[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloid-leukemia-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloid-leukemia-acute":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,62,75,106,133,159,181,210],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100053414","phase-1-autologous-t-cells-transduced-with-retroviral-vectors-expressing-tcrs-for-participant-specific-neoantigens-in-patients-with-hematologic-malignancies-100053414",false,"NCT06904066","Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies","A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies","* INCLUSION CRITERIA:\n\nMalignancy diagnosis requirements:\n\n-Eligible diagnoses include AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), CMML(chronic myelomonocytic leukemia), CML (chronic myeloid leukemia), and T-ALL (T-acute lymphoblastic leukemia\u002Flymphoma) meeting standard diagnostic criteria as described in the 5th edition World Health Organization Classification of Hematologic Tumors and\u002For the International Consensus Classification of Myeloid Neoplasms and Acute Leukemias. Multiple myeloma participants meeting International Working Group diagnostic criteria are eligible. These diagnostic criteria can be met at any time during the course of the participant s malignancy. Atypical CML is not an eligible diagnosis.\n\nNOTE: Pathology reports are acceptable to confirm eligibility.\n\nMalignancy mutation and HLA requirements:\n\n* Detection of at least one of the neoepitope-forming TP53 or RAS mutations that are listed in Table 3 in on the TruSight Oncology (TSO) 500 sequencing panel (NSR device) performed in the NCI Laboratory of Pathology is required. RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the location of the targeted neoepitopes. A variant allele frequency (VAF) of at least 5% is required for a mutation to be eligible. This criterion can be met at any time within 60 days prior to apheresis regardless of treatment history during this 60-day period. DNA for sequencing comes from bone marrow.\n* Presence of the correct HLA type needed to present one of the targeted neoepitopes as shown in Table 3. HLA typing data from any time-point prior to apheresis can be used to meet this requirement.\n\nTable 3: Eligibility requirements for the targeted mutation and HLA type\n\nTargeted mutation - TP53 R175H; HLA Type - A\\*02:01\n\nTargeted mutation - TP53 Y220C; HLA Type - A\\*02:01\n\nTargeted mutation - TP53 R248W; HLA Type - A\\*68:01\n\nTargeted mutation - Ras G12V; HLA Type - A\\*11:01\n\nTargeted mutation - Ras G12D; HLA Type - A\\*11:01\n\nTargeted mutation - Ras G12D; HLA Type - C\\*08:02\n\nTargeted mutation - Ras G12V; HLA Type - C\\*01:02\n\nMalignancy burden requirements:\n\n* For AML and MDS, bone marrow myeloblast percentage must be \\>=5% of nucleated cells in either bone marrow aspirate or biopsy. Myeloblasts can be defined by immunohistochemistry or by cytochemistry stains including but not limited to myeloperoxidase.\n* For T-ALL, bone marrow T-cell blast percentage must be \\>=5% of nucleated cells in either bone marrow aspirate or biopsy. T cells can be defined by cytochemistry or immunohistochemistry or flow cytometry.\n* For multiple myeloma, plasma cells having a phenotype consistent with multiple myeloma must be detected at any frequency by multiparameter bone marrow flow cytometry or total plasma cells must be at least 6% on bone marrow core biopsy or bone marrow aspirate.\n* For CMML, bone marrow blast (including monocytic blast equivalent) percentage must be \\>=6% of bone marrow nucleated cells by cytochemistry or immunohistochemistry of bone marrow aspirate or biopsy.\n* For CML measurable leukemia is defined as molecular detection of BCR-ABL1 at a ratio of \\>1.0% to ABL1 or another housekeeping gene on The International Scale (IS) in either blood or bone marrow.\n\nMalignancy prior treatment and risk category criteria\n\n\\- Participants with AML, MDS, CML, CMML, and T-ALL who have not had prior allogeneic hematopoietic stem cell transplantation (alloHSCT) must be unwilling or unable to undergo alloHSCT.\n\nNOTE: Unable to undergo alloHSCT could be due to lack of access to transplantation or not meeting transplant eligibility criteria at one or more transplant centers where the participant was evaluated by a transplant physician.\n\n* Participants with primary, secondary, or treatment-related AML that did not go into remission after induction therapy are eligible regardless of history of alloHSCT.\n* Myelodysplastic syndrome (MDS)\n\n  * Participants with MDS must have had high or very high risk MDS as determined by IPSS-R or IPSS-M (https:\u002F\u002Fmds-risk-model.com) at any time point.\n  * Participants with MDS must have received previous treatment with at least one of the following: a hypomethylating agent, cytotoxic chemotherapy, or alloHSCT. Participants with primary or treatment-related MDS are eligible.\n  * Participants with MDS\u002FAML with mutated TP53 are eligible.\n* Participants with CMML must have had a CMML-specific prognostic scoring system-Molecular (CPSS-Mol) score of \\>=2 (Intermediate-2 or High risk groups) at any time-point and must have received at least one line of previous systemic treatment, which could have been alloHSCT.\n* Chronic myeloid leukemia (CML)\n\n  * Participants with chronic phase CML and a history of inadequate response to or intolerance of 3 or more tyrosine kinase inhibitors (TKIs) are eligible.\n  * In addition, participants who have received at least one of bosutinib, dasatinib, or nilotinib in addition to either ponatinib or asciminib are eligible. Participants in accelerated phase or blast crisis are eligible if they have received at least one TKI.\n  * Participants who have received a prior HSCT are eligible provided they have also received at least 2 TKIs and meet other eligibility criteria.\n* Participants with T-ALL must have T-ALL that did not go into CR with induction therapy or that relapsed.\n* Participants with relapsed AML who are unable to undergo alloHSCT and meet other eligibility requirements are eligible.\n* Multiple Myeloma\n\n  * Participants with multiple myeloma must have received at least 3 different prior systemic treatment regimens for multiple myeloma. Participants must have prior exposure to an imid such as lenalidomide, a proteosome inhibitor, and a BCMA-targeting CAR T-cell therapy, such as monoclonal antibody, or bispecific antibody.\n  * Multiple myeloma participants with a history of alloHSCT are eligible\n  * Participants with multiple myeloma must also have measurable multiple myeloma\n\ndefined by at least one of the criteria below:\n\n* Serum M-protein greater or equal to 1.0 g\u002FdL.\n* Urine M-protein greater or equal to 200 mg\u002F24 h.\n* Serum free light chain (FLC) assay: involved FLC level greater or equal to 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n* A biopsy-proven plasmacytoma at least 2.0 cm in largest dimension.\n* Bone marrow core biopsy with 30% or more plasma cells.\n\nOther inclusion criteria\n\n* Blast cells \\\u003C=1% of white blood cells as measured by CBC and differential before apheresis\n* Plasma cells \\\u003C=1% of white blood cells as measured by CBC and differential before apheresis\n* Participants must be willing to undergo intensive care unit care including mechanical ventilation if necessary\n* Participants must not have received systemic chemotherapy for at least 14 days prior to start of lymphodepleting chemotherapy or apheresis, and chemotherapy-related toxicities other than cytopenias must have recovered to grade 0 or grade 1 by the time of apheresis. The one exception is if necessary to control AML, CML, or CMML, hydroxyurea can be administered up to 7 days prior to apheresis.\n* Participants who have received alloHSCT must have received a transplant from either a fully matched sibling or 10\u002F10 HLA-matched unrelated donor.\n* Recipients of alloHSCT must be at least 100 days post-transplant before the apheresis.\n* Subjects must be willing to be co-enrolled on NCI protocol 03C0277 and 09C0161.\n* Age must be \\>=18 and \\\u003C= 75 years old\n* Clinical performance status of ECOG 0 or 1\n* Participants must have adequate organ function as defined below:\n\n  * Hemoglobin: \\>=8 g\u002FdL without red blood cell transfusions for 7 days prior to blood count check\n  * Platelets: \\>=45,000\u002FmcL without transfusion support in the 7 days prior to the blood count check\n  * Absolute neutrophil count: \\>=850\u002FmcL without exogenous growth factor administration within the 10 days prior to the blood count check\n  * Total bilirubin: \\\u003C= 2.0 mg\u002FdL. Except for participants with Gilbert s syndrome (who must have a total bilirubin \\\u003C3 mg\u002FdL)\n  * Alanine transaminase (ALT) and aspartate transaminase (AST): \\\u003C= to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST must be \\\u003C= 5 times the upper limit of normal\n  * Serum Creatinine: \\\u003C= 1.5 mg\u002FdL\n* Participants who have received prior genetically-engineered T-cell therapies are eligible if at least 180 days have elapsed between the date of previous T-cell infusion and apheresis.\n* Room air oxygen saturation must be 93% or greater\n* Women of child-bearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy. NOTE: IOCBP is defined as any person who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\nMen able to father children must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and for 4 months after the last dose of combined chemotherapy. We also will recommend these Men with partners of childbearing potential ask their partners to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Men able to father a child must not freeze or donate sperm within the same period.\n\n* Nursing participants must be willing to discontinue breastfeeding from study treatment initiation through 4 months after the last dose of the study drug(s).\n* Hepatitis B surface antigen and hepatitis B core antibody tests must be negative. If either of these tests are positive, participants must have a negative blood PCR test for hepatitis B to enroll on the study.\n* Hepatitis C antibody test must be negative. If this test is positive, participants must have a negative blood PCR test for hepatitis C RNA to enroll on the study.\n* Cardiac ejection fraction of greater than or equal to 50% by echocardiography with no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 30 days prior to apheresis.\n* All participants must be willing to undergo mandatory bone marrow biopsy\u002F aspirates during the study.\n* Participants with a history of cigarette smoking of \\>5 pack years, a history of pulmonary disease, a history of alloHSCT, or chronic pulmonary symptoms must undergo pulmonary function testing and have an FEV1 \\>50% predicted and diffusing capacity for carbon monoxide \\>= 60%.\n* Subjects who received a previous allogeneic HSCT must have no (grade 0) acute GVHD and no chronic GVHD or mild chronic GVHD as defined.\n\n  --NOTE: Subjects with GVHD meeting the above criteria with local therapy (topical cutaneous steroids, inhaled steroids, and eye drops) will be eligible.\n* Potential participants must agree to stay within 1-hour drive of NIH clinical center from date of initial discharge until at least 14 days have elapsed since T cell infusion through the 14 day time period.\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n\nEXCLUSION CRITERIA:\n\n-For alloHSCT recipients only, subjects receiving any systemic immunosuppressive drugs including corticosteroids at doses of greater than 5 mg\u002Fday prednisone or equivalent within 28 days prior to apheresis.\n\nNOTE: Topical corticosteroid preparations applied to the skin such as solutions, creams, and ointments are allowed. Inhaled corticosteroids are allowed, and corticosteroid eye drops are allowed.\n\n* Corticosteroids given for any indication at doses greater than 5 mg\u002Fday of prednisone or equivalent within 14 days before either apheresis or start of protocol chemotherapy.\n* Participants with MDS\u002FMyeloproliferative neoplasia overlap syndromes are not eligible.\n* Participants with acute promyelocytic leukemia are not eligible.\n* Participants who received a mis-matched sibling or haploidentical transplant are not eligible.\n* Tumor masses \\>=10 cm in largest diameter\n* Positive beta Human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP performed at screening.\n* Human T-cell lymphotropic virus type 1\u002F 2 (HTLV-1\u002FII) positive\n* HIV infection, as measured by seropositivity for HIV antibody.\n* Participants that require urgent therapy due to tumor mass effects on vital organ or tumor lysis syndrome.\n* Any significant illness that, in the opinion of the principal investigator, may impair the participant s tolerance of the study treatment as evaluated by medical history, physical exam, assess for hepatosplenomegaly, and chemistry laboratory evaluations.\n* Participants with a history of a previous malignancy are ineligible if the malignancy has not been in complete remission for at least 2 years or if the previous malignancy required treatment with surgery, radiation, or chemotherapy, including maintenance hormonal therapy, in the past 2 years. Exceptions to this requirement are participants who have had successful resection of the following types of skin cancer: nonmetastatic basal cell carcinoma or squamous cell carcinoma or stage 0 melanoma.\n* Suspected or confirmed active uncontrolled infections defined as fevers of \\>38 degrees within the past 24 hours without a known non-infectious source or participants requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours.\n* Acti...","ALL","18 Years","120 Years",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nBlood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes.\n\nObjective:\n\nTo test the use of neoepitope-specific T cells in people with blood cancers\n\nEligibility:\n\nPeople aged 18 to 75 years with any of 9 blood cancers.\n\nDesign:\n\nParticipants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue.\n\nParticipants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nThe T cells will be grown to become neoepitope-specific T cells.\n\nParticipants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment.\n\nParticipants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.",[27,28,29,30,31,32,33,34,35,36,37],"Malignancy, Hematologic","Neoplasms, Hematologic","Neoplasms, Hematopoietic","Blood Cancer","Hematological Neoplasms","Hematopoietic Malignancies","Dysmyelopoietic Syndromes","Hematopoetic Myelodysplasia","Myeloid Leukemia, Acute","Nonlymphoblastic Leukemia, Acute","Leukemia, Lymphocytic, Acute",[39,40,41,42,43,44,45,46,47,48],"Chronic Myelomonocytic Leukemia","Multiple Myeloma","Tumor-Associated Antigen","T-cell acute lymphoblastic leukemia","T cell immunotherapy","Myelodysplastic Syndrome","Hematologic Malignancies","Engineered T cell receptor","Chronic Myeloid Leukemia","Adoptive T Cell Therapy","RECRUITING","2026-07-10",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":21},"2026-07-16",{"date":57,"type":21},"2029-04-30",{"name":59,"class":60},"National Cancer Institute (NCI)","NIH",1,{"id":63,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":25,"conditions":66,"keywords":67,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":61},"100585569",{"count":20,"type":21},[24],[27,28,29,30,31,32,33,34,35,36,37],[39,40,41,42,43,44,45,46,47,48],"2026-07-01",{"date":70,"type":53},"2026-07-02",{"date":72,"type":21},"2026-07-07",{"date":57,"type":21},{"name":59,"class":60},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100569696","a-decisional-intervention-for-older-adults-with-acute-myeloid-leukemia-and-their-caregivers-100569696","NCT06697600","A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers","UR-GOAL RCT","Patients\n\nInclusion criteria:\n\n* Age ≥60 years (from date of consent, confirmed on electronic medical records)\n* A new diagnosis of AML\n\n  * Diagnosis can be based on the International Consensus Classification or World Health Organization\n  * Myeloid sarcoma is allowed\n  * AML with central nervous system involvement is allowed\n* Cancer-directed treatment has not started\n\n  * Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine\n  * Intrathecal chemotherapy is acceptable\n* The patient's oncologist has been or will be enrolled on the study\n* English or Spanish-speaking\n* Patients without a caregiver will still be eligible to participate in the study Exclusion criteria\n* A diagnosis of acute promyelocytic leukemia\n* Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures\n* Prior cancer-directed treatment for AML\n\nCaregivers\n\nInclusion criteria:\n\n* Selected by the patient when asked if there is a \"family member, partner, friend or caregiver \\[age 18 or older\\] with whom you discuss or who can be helpful in healthrelated matters.\"\n* Caregiver may be paid\u002Fprofessional or informal caregiver\n* Able to provide informed consent\n* English or Spanish-speaking\n\nOncologists\n\nInclusion criteria:\n\n• Oncologists caring for patients with AML Exclusion criteria","60 Years",{"count":84,"type":21},1020,[86],"NA","This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \\[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\\] compared to an attention control.",[89,35,90],"Oncology","Cancer",[92,93,94],"older adults","geriatric oncology","caregivers","2026-03-29",{"date":97,"type":53},"2026-03-31",{"date":99,"type":53},"2025-07-11",{"date":101,"type":21},"2030-06-01",{"name":103,"class":104},"University of Rochester","OTHER",4,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":61},"100414575","phase-1-is-free-treg-haplohct-100414575","NCT04678401","IS-free Treg HaploHCT","A Pilot\u002FPhase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in Relapsed\u002FRefractory and Ultra-High-risk AML\u002FMDS","Inclusion Criteria:\n\n* Cohort A: Histologically confirmed disease in the prior 4 weeks, despite at least 1 prior line of therapy (e.g., 3+7 chemotherapy, HMA therapy): Rel\u002Fref AML (de novo or secondary) with ≥5% blasts in BM (or extramedullary sites); MDS EB-2 (BM ≥10% blasts, PB 5-19% blasts).\n* Cohort B: Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with mutated TP53' per 2022 International Consensus Classification (Appendix L) regardless of response\n* Cohort C: Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with multi-hit or complex karyotype (CK+) mutated TP53' per 2022 International Consensus Classification (Appendix L) with response: AML (de novo or secondary) with \\\u003C5% blasts in BM; MDS with \\\u003C10% blasts in BM or PB.\n* Available haploidentical HLA-matched (-A, -B, -C, -DRB1) related donor aged 18-65 years.\n* Age ≥18 to 65 years for Cohort A and B. Age ≥18 to 75 years for Cohort C. Because no dosing or adverse event data are currently available on the use of IS-free haploHCT in participants \\\u003C18 years of age, children are excluded from this study but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60, see Appendix A).\n* Adequate organ and marrow function as defined below:\n\n  * Pulmonary Function: FEV1, FVC and DLCO ≥ 60% of predicted (corrected for hemoglobin)\n  * Cardiac Ejection Fraction ≥ 45%, and no evidence of pulmonary hypertension\n  * Hepatic: Total bilirubin within normal institutional limits (exception permitted in Gilbert's Syndrome after discussion with study PI, on a case-by-case basis); and AST (SGOT)\u002FALT (SGPT) \\\u003C2x institutional upper limit of normal\n  * Renal: Serum Creatinine within normal institutional limits or creatinine clearance \\>50 mL\u002Fmin\u002F1.73 m2 (see Appendix B) for participants with creatinine levels above institutional normal.\n* The effects of IS-free haploHCT on the developing human fetus are unknown. For this reason and because radiation and chemotherapeutic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and a minimum of 4 months after completion of study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had cytotoxic chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or mitomycin C) prior to entering the study. Use of hydroxyurea, HMA, e.g., azacytidine, decitabine) and\u002For FDA-approved novel targeted agents (e.g., venetoclax, FLT-3 inhibitors, IDH 1\u002F2 inhibitors) are permitted up to a day prior to start of HCT conditioning.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual non-hematologic toxicities \\> Grade 1) with exception of alopecia, unless cleared by study PI.\n* Participants who received Mylotarg or other therapies associated with increased risk of hepatic veno-occlusive disease (VOD) or have known prior or active VOD. All novel therapies will be reviewed with PI.\n* Participants who are receiving any other investigational agents within 21 days (or 5 half-lives) prior to study entry, whichever is longer, unless cleared by the study PI.\n* Participants with extramedullary disease at immune privileged sites (e.g., CNS, testes, eye) are excluded, as these sites are less susceptible to the curative graft vs. leukemia effect of HCT.\n* Myocardial infarction within 2 years prior to enrollment.\n* Venous thromboembolic event (VTE) of DVT\u002F PE within 1 year prior to enrollment, unless approved by study PI. Patients with line-associated DVT within the past year may be enrolled if they have completed anticoagulation therapy.\n* Stroke or transient ischemic attack (TIA) within 1 year prior to enrollment.\n* History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation or clinically significant gastrointestinal (GI) hemorrhage or hemoptysis within the prior 6 months.\n* Patients with a history of thrombotic microangiopathy (TMA) or hemolytic uremic syndrome\u002Fthrombotic thrombocytopenic purpura (HUS\u002FTTP).\n* History of life-threatening reactions to iron infusions or murine antibody-containing products.\n* Known donor-specific antibodies (DSA) in the recipient of clinical significance (e.g., requiring DSA depletion with plasmapheresis, rituximab) are excluded.\n* Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes involved in cyclophosphamide and\u002For thiotepa metabolism (see Section 5.5) during day -10 through day -5. It is acceptable use alternative non-interacting medications during this period, and then restart prior medications\n* Participants with uncontrolled bacterial, viral or fungal infections (i.e., currently taking medications with progression of clinical symptoms or signs).\n* Recipients of prior allogeneic or autologous hematopoietic cell transplantation, or solid organ transplantation.\n* Prior radiation exposure or other medical condition (e.g., Fanconi syndrome) that precludes use of myeloablative radiation (TMLI).\n* HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the multiple agents used routinely in myeloablative allogeneic stem cell transplantation. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.\n* Participants seropositive for hepatitis B or C infection are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after myeloablative HCT.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because radiation and conditioning chemotherapy has the potential for teratogenic or abortifacient effects. A negative pregnancy test is required for females of childbearing potential. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IS-free haploHCT breastfeeding should be discontinued if the mother is treated with IS-free haploHCT.\n* Participants with a history of another non-hematologic malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.","75 Years",{"count":115,"type":21},30,[24],"This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed\u002Frefractory and Ultra-high risk acute myeloid leukemia (AML) and\u002For myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT).\n\nThe names of the study interventions involved in this study are:\n\n* Radiation-Total Myeloid and Lymphoid Irradiation (TMLI)\n* Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna)\n* Infusion of haplo Treg-enriched donor cells (experimental therapy)\n* Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells)\n* Infusion of haplo donor CD34+ Peripheral Blood Stem Cells",[119,120,35,121,122],"Stem Cell Transplant Complications","Graft Vs Host Disease","Myeloid Leukemia in Relapse (Disorder)","Myelodysplastic Syndromes",[119,120,35,121,122],"2025-10-16",{"date":126,"type":53},"2025-10-20",{"date":128,"type":53},"2021-01-12",{"date":130,"type":21},"2029-08-31",{"name":132,"class":104},"Dana-Farber Cancer Institute",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":142,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":61},"100574836","molecular-characterization-of-patients-with-acute-myeloid-leukemia-and-the-impact-of-clonal-evolution-in-the-response-to-therapeutic-treatments-100574836","NCT06764459","Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments","CLEV-LAM-2022","Inclusion Criteria:\n\n* FLT3 mutated\n\nExclusion Criteria:\n\n* Respoder to therapy",{"count":141,"type":21},20,"3 Years","OBSERVATIONAL","This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.",[35],[147,148,149],"AML","FLT3","single cell sequencing","2025-01-29",{"date":152,"type":53},"2025-01-30",{"date":154,"type":53},"2023-03-15",{"date":156,"type":21},"2026-12-31",{"name":158,"class":104},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":5},"100564262","integrative-omics-approaches-for-leukemia-target-identification-and-matched-therapeutic-intervention-100564262","NCT06626893","Integrative \"Omics\" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention","AL-TOMICA","Inclusion Criteria:\n\n* Patients to be enrolled in the study must have a diagnosis of AML, B ALL\u002FLBL, T ALL\u002FLBL, MPAL\u002FAUL as described by WHO 2016 classification and must complained relapsed or refractory disease after at least one line of therapy\n* Ages Eligible for Study: over 18years\n* Patients must have greater than 5% blasts in the bone marrow with or without extramedullary disease\n* Patients with must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis\n* Patients may be enrolled on study regardless of the timing of prior I therapy\n* Patients must be capable of understanding the investigational nature and the objectives of the study. All patients must sign a written informed consent.\n\nExclusion Criteria:\n\n\\-",{"count":167,"type":21},100,[86],"The goal of this clinical trial is to use multiple \"omics\" sciences to more thoroughly investigate Acute Recurrent\u002FRefractory Leukemias (LA R\u002FR) after conventional therapy in order to identify new targets and\u002For therapeutic approaches, in patients with a diagnosis of Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia\u002F Lymphoblastic Lymphoma B(ALL-B), Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma T (ALL-T), Acute Biphenotypic Leukemia\u002FII as defined by WHO( World Health Organization) 2016, relapsed or refractory after at least one line of therapy. The main question that the trial aims to answer is: \"Can molecules with known biological activity be active and represent possible new therapeutic strategies in relapsed\u002Frefractory Acute Leukemias on the basis of response profiles identified through the integration of next-generation chemogenomic and functional analyses? \" It is expected that a minimum of 100 patients, male and female, aged 18 years and older, will be included. To participate in the study, the patient must consent to the performance on biological specimen (peripheral blood and bone marrow) of genetic\u002Fmolecular and\u002For \"omics\" investigations performed with modern sequencing techniques, such as Next Generation Sequencing, Single Cell RNA Seq (scRNAseq), RT-qPCR(Quantitative reverse transcription polymerase chain reaction). These investigations will aim to improve the understanding of the genetic and molecular alterations of her disease. In addition, your cells will be used in the laboratory to perform in vitro sensitivity studies (drug response profiling - DRP) that aim to simultaneously test a set of hundreds of drugs to assess sensitivity or resistance profiles of your disease cells with the aim of identifying specific new therapies that target specific cellular mechanisms. In addition, part of the biological sample will be used for investigations of the bone marrow microenvironment and the \"secretome\", i.e., cell signaling molecules and methods. In order to accomplish this study, samples from peripheral or bone marrow blood taken during routine investigations performed during follow-up and re-evaluation visits for the patient's disease as per normal clinical practice will be used. Among the investigations that will be performed on the blood sample will be the genetic\u002Fmolecular and\u002For omics and preclinical investigations described above.",[35,171],"Leukemia, Acute Lymphoblastic","2024-10-02",{"date":174,"type":53},"2024-10-04",{"date":176,"type":53},"2022-03-01",{"date":178,"type":21},"2025-03-01",{"name":180,"class":104},"Azienda Ospedaliero-Universitaria di Parma",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":194,"conditions":195,"keywords":196,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":61},"100562115","phase-2-tmli-plus-chemotherapy-in-high-risk-myelodysplastic-syndrome-or-acute-myeloid-leukemia-100562115","NCT06598969","TMLI Plus Chemotherapy in High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia","Phase II Study of TMLI Administered in Combination With a Myeloablative Regimen (Cyclophosphamide + Etoposide) for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia","TMLI-MA","Inclusion Criteria:\n\n* The participant has the ability and willingness to sign the informed consent document\n* Age ≥18 to ≤50 years.\n* Karnofsky's performance status should be ≥70%.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or acute myeloid leukemia with relapsed\u002Frefractory active disease, or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing\n* All candidates for this study must have an Human leukocyte antigens (A, B, C, DR) identical siblings who are willing to donate bone marrow or peripheral blood hematopoietic progenitors or an 8\u002F8 matched unrelated donor. A single allele mismatch in A, B, C or DR beta chain 1 shall be allowed\n* Total bilirubin ≤ 1.5 x upper limit of normal or 3 x upper limit of normal for Gilbert's disease.\n* serum glutamate oxaloacetate transaminase \\& serum glutamate pyruvate transaminaseT ≤ 5 x upper limit of normal.\n* Serum creatinine ≤ 1.3 mg\u002FdL or creatinine clearance measured ≥ 80 mL\u002Fmin for 24 hours of urine collection\n* Women of childbearing age only: Negative urine or serum pregnancy test\n* Pulmonary function tests: forced expiratory volume in one second and Carbon Monoxide Diffusion Capacity (adjusted for Hb) ≥ 50% from expected normal value\n* Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by Multi-Gated Acquisition Scan or echocardiogram\n* Men and women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation\n* The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days\n\nExclusion Criteria:\n\n* Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded\n* Previous radiation therapy, which would preclude the use of total bone marrow and lymphoid irradiation\n* Plans during the trial to receive any other investigational (non-trial-related) agents\n* Uncontrolled disease, including ongoing or active infection\n* History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide\n* Patients with other active malignancies are not eligible for this study, other than the malignancies discussed\n* Patients with a psychological or medical condition that the patient's physician deems unacceptable to proceed with allogeneic hematopoietic stem cell transplantation\n* Women who plan to become pregnant or breastfeed during the trial\n* Patients who do not agree to practice effective forms of contraception\n* Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study","50 Years",{"count":191,"type":21},58,[193],"PHASE2","Single-arm, single-center phase II trial to evaluate the antileukemic activity and safety\u002Ftolerability of TMLI\u002Fcyclophosphamide and etoposide conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia.",[122,35],[197,198,199],"High-Risk myelodysplastic syndrome","Acute myeloid leukemia","Total narrow and lymphoid irradiation","NOT_YET_RECRUITING","2024-09-16",{"date":203,"type":53},"2024-09-19",{"date":205,"type":21},"2024-12-30",{"date":207,"type":21},"2028-12-30",{"name":209,"class":104},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":105},"100451632","impact-of-allo-hsct-on-bone-remodeling-evolution-of-bone-mineral-density-and-architecture-measured-by-bone-densitometry-100451632","NCT05161026","Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry","Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry Coupled With FRAX \u002F TBS in Allo-HSCT","REMODALLO","Inclusion Criteria:\n\n* Cytological diagnosis of acute myeloid leukemia (AML) with indication for a first-line allo-HSCTs transplant\n* Patient affiliated to the social security system\n* For women of childbearing age, use of reliable contraception throughout the study in accordance with the CPR of the drugs used.\n* The patient must be able to comply with study visits and per protocol procedures\n* Patient who has been informed of the study and has signed his informed consent\n\nExclusion Criteria:\n\n* Person under guardianship or curatorship, or unable to understand the purpose of the study.\n* Hematologic malignancies other than AML\n* History of neoplasia with bone involvement (sarcoma, multiple myeloma, metastasis...) and\u002For any solid cancer less than 5 years old\n* History of fracture of the femoral neck prior to the diagnosis of hematologic malignancies\n* Known bone involvement related to AML at diagnosis\n* Primary or secondary osteoporosis known to the diagnosis of hematologic malignancies\n* Corticotherapy \\> 3 months at a dose \\> 7.5mg\u002Fday prior to the diagnosis of hematological disease\n* Autograft or anterior allograft\n* Pathologies influencing bone metabolism: known inflammatory rheumatism (rheumatoid arthritis, ...), primary hyperparathyroidism, chronic renal failure (GFR \\\u003C or = at 30ml \u002F min \u002F 1.73m2)\n* Pregnant or lactating woman",{"count":219,"type":21},120,[86],"Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.",[35],[224,225],"allo-HSCTs transplant","osteoporosis","2021-12-06",{"date":228,"type":53},"2021-12-16",{"date":230,"type":21},"2021-12-10",{"date":232,"type":21},"2027-12-01",{"name":234,"class":104},"University Hospital, Caen"]