[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml-acute-myeloid-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,48,73,102,134,155,183,208,230,254,277,298,322,345,365,391,420],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619653","phase-1-cd64-car-t-cell-therapy-in-adults-with-relapsed-andor-refractory-aml-100619653",false,"NCT07347418","CD64 CAR T Cell Therapy in Adults With Relapsed and\u002For Refractory AML","Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety, Expansion, Persistence, and Preliminary Clinical Activity of Autologous CD64 CAR T Cells in Patients With Relapsed and\u002For Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Subjects must have one of the following diagnoses per the International Consensus Classification (ICC) 2022 criteria:\n\n   a. Acute Myeloid Leukemia (AML).\n3. Refractory OR relapsed AML:\n\n   a. Refractory disease i. ≥5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry, or immunohistochemistry after a minimum of 1 cycle of a hypomethylating agent (HMA) and venetoclax (Ven) combination (Ven\u002FHMA) b. Relapsed disease i. Recurrence of ≥ 5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry or immunohistochemistry.\n4. Subjects must have received at least one prior line of therapy, including at least one line of therapy containing Ven.\n5. Documentation of CD64 expression on ≥70% of myeloid blasts by flow cytometry after the most recent relapse, as determined by standardized and validated multiparameter flow cytometry assay (Hematologics, Inc., Seattle, WA).\n6. Total white blood cell (WBC) count ≤ 25 x 10(to the 9th)\u002FL prior to apheresis. Hydroxyurea is permitted to achieve this\n7. Absolute lymphocyte count (ALC) ≥ 200\u002FµL prior to apheresis OR ALC \\\u003C 200 µL with concurrent lymphocyte subset analysis (CD3, CD4, and CD8 counts) confirming an absolute CD3 count ≥ 150\u002FµL.\n8. Confirmed availability of cells for a rescue stem cell transplant AND subject must be deemed an appropriate candidate for such therapy per institutional standards.\n9. Subjects who have undergone prior allogeneic stem cell transplant must be ≥ 6 months out from transplant and be off systemic immunosuppression for at least 1 month at the time of enrollment with no evidence of active graft versus host disease.\n10. Adequate organ function, defined as:\n\n    1. Creatinine clearance ≥ 30 mL\u002Fmin, based on the CKD-EPI Creatinine Equation (2021).\n    2. AST\u002FALT ≤ 5x upper limit of the normal range, unless considered to be due to leukemic involvement.\n    3. Bilirubin ≤ 3x upper limit of the normal range, unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement.\n    4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air, unless considered to be due to leukemic involvement.\n    5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO\u002FMUGA.\n11. ECOG performance status 0, 1, or 2.\n12. Signed informed consent form.\n13. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in the protocol main text.\n14. Willing to participate in the long-term follow-up protocol that is required if CAR T cell therapy is administered.\n\nExclusion Criteria:\n\n1. Subjects with Acute Promyelocytic Leukemia (APL) with t(15;17)\n2. Receipt of previous chemotherapy for AML, as follows:\n\n   a. Prior to apheresis, the following washout periods apply: i. Hydroxyurea: 1 day ii. Hypomethylating agent and\u002For venetoclax: 7 days iii. Small molecule targeted therapy (including tyrosine kinase inhibitors): 3 half-lives or 7 days, whichever is shorter.\n\n   iv. Immune checkpoint inhibitors or other immunological agents: 5 half-lives or 28 days, whichever is shorter.\n\n   v. Investigational products: 5 half-lives or 28 days, whichever is shorter. vi. Any other systemic chemotherapy: 14 days vii. Allogeneic stem cell transplantation: 180 days viii. Donor lymphocyte infusion (DLI): 60 days ix. Craniospinal or total body radiation: 42 days b. After apheresis and prior to lymphodepletion, no treatment for AML is permitted, with the exception of bridging hydroxyurea with a washout period of 1 day prior to the start of the lymphodepletion regimen.\n3. Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.\n4. Previous treatment with investigational gene or cell therapy (including CAR therapy).\n5. Signs or symptoms indicative of CNS leukemia involvement. A CNS evaluation should be performed if CNS involvement is suspected to rule out CNS leukemia involvement.\n6. Pregnant or lactating (nursing) women.\n7. Known HIV infection or active Hepatitis B or Hepatitis C infection.\n8. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).\n9. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n10. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.\n11. Subjects with cardiac arrhythmia, or arrhythmias that are not stable with medical management, within 2 weeks of the Screening\u002FEnrollment visit.\n12. Any uncontrolled active medical disorder that would preclude participation as outlined.\n13. Evidence of another uncontrolled malignancy.\n\nApheresis Eligibility To proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21 days prior to apheresis, unless otherwise specified.\n\nNote: Disease evaluation (bone marrow aspirate and biopsy) to meet inclusion criteria must be completed within 30 days prior to enrollment.\n\nLymphodepleting Chemotherapy Eligibility To proceed with lymphodepleting chemotherapy, enrolled participants must have specific assessments completed and continue to meet all inclusion criteria within 72 hours of initiation of lymphodepletion\n\nCD64 CAR T Infusion Eligibility\n\nParticipants must meet the following criteria in order for cells to be infused (based on labs obtained within 24 hours of cell infusion):\n\n* CD64 CAR T must have met manufacturing criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA)\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* Performance status determination (ECOG must be 0, 1 or 2).\n* Participant remains clinically stable without evidence of vital sign instability including the lack of supportive vasoactive drugs or intensive care support.\n* Must not have ALT\u002FSGPT and AST\u002FSGOT \\> 10x the ULN or total bilirubin \\> 3x the ULN, (unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement)\n* Adequate renal function, as defined in the Inclusion Criteria.\n* No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator.","ALL","18 Years",{"count":19,"type":20},23,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ\u002F4-1BB) costimulatory domains in subjects with refractory or relapsed (R\u002FR) acute myeloid leukemia (AML). This CAR T cell product will be referred to as \"CD64 CAR T\" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R\u002FR AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.",[26,27,28,29],"Refractory Acute Myeloid Leukemia (AML)","Relapsed Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome","AML (Acute Myeloid Leukemia)",[31,32,33,34],"AML","CD64","CAR T","CAR T cell","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":20},"2026-06",{"date":43,"type":20},"2032-06",{"name":45,"class":46},"University of Colorado, Denver","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100641669","phase-2-chidamide-venetoclax-azacitidine-and-homoharringtonine-for-high-risk-fit-aml-100641669","NCT07643636","Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML","A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients","Inclusion Criteria:\n\n1. Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.\n2. Age ranging from 18 to 60 years, no restriction on gender.\n3. No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose \\\u003C1.0 g) is permitted as exception.\n4. Estimated overall survival ≥12 weeks.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.\n6. Renal function: calculated creatinine clearance (CrCl) ≥30 mL\u002Fmin.\n7. Hepatic function: alanine aminotransferase (ALT) \\\u003C5× upper limit of normal (ULN); total bilirubin \\\u003C3× ULN.\n8. Able to provide written informed consent and understand as well as comply with all study-specified procedures.\n\nExclusion Criteria:\n\n1. Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.\n2. Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.\n3. Cardiac function exceeding NYHA functional class II.\n4. Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:\n\n   * Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention.\n\n6\\. Patients unable to receive oral chidamide and\u002For venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion","60 Years",{"count":57,"type":20},46,[59],"PHASE2","This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.",[29],"NOT_YET_RECRUITING","2026-06-16",{"date":65,"type":39},"2026-06-18",{"date":67,"type":20},"2026-06-30",{"date":69,"type":20},"2029-06-01",{"name":71,"class":72},"Dongguan People's Hospital","OTHER_GOV",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":55,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100642715","haplo-cord-hsct-for-amlmds-100642715","NCT07588360","Haplo-Cord HSCT for AML\u002FMDS","Haploidentical Combined With Cord Blood Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes: A Prospective, Multicenter Clinical Study","Inclusion Criteria:\n\n* Age between 14 and 60 years, with no gender restriction.\n* Intermediate- or high-risk AML in first complete remission (CR1).\n* AML in second or subsequent complete remission (≥ CR2).\n* Relapsed or refractory AML.\n* Low-risk AML meeting any of the following: Failure to achieve a ≥3-log reduction in RUNX1::RUNX1T1 transcript level compared with baseline after 2 consolidation cycles, or loss of major molecular remission (MMR) within 6 months; CBFB::MYH11\u002FABL ratio \\> 0.1% at any time point after 2 consolidation cycles in patients with CBFB::MYH11-rearranged AML; Presence of D816 KIT mutation in patients with CBFB::MYH11-rearranged AML; Flow cytometry-positive MRD at any time point after 2 consolidation cycles in patients with CEBPA double-mutant AML; Persistently positive MRD after chemotherapy in patients with NPM1-mutated AML.\n* Intermediate-2 or high-risk MDS according to the IPSS scoring system.\n* Adequate general health status and ability to tolerate hematopoietic stem cell transplantation.\n* Provision of signed informed consent and willingness to comply with study-required follow-up and examinations.\n\nExclusion Criteria:\n\n* Prior history of other hematopoietic stem cell transplantation.\n* History of ex vivo T-cell-depleted stem cell transplantation.\n* Survival duration of less than 1 month after transplantation.\n* Severe organ dysfunction, including significant impairment of hepatic, renal, cardiac, or pulmonary function.\n* Active severe infection, such as uncontrolled pneumonia, sepsis, or other systemic infections.\n* History of severe hypersensitivity reactions to study medications, including cyclophosphamide or anti-thymocyte globulin (ATG).\n* Presence of severe psychiatric disorders or cognitive impairment that precludes compliance with study treatment and follow-up.\n* Pregnant or lactating women.\n* Concurrent malignancy of other organ system.\n* Any other medical conditions deemed inappropriate for study participation by the treating investigators.","14 Years",{"count":82,"type":20},82,[84],"NA","This study aims to investigate the clinical efficacy of haploidentical-cord blood hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), and to analyze the impact of different engraftment patterns (haploidentical engraftment versus cord blood engraftment) on clinical outcomes. By comparing the efficacy of haploidentical-cord blood transplantation in different subtypes of AML and MDS, this research will explore its unique advantages and comparative effectiveness relative to conventional transplantation strategies, so as to provide new evidence for clinical practice.\n\nSpecific research objectives I. To evaluate the efficacy of haploidentical-cord blood hematopoietic stem cell transplantation for AML and high-risk MDS, including the speed of hematopoietic recovery, immune tolerance, and long-term survival rates.\n\nII. To compare the effects of different engraftment patterns (haploidentical engraftment vs. cord blood engraftment) on quality of life, immune tolerance, early complications, and long-term prognosis.\n\nIII. To identify the clinical advantages and indications of haploidentical-cord blood transplantation through data analysis, and to provide a theoretical basis for clinical decision-making.\n\nNovelty of the Study I. Innovation in Hematopoietic Stem Cell Infusion Schedule The present study employs a sequential infusion strategy: haploidentical stem cells are infused on Day 0, and umbilical cord blood cells are infused on Day +6 after transplantation.In contrast to the conventional approach used at most domestic and international centers (including the uzhou Protocol), in which both stem cell sources are infused simultaneously on Day 0, the current protocol delays cord blood infusion. This design confers potential advantages for immune reconstitution and long-term cord blood engraftment.\n\nII. Unique Myeloablative Conditioning Regimen\n\nThe conditioning regimen used in this study is as follows:\n\nFludarabine 25 mg\u002Fm² for 5 days, Cytarabine 2 mg\u002Fm² for 5 days, intravenous Busulfan 3.2 mg\u002Fkg for 3 days, ATG 5 mg\u002Fm² for 2 days, Melphalan 60 mg\u002Fm² for 2 days, and CTX 50.0 mg\u002Fkg daily for 2 days.\n\n(For patients in complete remission (CR) with negative MRD before transplantation, Fludarabine and Cytarabine are administered for 3 days instead of 5 days.) Distinct from regimens at other centers, our team administers cyclophosphamide within the critical window after haploidentical stem cell infusion but before cord blood infusion, establishing a novel sequential conditioning model. This approach balances myeloablative intensity and immunomodulation, creating a favorable environment for subsequent long-term cord blood engraftment.\n\nIII. Engraftment Outcomes and Clinical Value Preliminary clinical experience demonstrates that haplo-cord sequential transplantation following the FA5Cy2Bu3 conditioning regimen combined with low-dose ATG\u002FPTCY can achieve long-term cord blood engraftment in approximately 50% of patients.\n\nBy comparison, other domestic protocols (e.g., the Suzhou Protocol) rarely result in sustained cord blood engraftment.\n\nAchievement of long-term cord blood engraftment is clinically meaningful for reducing relapse rates, lowering the incidence and severity of graft-versus-host disease (GVHD), and improving patient prognosis. These outcomes represent a key advantage of the present protocol.",[87,29],"MDS (Myelodysplastic Syndrome)",[89,90,91],"Acute Myeloid Leukemia(AML)","Myelodysplastic Syndrome(MDS)","haplo-cord HSCT","2026-06-08",{"date":94,"type":39},"2026-06-10",{"date":96,"type":39},"2025-10-20",{"date":98,"type":20},"2029-06-30",{"name":100,"class":46},"Fujian Medical University Union Hospital",4,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":133},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":110,"type":20},16,[112],"PHASE4","A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[29,115,116,117],"Glioma","Cholangiocarcinoma","Solid Tumor Malignancies",[119,120,121,122],"IDH1 Mutation","Hematology and Oncology","Oncology","Drug-Drug Interactions","2026-06-03",{"date":125,"type":39},"2026-06-05",{"date":127,"type":39},"2026-02-23",{"date":129,"type":20},"2027-06-30",{"name":131,"class":132},"Rigel Pharmaceuticals","INDUSTRY",2,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100637763","phase-2-ivosidenib-as-maintenance-therapy-in-transplant-ineligible-idh1-mutated-aml-and-hr-mds-100637763","NCT07607418","Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS","A Phase II, Multicenter, Open-label Clinical Study of Ivosidenib as Maintenance Therapy in Patients With IDH1-mutated AML and High-risk MDS Who Are Ineligible for Transplantation (IVORY-MAST)","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Molecularly confirmed diagnosis of IDH1-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).\n* Achieved complete remission (CR) or partial remission (PR) after induction therapy.\n* Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n* Signed informed consent.\n* For women of childbearing potential: must have practiced contraception for at least one month prior to screening and commit to using contraception throughout the study period and for the required period after study completion.\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective methods of contraception from the time of signing informed consent until 180 days after the last dose of the study drug.\n\nExclusion Criteria:\n\nParticipants with any of the following criteria will be excluded from the study:\n\n* Prior treatment with an IDH1 inhibitor.\n* Diagnosis of M3 subtype (acute promyelocytic leukemia, APL).\n* Presence of severe hepatic or renal dysfunction.\n* Active infection or other serious comorbidities.\n* Major surgery within 28 days prior to the first dose, or planned surgery during the study period.\n* Diagnosis of any other malignancy within 5 years prior to the first dose, with the exception of early-stage malignancies that have been cured by radical treatment, such as carcinoma in situ of the lung, non-melanoma skin cancer, basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Whether to exclude such patients will be determined by the investigator's assessment.\n* Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to randomization.\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA≥1000 IU\u002Fml); hepatitis C (positive for anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C.\n* Known history of psychoactive substance abuse or drug addiction.\n* Presence of any other serious physical or mental illness, or abnormal laboratory findings that may increase the risk of study participation, interfere with the study results, or make the patient unsuitable for study participation in the opinion of the investigator.\n* Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption.\n* Previous concomitant treatment with both drugs of the combination therapy targeting the same pathway as in this study.\n* History of allergy to the study drug or any of its excipients.",{"count":142,"type":20},20,[59],"This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker research. Patients who meet the eligibility criteria will receive ivosidenib treatment until disease progression or unacceptable toxicity. This study will provide an effective maintenance treatment option for transplant-ineligible patients with IDH1-mutated AML and high-risk MDS.",[29,87],"2026-05-19",{"date":148,"type":39},"2026-05-26",{"date":150,"type":20},"2026-05-22",{"date":152,"type":20},"2027-12-30",{"name":154,"class":46},"Ruijin Hospital",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":133},"100635435","phase-2-matched-sibling-allogenic-stem-cell-transplantation-with-adoptive-immunotherapy-with-regulatory-and-conventional-t-cells-for-high-risk-acute-myeloid-leukemia-100635435","NCT07552649","Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia","MATCH-Treg: Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia","MATCH-Treg","Inclusion Criteria:\n\n* Diagnosis of AML with adverse genetic mutations in Complete Remission (CR) or incomplete (i) CR according to ELN 2022 recommendations with or without MRD positivity at the time of the HSCT procedure;\n* Diagnosis of AML with intermediate genetic mutations in Complete remission (CR) or incomplete (i) CR according to ELN 2022 with MRD positivity at the time of the transplant;\n* Fitness to undergo allo-HCT with myeloablative conditioning regimens according to center policy;\n* Availability of a family HLA-matched hematopoietic stem cell donor suitable to be treated with G-CSF (10 mcg\u002Fkg\u002Fdie) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n* Age ≥ 18 and ≤ 70 years\n* ECOG ≤ 2\n* HCT-CI ≤ 4\n* Signature of the informed consent\n\nExclusion Criteria:\n\n* Prior allo-HSCT\n* AML with favorable genetic abnormalities\n* AML with intermediate genetic risk with MRD negativity\n* Active disease at transplant (\\> 5% bone marrow infiltration)\n* Availability of a haploidentical or matched unrelated donor (MUD)\n* Age \\\u003C 18 years or \\> 70 years\n* ECOG \\> 2\n* Unacceptable lung, liver, kidney, and\u002For heart function and presence of relevant psychiatric diseases according to clinical judgment\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment\n* Pregnancy\n* No signature of the informed consent","70 Years",{"count":165,"type":20},28,[59],"The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg\u002FTcon adoptive immunotherapy for high-risk AML patients.",[29],[170,171,172,173],"allogeneic stem cell transplantation","adoptive immunotherapy","Treg","high-risk AML","2026-04-20",{"date":176,"type":39},"2026-04-27",{"date":178,"type":20},"2026-04",{"date":180,"type":20},"2030-04",{"name":182,"class":46},"Antonio Pierini",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":163,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":47},"100632526","phase-2-va-cig-regimen-for-previously-untreated-acute-myeloid-leukemia-a-multicenter-prospective-single-arm-trial-100632526","NCT07514832","VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial","A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML;\n* Age 18-70 years, with no gender restriction;\n* No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts;\n* Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A);\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* Serum creatinine ≤ 2.0 × upper limit of normal (ULN), or creatinine clearance \\> 40 mL\u002Fmin calculated by the Cockcroft-Gault formula for glomerular filtration rate (GFR);\n* Total bilirubin ≤ 2 × ULN, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN;\n* Left ventricular ejection fraction (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range;\n* Expected survival \\> 3 months.\n\nExclusion Criteria:\n\n* Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation;\n* Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases;\n* Known hypersensitivity to any component of the investigational medicinal products;\n* History of other concurrent malignancies within 2 years prior to enrollment, except:\n\nAdequately treated carcinoma in situ of the cervix or breast; Basal cell carcinoma or localized squamous cell carcinoma of the skin; Previously controlled malignancies treated with radical surgical resection (or other curative modalities), etc.\n\n* Presence of uncontrolled severe infection or active bleeding;\n* Pregnant or lactating women;\n* Subjects with active, treatment-uncontrolled viral infection caused by HIV, hepatitis B virus, or hepatitis C virus;\n* Subjects with evidence of central nervous system leukemia before treatment initiation;\n* Women of childbearing potential who do not agree to use at least one reliable contraceptive method from Day 1 of the study until 90 days after the last dose of study medication; sexually active male subjects who do not agree to use contraceptive measures from Day 1 of the study until 90 days after the last dose of study medication; male subjects who do not agree to refrain from sperm donation from the start of study drug administration until at least 90 days after the last dose;\n* Subjects with epilepsy requiring pharmacotherapy, dementia, or other abnormal psychiatric conditions that impair the ability to understand or comply with the study protocol;\n* Presence of psychiatric disorders or cognitive impairment that prevents cooperation with treatment and follow-up; conditions limiting oral drug intake or gastrointestinal absorption.",{"count":191,"type":20},48,[59],"This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \\[G-CSF\\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.",[29],[31,196,197,198],"Venetoclax","chemotherapy","BCL2 inhibitor","2026-03-31",{"date":201,"type":39},"2026-04-07",{"date":203,"type":20},"2026-04-15",{"date":205,"type":20},"2028-12-31",{"name":207,"class":46},"Beijing 302 Hospital",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":218,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":47},"100632295","wearable-technology-for-collecting-health-data-in-people-who-are-the-transfused-watch-transfused---a-uk-exploratory-study-to-improve-quality-of-life-and-the-efficacy-of-transfusion-supportive-care-in-people-with-blood-cancers-undergoing-treatment-100632295","NCT07511829","WearAble Technology for Collecting Health Data in People Who Are the Transfused (WATCH Transfused) - A UK Exploratory Study to Improve Quality of Life and the Efficacy of Transfusion Supportive Care in People With Blood Cancers Undergoing Treatment","WATCH Tranfuse","Inclusion Criteria:\n\n* Patients aged ≥18 years with WHO-defined MDS or mixed myeloproliferative\u002Fmyelodysplastic neoplasm overlap syndromes (MPN\u002FMDS), myeloma and AML\n* Intention to undertake disease modifying treatment\n* Life expectancy ≥ 6 months\n* Able to complete quality of life questionnaires\n* Willing and able to provide informed consent for participation in the study\n* Willing to receive blood products as part of normal NHS care\n\nExclusion Criteria:\n\n* Poor performance\u002Ffunctional status (Eastern Cooperative Oncology Group system ECOG ≥3)\n* Participants with known arrhythmias or other significant cardiological conductivity disorders\n* Patients with severe comorbidities\n* Patients with known skin allergies or conditions that in the opinion of the investigator would compromise the safety of the patient or quality of the data\n* Hospitalised patients\n* Patients currently participating in another interventional clinical study\n* Patients with a pacemaker or implanted cardioverter defibrillator or any cardiac implanted device",{"count":216,"type":20},80,"2 Months","OBSERVATIONAL","Cancer treatments such as chemotherapy often affect healthy cells as well as the cancer cells and this can lead to side-effects such as low blood counts - anaemia. This can cause severe fatigue, shortness of breath and brain fog and may need regular blood transfusions. Their quality of life (QoL) is often very poor during treatment because of these side effects, and it is hard to deal with.\n\nDoctors use blood tests to decide whether a patient is well enough for treatment and when to start treatment. However, blood tests do not tell us how a person feels, and it is not the same in everyone. We need a better way for doctors to monitor patients' QoL and these symptoms so that they are physically and emotionally able to continue their treatment. It is hard for doctors to accurately assess this through speaking to their patients and doctors do not record or discuss these effects of treatment very well with patients.\n\nThe aim of this study is to better understand how people feel during their treatment and how we can best use blood transfusions to maintain QoL.\n\n80 adult patients who are starting blood cancer treatments will be asked to answer questionnaires about how they are feeling and their symptoms during their treatment. Participants will be asked to wear a smartwatch to measure their physical activity levels. Activity data collected will then be compared with their reported QoL and blood counts to help us understand when patients can tolerate difficult treatments the best and how blood transfusions affect this.\n\nPatients, their family and carers will be invited to take part in an interview to understand their views on how we can improve their care, QoL and access to transfusions.\n\nA better understanding of the impact of low blood counts on QoL can help us use blood transfusions to benefit patients' lives. This work will better match transfusions to individual peoples' needs and therefore 'personalise' blood transfusion care.",[87,29],"2026-03-30",{"date":223,"type":39},"2026-04-06",{"date":225,"type":39},"2026-02-17",{"date":227,"type":20},"2027-09-01",{"name":229,"class":46},"University of Oxford",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100625682","phase-2-flt3-itd-targeted-therapy-in-fit-aml-patients-100625682","NCT07425808","FLT3-ITD Targeted Therapy in Fit AML Patients","Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy \"7+3\" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.","FIT-AML","Inclusion Criteria:\n\n* Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification\n* Age between 18 and 75 years\n* FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD \u002F FLT3-wild type (WT) ratio of ≥ 0.05 (5%))\n* Eligibility for standard induction chemotherapy\n* ECOG PS ≤ 2\n* WBC ≤25 x 10\\^9\u002FL (hydroxyurea, leukapheresis or cytarabine in specific clinical circumstances, are allowed to meet this criterion. Please refer to Section 4.1.1 - Inclusion Criteria).\n* Adequate hepatic function (as indicated by total serum bilirubin level ≤2.5 x the institutional upper limit of normal range (UNL), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the investigator; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 x UNL)\n* Adequate renal function as defined by an eGFR ≥ 30 mL\u002Fmin according to the 2021 CKD-EPI equation\n\nMain Exclusion Criteria:\n\n* Acute promyelocytic leukemia (APL)\n* BCR-ABL positive leukemia or Ph1-positive chronic myeloid leukemia\n* History of myeloproliferative neoplasm (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera\n* Active central nervous system involvement by AML\n* Active, uncontrolled infection (viral, bacterial or fungal): an infection controlled with an approved or closely monitored antibiotic\u002Fantifungal treatment is allowed.\n* HIV, HBV or HCV active infection\n* Grade \\>3 CTCAE (v. 6) clinically relevant (as per local investigator) adverse events at the time of enrolment\n* Prior treatment for myelodysplastic syndrome (MDS) with Venetoclax or hypomethylating agents (decitabine, azacitidine).\n* Any prior AML therapies (except for emergency treatment with hydroxyurea or cytarabine for hyperleukocytosis) Note: Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid, but who are found not to have APL, are eligible (treatment with all-trans retinoic acid must be discontinued before starting induction chemotherapy).\n* Any prior treatment with a FLT3 inhibitor\n* Serious organ dysfunction as left ventricular ejection fraction \\\u003C40%, FEV1, FVC, DLCO (diffusion capacity) \\\u003C40% of predicted\n* Cardiovascular disability status of New York Heart Association class ≥ 2\n* Congenital long QT syndrome or QT Interval Corrected Using Fridericia's Formula (QTcF) \\>450 msec Note: repeat electrocardiograms after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\>450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.\n* Participant with a prior or concurrent malignancy or autoimmune disease requiring immunosuppressive therapy.\n\nNote: diseases whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the 2467 medical monitor and the study coordinator.\n\n* Consumed strong or moderate inducers of Cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 14 days of study enrolment or requiring treatment with such a medication during the trial.\n* Inability to swallow and\u002For any gastrointestinal disorders, malabsorption or other abnormalities that would interfere with absorption of the oral study drug.\n* Other life-threatening concurrent disease.","75 Years",{"count":240,"type":20},230,[59,242],"PHASE3","This international, multicenter, randomized (1:1), open-label phase II\u002FIII trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard \"7+3\" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.",[29],"2026-02-20",{"date":127,"type":39},{"date":248,"type":20},"2026-12-01",{"date":250,"type":20},"2032-02-01",{"name":252,"class":253},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":163,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":47},"100621395","phase-1-clinical-study-of-anti-cll1-cd33-nkg2d-bicephali-car-t-for-relapsedrefractory-acute-myeloid-leukemia-100621395","NCT07370064","Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase I\u002FII Study to Evaluate the Safety and Efficacy of Anti-CLL1-CD33-NKG2D Bicephali CAR-T Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","AML CAR-T","Inclusion Criteria:\n\nAge: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria.\n\nPrior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy.\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nAdequate Organ Function:\n\nHematologic function: Absolute neutrophil count (ANC) ≥ 1,000\u002FμL, platelet count ≥ 50,000\u002FμL, and hemoglobin ≥ 8 g\u002FdL (without transfusion support).\n\nRenal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST\u002FALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study.\n\nEligible for Apheresis: Patients must be able to undergo the apheresis procedure to collect T cells for CAR-T cell modification.\n\nExclusion Criteria:\n\nActive Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS.\n\nPregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections.\n\nOther Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years.\n\nAutoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy.\n\nHistory of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy.\n\nAllergy to Apheresis or CAR-T Cell Components: Known hypersensitivity to any of the components involved in the apheresis or CAR-T cell therapy procedure.\n\nUncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions.\n\nConcurrent Participation in Another Clinical Trial: Participation in another clinical trial for AML or related conditions that may interfere with this study's treatment and outcomes.\n\nInability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.",{"count":142,"type":20},[23,59],"This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed\u002Frefractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.\n\nThe primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.\n\nEligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.\n\nPatients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.",[29],[267],"CAR-T","2026-01-18",{"date":270,"type":39},"2026-01-27",{"date":272,"type":20},"2026-01-31",{"date":274,"type":20},"2029-01-31",{"name":276,"class":46},"Xuzhou Medical University",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":47},"100619255","safety-and-efficacy-of-cll1-car-t-followed-by-allogeneic-hematopoietic-stem-cell-transplantation-in-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100619255","NCT07342244","Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments as required by the study protocol.\n\nAge between 18-75 years (inclusive), gender not restricted. Confirmed diagnosis of acute myeloid leukemia (AML), with prior receipt of at least one course of systemic chemotherapy, and efficacy assessment showing relapse\u002Frefractory disease.\n\nFlow cytometry of bone marrow examination or immunohistochemistry of tumor pathology at screening confirms positive expression of CLL1 target.\n\nPatients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is tumor-related or judged by the investigator to be in a stable state with little impact on safety or efficacy).\n\nECOG performance status score 0-2 and expected survival time \\> 3 months. Adequate organ function:a) Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)b) Aspartate aminotransferase (AST) ≤ 3 × ULNc) Total bilirubin ≤ 1.5 × ULNd) Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmine) Hemoglobin ≥ 60 g\u002FL or maintained at this level after blood transfusionf) Indoor oxygen saturation ≥ 92%g) Left ventricular ejection fraction (LVEF) ≥ 45% Capable of establishing venous access required for apheresis, with no contraindications to leukapheresis.\n\nExclusion Criteria:\n\n* History of other malignancies within 3 years prior to screening, except for adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin carcinoma, locally treated prostate cancer after radical treatment, and ductal carcinoma in situ after radical treatment.\n\nDiagnosis of Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis at screening.\n\nPositive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with HBV DNA titer in peripheral blood above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive HCV-RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA quantitative test above the lower limit of detection of the research institution; positive for Treponema pallidum antibody; Epstein-Barr virus (EBV) DNA quantitative test above the lower limit of detection of the research institution.\n\nHistory of severe allergic reactions \\[severe allergic reaction is defined as grade 2 or higher allergic reaction, with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest\\] or known hypersensitivity to any active ingredients, excipients of the study drugs (including lymphodepletion regimen), murine products, or heterologous proteins.\n\nHistory of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after \\>1 month of treatment with ≥3 antihypertensive drugs (including diuretics) at reasonable and tolerable maximum doses, or requires ≥4 antihypertensive drugs to effectively control blood pressure).\n\nUnstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring medical treatment.\n\nPrevious organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).\n\nPrevious receipt of CAR-T therapy. History of acute\u002Fchronic graft-versus-host disease (GVHD) within 6 months prior to screening, or patients requiring immunosuppressive therapy for GVHD.\n\nActive autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).\n\nPresence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring urgent treatment at screening or before infusion.\n\nUncontrolled bacterial, fungal, viral or other infections requiring antibiotic treatment.\n\nUse of short-acting hematopoietic cytokines affecting blood counts within 1 week prior to planned blood collection for CAR-T manufacturing, or use of long-acting hematopoietic cytokines within 2 weeks prior to screening, and judged by the investigator to have an impact on cell manufacturing.\n\nReceipt of corticosteroids or immunosuppressive drugs within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening, and judged by the investigator to have an impact on cell manufacturing:a) Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use).b) Immunosuppressants: Subjects receiving immunosuppressive therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening.\n\nMajor surgical procedures (except diagnostic surgery and biopsy) within 4 weeks prior to lymphodepletion or planned major surgery during the study period, or surgical wounds not fully healed before enrollment.\n\nVaccination with (attenuated) live viral vaccines within 4 weeks prior to screening.\n\nPresence of severe mental illness. History of alcoholism or drug abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.\n\nSubjects with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks, as judged by the investigator and\u002For according to clinical standards.","78 Years",{"count":285,"type":20},18,[84],"This study aims to evaluate whether an innovative combination therapy (CLL1 CAR-T sequential allogeneic hematopoietic stem cell transplantation) is safe, feasible and effective for the treatment of relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML).",[31,29],"2026-01-07",{"date":291,"type":39},"2026-01-15",{"date":293,"type":20},"2026-01-30",{"date":295,"type":20},"2029-12-20",{"name":297,"class":46},"Donghua Zhang",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":305,"maxAge":17,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":318,"leadSponsor":320,"locationsCount":4},"100618956","early-phase-1-clinical-study-of-cll-1-car-t-in-the-treatment-of-children-with-rr-aml-100618956","NCT07338357","Clinical Study of CLL-1 CAR-T in the Treatment of Children With R\u002FR AML","A Single-Center Clinical Study Evaluating the Safety and Preliminary Efficacy of CLL-1 CAR-T in the Treatment of Children With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Voluntarily sign the ICF and are expected to complete the study's follow-up examinations and procedures.\n2. Aged 3 to 18 years (inclusive), and body weight ≥10 kg.\n3. Diagnosis of AML according to the 2016 WHO classification, meeting the diagnostic criteria for relapse and refractoriness as per the \"Chinese Guidelines for Diagnosis and Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia (2017 Edition)\", and currently having no clinically relevant treatment options or suitable registered clinical trials available.\n4. Confirmation of CLL-1 expression ≥50% on AML blasts by flow cytometry.\n5. Recovery from toxicities of prior therapies.\n6. Karnofsky score (for age ≥16 years) ≥70 or Lansky score (for age \\\u003C16 years) ≥50 at screening, and an expected survival \\>3 months.\n7. Suitable function of the liver, kidneys, hematological system, lungs and heart is required.\n8. Females subjects of childbearing potential must have a negative blood pregnancy test at screening and agree to use effective contraception during the study and within 1 year after the last dose of study drug.\n9. Male subjects with reproductive potential must agree to use barrier contraception or practice complete abstinence until 1 year after the last study treatment.\n10. Eligible blood cell specimen can be provided.\n\nExclusion Criteria:\n\n1. Diagnosis of APL.\n2. History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.\n3. Evidence of CNS involvement or cranial nerve pathology.\n4. Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded.\n5. Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded.\n6. Subjects with severe cardiac diseases, refractory hypertension, active neurological autoimmune or inflammatory diseases, clinically significant active cerebrovascular disease, oncologic emergencies requiring urgent intervention, acute or chronic GVHD, or any uncontrolled infections requiring antibiotic therapy, etc., are unsuitable for enrollment.\n7. Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation).\n8. Received allo-HSCT within 6 weeks prior to screening.\n9. Subjects who have recently undergone major surgery or plan to undergo major surgery, excluding diagnostic procedures and biopsies.\n10. Subjects with severe mental disorders, alcoholism, or drug abuse.\n11. Subjects who, in the judgment of the investigator, have other conditions that make them unsuitable for enrollment.","3 Years",{"count":307,"type":20},10,[309],"EARLY_PHASE1","A study to evaluate the safety and preliminary efficacy of CLL-1-targeted CAR-T cell therapy in children aged 3 to 18 years with relapsed or refractory acute myeloid leukemia (r\u002Fr AML).",[29,267],[313,267],"R\u002FR AML","2026-01-05",{"date":316,"type":39},"2026-01-13",{"date":314,"type":20},{"date":319,"type":20},"2028-10-31",{"name":321,"class":46},"First Affiliated Hospital of Guangxi Medical University",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":238,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":344},"100616332","phase-2-post-transplantation-maintenance-therapy-with-cidabenamide-in-patients-with-intermediatehigh-risk-aml-100616332","NCT07304232","Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate\u002FHigh-risk AML","Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate\u002FHigh-risk AML","CM-AML-001","Inclusion Criteria:\n\n1. AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-\u002Fhigh-risk cytogenetic abnormalities at the time of allogeneic transplantation.\n2. Patients must achieve complete remission (CR) post-transplantation.\n3. Enrollment must occur between 60 and 100 days after transplantation.\n4. Age 18 to 75 years.\n5. ECOG performance status 0-1.\n6. Serum creatinine \\\u003C 1.5 × ULN (upper limit of normal).\n7. Serum direct bilirubin \\\u003C 1.5 mg\u002FdL (except in Gilbert's syndrome).\n8. ALT and AST \\\u003C 2.5 × ULN.\n9. Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n1. Receipt of any other investigational drugs post-transplantation.\n2. FLT3 mutation-positive status.\n3. Central nervous system (CNS) involvement.\n4. Uncontrolled grade 2-4 graft-versus-host disease (GVHD).\n5. Uncontrolled active infection.\n6. Known or suspected hypersensitivity to Chidamide or its excipients.\n7. Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.\n8. Pregnancy or breastfeeding.\n9. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.",{"count":331,"type":20},134,[59],"This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation.\n\nTrial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and\u002For consolidation therapy, achieved remission, and underwent stem cell transplantation.\n\nStudy Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).",[335,29],"Allogeneic Hematopoietic Cell Transplantation (HCT)","2025-12-11",{"date":338,"type":39},"2025-12-26",{"date":340,"type":39},"2025-09-01",{"date":205,"type":20},{"name":343,"class":46},"Institute of Hematology & Blood Diseases Hospital, China",5,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":47},"100611157","clinical-study-of-selinexor-based-chemotherapy-with-minimal-or-no-cytotoxic-agents-in-treatment-nave-aml-patients-unsuitable-for-intensive-therapy-focusing-on-rapid-reduction-of-blast-cells-100611157","NCT07236931","Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells","Inclusion Criteria:\n\n1. Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.\n2. Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)\n3. Renal function must meet the following criterion: Creatinine clearance ≥30 mL\u002Fmin calculated using the Cockcroft-Gault formula.\n4. No history of drug allergies within the protocol.\n5. Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.\n6. The participant understands and signs the informed consent form.\n\nExclusion Criteria:\n\n1. A definitive diagnosis of Acute Promyelocytic Leukemia (APL).\n2. Age \\\u003C18 years or ≥75 years.\n3. The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.\n4. Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.\n5. Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.\n6. Patients who have other malignancies that require treatment.\n7. A history of allergy to the study drugs.\n8. Female participants who are pregnant or breastfeeding.\n9. Human immunodeficiency virus (HIV) infection or syphilis infection.\n10. Active hepatitis that remains uncontrolled despite active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid \\[HBV DNA\\] or hepatitis C virus ribonucleic acid \\[HCV RNA\\]).\n11. Patients with persistent positivity for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 (excluding those who have transitioned from positive to negative).\n12. Conditions that the investigator considers may increase the risk to participants or interfere with the study results.\n13. Other conditions that the investigator deems the participant unsuitable for enrollment in this study.","74 Years",{"count":353,"type":20},71,[84],"This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.",[29],"2025-11-14",{"date":359,"type":39},"2025-11-19",{"date":361,"type":20},"2025-11-20",{"date":363,"type":20},"2028-10-20",{"name":297,"class":46},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":372,"sex":16,"minAge":17,"maxAge":238,"enrollmentInfo":373,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":370,"conditions":376,"keywords":378,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":47},"100609398","phase-2-venetoclax--augmented-treosulfan-based-reduced-intensity-conditioning-before-allogeneic-stem-cell-transplantation-100609398","NCT07214064","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation","Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS\u002FAML and Higher Risk MDS","Inclusion Criteria:\n\n1. Age between 18 and 75 years at the time of signing the Informed Consent\n2. Patient is fluent in German\n3. Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial related procedures\n4. Diagnosis of AML,MDS\u002FAML (according to ICC 20226) or HRMDS (IPSS-R7 \\>3.5 or IPSS-M8 \\>0; according to ICC 20226 and IWG 20232)\n5. Myeloid neoplasm (AML, MDS\u002FAML or HR-MDS according to ICC 20226) under control\\* at time of screening, defined as one of the following:\n\n   5.1. AML (ICC 20226):\n\n   • Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after less intensive, HMA-based treatment (up to six cycles) OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after a combination of intensive and less intensive treatments (up to six cycles in total) 5.2. MDS\u002FAML (ICC 20226):• Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria), after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after less intensive, HMA-based treatment (up to six cycles and including HMA monotherapy) OR\n   * Achievement of at least MLFS (according to ELN 20221 criteria) after a combination of intensive and less intensive treatments (up to six cycles in total)• Scheduled for upfront alloHCT:\n   * ≤19% bone marrow blastsAND• ≤19% peripheral blood blastsAND• ≤15.000\u002Fµl peripheral blood Leukocytes 5.3. HR- MDS (ICC 20226, IWG 20232)\n   * Scheduled for alloHCT after prior therapy:\n   * up to six cycles of a less intensive HMAbased treatment or HMA monotherapy AND\n   * ≤9% bone marrow blastsAND• ≤9% peripheral blood blasts• Scheduled for upfront alloHCT:\n   * ≤9% bone marrow blasts AND\n   * ≤9% peripheral blood blasts \\*The disease is considered clinically controlled, when it is either aggressive but has proven responsive to cytostatic chemotherapy (e.g. AML with achievement of at least MLFS) or slowly progressive ( e.g. suitable for upfront alloHCT in cases of MDS\u002FAML) or is both slowly progressive and responsive to therapy\n\n     * a bone marrow assessment is mandatory during screening phase. Patients canonly be enrolled after the according inclusion criteria have been confirmed bybone marrow biopsy. The time window for bone marrow biopsy is day -21 to -14.\n6. Eligiblity for alloHCT according to a board of experienced haematologists\n7. Karnofsky Performance Index ≥60%\n8. Planned alloHCT with Peripheral Blood Stem Cells (PBSC)\n9. Infusion of allogeneic stem cells schedulded between day 14 and day 28 after Screening\n10. Availability of a suitable donor, defind as one of the following:\n\n    10.1. HLA-identical sibling (MSD)OR 10.2. HLA-compatible (9\u002F10 antigens matched for HLA-A, -B, -C, -DRB1, and -DQB1) unrelated donor (MUD) with completed confirmatory typing.\n\n    OR 10.3. Two unrelated donors with \\>90% probability of a 9\u002F10 match for HLA- A, -B, -C, -DRB1, and -DRQB1, according to OptiMatch list (MUD)\n11. Documented diffusion lung capacity for carbon monoxide (DLCO) \\>40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC \\>50%\n12. Left ventricular ejection fraction (LVEF) ≥40%\n13. GFR (CKD-EPI) ≥ 30 ml\u002Fmin\u002F1,73 m2\n14. Bilirubin ≤3x ULN and AST ≤5x ULN\n15. Thoracic imaging (either X-ray or computed tomography (CT)) without evidence of active infection or second malignancy\n16. Subject (male or female) is willing to use highly effective methods during treatment and for 6 months (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). Female participants using homonal contraceptives should use a barrier method as well.1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n17. Absence of pregnancy confirmed by a highly sensitive pregnancy test not older than 3 days at time of screening (only FCBP).\n18. Subject agrees not to share medication.\n\nExclusion Criteria:\n\n1. APL (AML with t(15;17))\n2. MDS\u002FMPN (ICC 20226)\n3. Karnofsky Performance Index \\\u003C60%\n4. Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation\n5. Presence of extramedullary myelosarcoma\n6. Disease Relapse after prior CRc\n7. History of allogeneic hematopoietic stem cell transplantation\n8. Significant active cardiac disease within 6 months prior to the start of study treatment, including:\n\n   * New York Heart Association (NYHA) class III or IV congestive heart failure\n   * Myocardial infarction\n   * Unstable angina\n   * Cerebral apoplexy\n   * Severe cardiac arrhythmias\n   * Left ventricular ejection fraction (LVEF) \\\u003C40% by TTE\n9. Documented diffusion lung capacity for carbon monoxide (DLCO) ≤40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC ≤50%\n10. GFR (CKD-EPI) \\\u003C30 ml\u002Fmin\u002F1,73 m2\n11. Bilirubin \\>3x ULN or AST \\>5x ULN\n12. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.\n13. Active viral infection, including hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial. An infection controlled with an approved antiviral treatment is allowed.\n14. Presence of Proven, Probable or Possible Invasive Fungal Disease (IFD) as defined by EORTC\u002FMSG 20209 Definitions (please consult Appendix)\n15. Serologies suggestive of recent (\\\u003C6 months) infection or reactivation with\u002Fof Toxoplasma gondii (based on IgG, IgM and Avidity) or of infection with Treponema pallidum (based on TPPA).\n16. Any clinically uncontrolled infection (bacterial or unknown pathogen), defined as persisting or recurring fever or rising levels of CRP (≥10 mg\u002Fdl) despite intravenous antibacterial or antifungal therapy (initiated or escalated at least 72h hours ago)\n17. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation.\n18. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n19. Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n\n    * Basal or squamous cell carcinoma of the skin;\n    * Carcinoma in situ of the cervix;\n    * Carcinoma in situ of the breast;\n    * Incidental histologic finding of prostate cancer.\n20. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patients, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy)\n21. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n22. Women during pregnancy and lactation.\n23. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.\n24. Participation in other trials interfering with the endpoint of this study. Prior trial participation is permitted, provided that treatment with the investigational medicinal product has been completed at least 4 days prior to screening for this trial (at least 10 days before planned study treatment).",true,{"count":374,"type":20},27,[59],[29,377,87],"MDS\u002FAML",[379,196,380,381],"Allogeneic Stem Cell Transplantation","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning","RIC","2025-10-02",{"date":384,"type":39},"2025-10-09",{"date":386,"type":20},"2026-01",{"date":388,"type":20},"2027-12",{"name":390,"class":46},"University Hospital Tuebingen",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":399,"targetDuration":401,"studyType":218,"phases":4,"briefSummary":402,"conditions":403,"keywords":407,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":47},"100604004","prognostic-impacts-of-lipid-profile-and-bmi-in-adult-aml-100604004","NCT07143877","Prognostic Impacts of Lipid Profile and BMI in Adult AML","Prognostic Impacts of Lipid Profile and Body Mass Index in Adult Acute Myeloid Leukemia Patients Treated With Intensive Induction Chemotherapy","AML\u002FBMI","Inclusion Criteria:\n\n* Adult patients (≥18yearsold) newly diagnosed with AML.\n* Patients eligible for intensive induction chemotherapy.\n* Patients who have given informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with secondary or relapsed AML.\n* Patients currently using lipid-lowering medications (e.g., statins).\n* Patients with known endocrine or metabolic disorders affecting BMI or lipid profile (e.g., uncontrolled diabetes, hypothyroidism, Cushing's syndrome).\n* Pregnant or lactating women.\n* Patients unwilling or unable to complete the study protocol.\n* Patients with M3 subtype of AML.",{"count":400,"type":20},200,"35 Days","The goal of this observational study is to evaluate the changes in lipid profile parameters (total cholesterol, triglycerides, HDL-C, and LDL-C) in adult AML patients before and after intensive induction chemotherapy. The main questions it aims to answer are:\n\n* Are there correlations between metabolic changes (in lipid profile and BMI) and treatment outcomes, including remission status and incidence of chemotherapy-related complications?\n* Can the baseline lipid profile and BMI serve as prognostic markers for response to induction chemotherapy.?\n\nParticipants will be observed before and after induction chemotherapy regarding their lipid profile, and BMI, observing any correlations between the different results with any complications, and with remission status.",[29,404,405,406],"BMI","Lipid Profile","Induction Chemotherapy",[31,404,408,409,410],"Lipid profile","Adult","Induction chemotherapy","2025-08-23",{"date":413,"type":39},"2025-08-27",{"date":415,"type":20},"2025-11-15",{"date":417,"type":20},"2027-03-15",{"name":419,"class":46},"Assiut University",{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":238,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":47},"100569175","phase-1-clinical-trial-of-cd123-targeted-car-nk-therapy-for-relapserefractory-aml-or-bpdcn-100569175","NCT06690827","Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse\u002Frefractory AML or BPDCN","Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse\u002Frefractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)","Inclusion Criteria:\n\n1. Patients of any gender, aged between 18 and 75 years (inclusive);\n2. Positive expression of CD123 on tumor cells detected by flow cytometry;\n3. Patients with a confirmed diagnosis of CD123-positive relapsed\u002Frefractory AML or BPDCN:\n\n(1) For AML patients：\n\n* Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;\n* Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation\u002Fintensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;\n\n  (2) For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites.\n\n  4\\. Expected survival time of more than 12 weeks;\n\n  5\\. ECOG score of 0-2 (Appendix 2);\n\n  6\\. No severe mental disorders;\n\n  7\\. Basic normal function of important organs:\n  1. Blood routine: white blood cells \\>1.0×109\u002FL, neutrophils \\>0.5×109\u002FL, lymphocytes \\>0.5×109\u002FL, platelets \\>50×109\u002FL;\n  2. Cardiac function: echocardiography indicates a left ventricular ejection fraction ≥50%, and no significant abnormalities on electrocardiogram;\n  3. Renal function: serum creatinine ≤2.0×ULN;\n  4. Liver function: ALT and AST ≤3.0×ULN (for patients with liver invasion\n\n     * 5.0×ULN);\n  5. Total bilirubin ≤2.0×ULN (for patients with Gilbert's syndrome ≤3.0×ULN);\n  6. Blood oxygen saturation \\>92%. 8. The patient or their legal guardian agrees to participate in this clinical trial and signs the ICF, indicating their understanding of the purpose and procedures of the clinical trial and willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Presence of active central nervous system invasion during screening;\n2. Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who have confirmed disease progression after treatment;\n3. Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;\n4. Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;\n5. Presence of any of the following cardiac diseases:\n\n   1. Congestive heart failure at New York Heart Association (NYHA) class III or IV;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n6. Combination with active autoimmune diseases requiring long-term immunosuppressive therapy;\n7. Presence of other malignancies, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.\n8. Receipt of live attenuated vaccines within 4 weeks prior to screening;\n9. Pregnant or breastfeeding women, as well as male or female subjects who plan to have children within 1 year after receiving CAR-NK cell infusion;\n10. Other conditions that the investigator deems unsuitable for participation in the study.",{"count":428,"type":20},30,[23],"This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed\u002Frefractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.",[29,432],"BPDCN (blastic Plasmacytoid Dendritic Cell Neoplasm)",[434,31,435,436,437,438,439,440,441],"CD123","Acute Myeloid Leukemia","blastic plasmacytoid dendritic cell neoplasm","acute leukemia","Malignant Hematoma","CAR-NK","CD123 CAR-NK","Chimeric antigen natural killer cells","2024-11-13",{"date":444,"type":39},"2024-11-15",{"date":442,"type":20},{"date":447,"type":20},"2028-10-30",{"name":449,"class":132},"Chongqing Precision Biotech Co., Ltd"]