[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematopoietic-cell-transplantation-hct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematopoietic-cell-transplantation-hct":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":25,"conditions":26,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100616220","phase-1-tacrolimus-targeted-immunosuppression-cessation-in-allogeneic-hct-100616220",false,"NCT07302776","TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","Inclusion Criteria:\n\n* Eligible diseases:\n\n  * Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.\n  * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy\n  * Myelofibrosis (MF)\n  * Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy\n  * Chronic myelomonocytic leukemia (CMML)\n* Age ≥ 18 and ≤ 80 years at the time of enrollment.\n* Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.\n* Has a related or unrelated donor available who is 8\u002F8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n\nCardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n\n* Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n* Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n* Karnofsky Performance Score ≥70%\n* Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\nA female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy 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).\n\n-Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior allogeneic HCT.\n* Planned donor lymphocyte infusion (DLI).\n* Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n  2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.\n* Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n  \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT.\n\nKnown allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus\n\n* Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n* Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.\n* Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n(FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy 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).\n\n-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.\n\n\\* All subject files must include supporting documentation to confirm subject eligibility.","ALL","18 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.",[27,28,29,30,31,32,33],"GVHD","Hematopoietic Cell Transplantation (HCT)","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes","Myelofibrosis (MF)","Chronic Myeloid Leukemia (CML)","Chronic Myelomonocytic Leukemia (CMML)",[35,36],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","NOT_YET_RECRUITING","2026-04-14",{"date":40,"type":41},"2026-04-17","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2028-02",{"name":47,"class":48},"Stanford University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100601000","phase-1-momelotinib-during-and-after-hct-in-myelofibrosis-100601000","NCT07104799","Momelotinib During and After HCT in Myelofibrosis","A Phase I Study to Evaluate the Safety and Maximum Tolerated Dose of Momelotinib Durind and Following Hematopoietic Cell Transplantation for Patients With Myelofibrosis","Inclusion Criteria:\n\n* Participants must have pathologically confirmed primary myelofibrosis (PMF) according to WHO criteria or secondary myelofibrosis as defined by the IWG-MRT criteria.\n\n  * Intermediate-2\u002F high-risk disease as per Dynamic IPSS (DIPSS) Plus criteria OR\n  * Intermediate-1 risk disease with at least one of the following unfavorable features known to impact the survival adversely\n\n    * Red cell transfusion dependency\n    * Unfavorable Karyotype\n    * Platelet count ≤100 x 10\\^9\u002FL\n    * Presence of a high risk molecular marker associated with worsened overall survival (ASXL1, EZH2, IDH1\u002F2, SRSF2, U2AF1, p53)\n* Participants do not have to be receiving treatment with JAK inhibitors for MF at the time of enrollment. If participants are receiving JAK inhibitor therapy with agents other momelotinib, participants must agree to be switched to momelotinib to begin Cycle 1 Day 1 on Day -7 from HCT (at the initiation of conditioning).\n* Age \\>18 years\n* Participants must be designated to undergo allogeneic HCT with:\n\n  * reduced intensity conditioning regimen, and\n  * peripheral blood stem cells as a graft source\n* Participants who will undergo HCT from the following donor types are eligible:\n\n  * 6\u002F6 (HLA-A, B, DR) fully matched related donor or\n  * 8\u002F8 (HLA-A, B, DR, C) fully matched unrelated donor. Matching in the unrelated setting must be at the allele level\n* ECOG performance status ≤2 (Karnofsky ≥60%)\n* The effects of momelotinib on the developing human fetus are unknown. Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing. Women of childbearing potential: must agree to use highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 1 week after the last dose of momelotinib.\n\nMale participants with women of child bearing potential partners must agree to use one of the forms of medically acceptable birth control at start of the first treatment, during the study, and for at least 6 months after the last dose. See Exclusion Criteria for effective contraception and birth control.\n\n\\- Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Known intolerance or hypersensitivity to any JAK inhibitor, including ruxolitinib, fedratinib, pacritinib, momelotinib or any other JAK inhibitor, its metabolites or formulation excipients.\n* Has had any major surgery within 28 days prior to randomization\n* Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention\n* Has received immunosuppressive agents within 28 days\n* Prior allogeneic transplant for any hematopoietic disorder\n* Had accelerated phase or leukemic transformation (≥10% blasts in bone marrow any time prior to HCT)\n* Has an active, uncontrolled infection\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Known diagnosis of active hepatitis B or hepatitis C.\n* History of another malignancy(ies), unless:\n\n  * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\n  * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up\n  * the only prior malignancy was cervical cancer in situ and\u002For basal cell or squamous cell carcinoma of the skin\n* Participants without normal organ function defined as follows:\n\n  * AST (SGOT), ALT (SGPT) and Alkaline Phosphatase \\>3 × institutional Upper Limit of Normal (ULN)\n  * Total bilirubin \\>1.5 mg\u002FdL, with the exception of participants with Gilbert's Syndrome provided direct bilirubin is ≤1.5x ULN and participant otherwise meets entry criteria.\n  * Calculated creatinine clearance ≤60 mL\u002Fmin (Cockcroft-Gault formula)\n  * Have current or a history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \\\u003C 40%, as measured by MUGA scan or echocardiogram) or clinically significant arrhythmia not controlled by standard of care therapy.\n* Not able to take oral medication or having any clinically significant gastrointestinal abnormalities that may alter absorption, e.g., malabsorption syndrome or major resection of the stomach and\u002For bowels.\n* Grade 2 or greater peripheral neuropathy\n* Pregnant or lactating women, or women planning to become pregnant or initiating breastfeeding.\n* To exclude women of childbearing potential: who are unwilling or unable to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 1 week after the last dose. Highly effective contraceptive measures include:\n\n  * stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n  * intrauterine device (IUD); intrauterine hormone-releasing system (IUS);\n  * sexual abstinence;\n  * intercourse with vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure).\n* To exclude sexually active male participants with WOCBP partners who are unwilling to use the one of the following forms of medically acceptable birth control at start of the first treatment, during the study, and for at least 6 months after the last dose:\n\n  * vasectomy with medical assessment of surgical success OR consistent use of a condom.\n  * male participants must also agree not to donate sperm while receiving study drug and for at least 6 months after the last dose.\n* Patients receiving strong CYP 3A4 inducers during study period\n* Patients with major ABO mismatch donors only",{"count":58,"type":21},28,[24],"This is a single-center, open-label, phase I study to determine the safety and tolerability of momelotinib in patients with myelofibrosis during and after hematopoietic cell transplantation (HCT).",[62,28],"Myelofibrosis",[64,65,66],"myelofibrosis","allogeneic hematopoietic cell transplantation (HCT)","HCT","RECRUITING","2026-03-30",{"date":70,"type":41},"2026-03-31",{"date":72,"type":41},"2026-02-23",{"date":74,"type":21},"2030-01",{"name":76,"class":48},"Massachusetts General Hospital"]