hematological malignancy with an indication for allogeneic HSCT\n* Presence of a haploidentical donor willing to donate PBSC\n* Patient planned to receive a thiotepa-based conditioning regimen\n* Provision of written informed consent Affiliation to a social security system (excluding \"Aide Médicale d'État\")\n\nExclusion Criteria:\n\n* Karnofsky performance status \\\u003C 70%\n* Life expectancy \\\u003C 1 month, as determined by the attending physician\n* Acute or chronic heart failure, defined as left ventricular ejection fraction \\\u003C 40%\n* Pulmonary dysfunction with diffusion capacity \\\u003C 50% of predicted values\n* Renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin (calculated using the CKD-EPI formula)\n* Decompensated hemolytic anemia\n* Fanconi anemia and other DNA breakage repair disorders\n* Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy\n* Obstruction of urinary outflow\n* Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines\n* Combination with products containing Hypericum perforatum\n* Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and\u002For life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren\n* Active non-controlled infectious disease\n* Positive HIV status\n* Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose\n* Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)\n* Hypersensitivity to the active substance or any of the excipients\n* Concurrent participation in another investigational therapeutic study\n* Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:\n\n  * Significant language barrier in the absence of adequate translation support\n  * Social or geographic situation preventing follow-up and adherence to visit schedule\n  * Ongoing substance abuse likely to interfere with protocol compliance\n  * Documented cognitive or functional impairment not otherwise covered under legal protection","18 Years",{"count":64,"type":22},180,[66],"PHASE3","Phase III comparative, open-label, randomized (1:1) trial designed to evaluate the efficacy of reducing the total dose of PTCy to 70 mg\u002Fkg on GREFS compared to the standard dose of 100 mg\u002Fkg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.",[69,70,32],"GVHD - Graft-Versus-Host Disease","HSCT",[72,73,74,75],"Cyclophosphamide toxicities","Cyclophosphamide dose reduction","Graft-Versus-Host Disease: GVHD","Hematopoietic stem cell transplantation","NOT_YET_RECRUITING","2026-05-07",{"date":79,"type":45},"2026-05-12",{"date":81,"type":22},"2026-06",{"date":83,"type":22},"2030-06",{"name":85,"class":52},"Assistance Publique - Hôpitaux de Paris",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":86},"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":96,"type":22},50,[26],"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).",[100,101,32,102],"Graft -Versus-host-disease","aGVHD","cGVHD",[104,105,106,107,108],"aGvHD","Haplo-SCT","BPC2001","BioPhoenix","KRN-7000","2025-11-20",{"date":111,"type":45},"2025-11-24",{"date":113,"type":45},"2025-10-29",{"date":115,"type":22},"2028-02-28",{"name":117,"class":118},"BioPhoenix Co., Ltd.","INDUSTRY"]