[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-lymphocytic-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-lymphocytic-acute":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,62,75,110,136],{"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":80,"acronym":4,"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":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100438382","phase-1-a-phase-12-study-of-enzomenib-dsp-5336-in-patients-with-acute-leukemia-horizen-1-100438382","NCT04988555","A Phase 1\u002F2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Expansion Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation (Horizen-1)","Inclusion Criteria:\n\nFor patients in Phase I:\n\n1. Have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage according to World Health Organization (WHO) 2022 classification, or, in selected sites and regions, a diagnosis of MDS or MM as determined by pathology review at the treating institution, and whose disease has progressed after available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage or, in selected sites and regions, for MM or MDS. If acute leukemia patients are transformation from MDS or other hematologic malignancies, patients need to receive available standard therapies as acute leukemia after AML transformation and before enrolling this trial. In regions or countries where required by regulatory authorities, participants must have a documented KMT2A (MLL) fusion or NPM1 mutation, including those with coexisting FLT3 genomic alterations and\u002For IDH1\u002F2 mutation. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option.\n\n   For patients with MDS (selected sites and regions):\n   1. Patients with MDS must have bone marrow blasts ≥ 5%\n   2. Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles of treatment with HMA\n\n      For patients with MM (selected sites and regions):\n   3. Have a confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) 2016 classification (Kumar, 2016) and whose disease has progressed after treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb); patients must not be candidates for available therapies with established clinical benefit\n   4. Have measurable disease as defined in the protocol\n   5. Meet the laboratory parameters set in the protocol\n\n      For patients with relapsed\u002Frefractory AML in the venetoclax and azacitidine combination cohort (in countries and sites where permitted):\n   6. Have MLLr or NPM1m.\n\n      For patients with relapsed\u002Frefractory AML in the gilteritinib combination cohort (in countries and sites where permitted):\n   7. Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD\u002FD835 or FLT3-TKD\u002FI836.\n\n      For patients with relapsed\u002Frefractory AML with NPM1 enrolled in the RP2D confirmation cohort:\n   8. Must have ≥5% blasts in bone marrow by morphologic assessment\n   9. Must not have received prior treatment with a menin inhibitor\n\n      For patients with newly diagnosed AML:\n   10. Must have AML as defined by WHO 2022 criteria with a documented MLLr or NPM1m (patients with AML characterized by MLL partial tandem duplications, MLL deletions, or trisomy 11 are not eligible)\n   11. Must not have received treatment for AML with the exception of hydroxyurea for control of white blood cell counts.\n\n   For patients in Phase 2:\n2. Have a confirmed diagnosis of relapsed AML or ALL according to WHO 2022 classification, as determined by pathology review at the treating institution, and who have ≥5% blasts by morphologic assessment in the bone marrow. Patients with extramedullary disease or peripheral blasts as the only manifestation of relapse are not eligible. Patients must have received clinically applicable standard therapies with confirmed survival benefit. Patients must not have had prior exposure to a menin inhibitor.\n3. Have a documented KMT2A (MLL)-fusion assessed at relapse or immediately prior to the determination of refractory status. KMT2A genetic alterations other than fusions (eg, KMT2A-PTD, amplification, point mutation) are not permitted.\n\n   For all patients:\n4. Be \\> 18 years of age. For countries and sites where approved, for DSP-5336 monotherapy, acute leukemia patients ≥12 years of age who weigh ≥40 kg may be enrolled.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. For monotherapy, WBC below 30,000\u002Fμ at enrollment. For the combination arms, WBC count must be below 25,000\u002FuL at enrollment and prior to starting treatment. (Hydroxyurea and steroids for cytoreduction purposes are allowed prior to enrollment and during study treatment)\n7. Clearance of creatinine level ≥ 50 ml\u002Fmin, assessed by the CPK-EPI formula (2021 version and Cystatin C not required)\n8. Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome)\n9. Aspartate aminotransferase (AST) ≤3.0 times ULN\n10. Alanine aminotransferase (ALT) ≤3.0 times ULN\n11. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia or neuropathy\n12. Be willing to attend study visits as required by the protocol\n13. Have an estimated life expectancy ≥3 months, based on the investigator's assessment\n14. Females of childbearing potential must have a negative serum pregnancy test. Females of childbearing potential are defined as women who have (1) experienced menarche and have not undergone sterilization procedures (hysterectomy, or bilateral oophorectomy), or have (2) not experienced menopause as defined in the protocol.\n15. All men and all women of childbearing potential and male patients' partners who are women of childbearing potential are required to use a highly effective method of contraception during the study and for 6 months (for females and males alike) after the last dose of study drug. Further guidelines noted in protocol.\n16. Have AML\u002FALL\u002FMDS\u002FMM bone marrow material suitable for genomic analysis of AML,ALL, MDS, or MM genetic alterations. Note: If a bone marrow material is insufficient, an alternative suitable tissue (ex: peripheral blood) must be provided.\n\nExclusion Criteria:\n\n1. Has a left ventricular ejection fraction (LVEF) \\\u003C50%, as determined by ECHO\n2. Histological diagnosis of acute promyelocytic leukemia\n3. Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336\n4. Have abnormal ECGs at screening that are clinically significant, such as (QTc \\>480 msec, with QTc corrected according to Fridericia's formula (QTcF). For clinical sites in the UK, have abnormal ECGs at screening that are clinically significant, such as QTc ≥470 msec and ≥450 msec with QTc corrected according to Fridericia's formula (QTcF), for females and males, respectively. In addition, patients with a history of prolonged QT syndrome or who are required to take therapies associated with QT-interval prolongation are excluded.\n\n   Note: In case of bundle branch block, QT interval correction can be performed.\n5. Has an active and uncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1.\n6. Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4\u002F5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he\u002Fshe can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (Arm B) with approval of the medical monitor.\n7. Had major surgery within 28 days prior to the first dose of DSP-5336\n8. Has active central nervous system leukemia (prophylactic intrathecal chemotherapy is allowed).\n9. Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. For clinical sites in the UK, underwent CAR-T therapy or other modified T-cell therapy within 6 months prior to the first dose of DSP-5336.\n10. Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD\n11. Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 7 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336\n12. In the opinion of the treating investigator, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results; these conditions include, but are not limited to: clinically significant non-healing or healing wounds; concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV; see Section 21.2); concurrent unstable angina; concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation); recent (within the prior 6 months) myocardial infarction; acute coronary syndrome within the previous 6 months; significant pulmonary disease (shortness of breath at rest or on mild exertion), eg, due to concurrent severe obstructive pulmonary disease, concurrent hypertension not controlled with concomitant medication, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 6 months\n13. Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection.\n\n    For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative.\n14. Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication\n15. Have cognitive, psychological, or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol, or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures\n16. Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolled if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug\n17. Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1 dose escalation).\n\n    For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment.\n18. Have a history of Torsades de Pointes\n19. Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336\n20. Have plasma cell leukemia (\\>2.0 x 109 \u002FL plasma cells in blood by standard differential) (for patients with MM)\n21. For patients intending to enroll into the combination cohort with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed)\n22. Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product\n23. For clinical sites in the UK: In Arm E (DSP-5336 + venetoclax\u002Fazacitidine), have received a live vaccine within 30 days prior to the first dose of DSP-5336","12 Years",{"count":84,"type":21},606,[24,86],"PHASE2","A phase 1\u002F2 dose escalation \u002F dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.",[89,37,40,90],"Leukemia, Myeloid, Acute","Myelodysplastic Syndromes",[92,93,94,95,96,97,98],"Relapsed or refractory AML","MLLr","Menin","NPM1m","KMT2A","MDS","MM","2026-03-20",{"date":101,"type":53},"2026-03-24",{"date":103,"type":53},"2022-02-28",{"date":105,"type":21},"2027-12-31",{"name":107,"class":108},"Sumitomo Pharma America, Inc.","INDUSTRY",104,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":61},"100482674","phase-2-cd34-transplants-for-leukemia-and-lymphoma-100482674","NCT05565105","CD34+ Transplants for Leukemia and Lymphoma","A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma","Inclusion Criteria:\n\n* Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:\n\n  1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).\n  2. Secondary AML in 1st remission\n  3. AML in 1st relapse or 2nd remission\n  4. ALL\u002FCLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL\u002FCLL 2nd remission\n  5. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.\n  6. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:\n\n     1. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.\n     2. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible\u002Fappropriate for autologous transplant.\n  7. Chronic myelomonocyte leukemia: CMML-1 and CMML-2.\n\nThe following inclusion criteria are also required:\n\n* Patient's age includes from ≥18 to ≤74 years old.\n* Patients may be of either gender or any ethnic background.\n* Patients must have a Karnofsky (adult) Performance Status of at least 70%\n* Patients must have adequate organ function measured by:\n\nCardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.\n\nHepatic: \\\u003C 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.\n\nRenal: serum creatinine: s; 1.2 mg\u002FdL or if serum creatinine is outside the normal range, then CrCl \\> 30 ml\u002Fmin (measured or calculated\u002Festimated).\n\nPulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).\n\nEach patient must be willing to participate as a research subject and must sign an informed consent form.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* Active viral, bacterial or fungal infection\n* Patient seropositive for HIV-I \u002FII; HTLV -I \u002FII\n* Presence of leukemia in the CNS","74 Years",{"count":119,"type":21},100,[86],"This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.",[89,37],[124],"Stem Cell Transplant","NOT_YET_RECRUITING","2026-03-02",{"date":128,"type":53},"2026-03-03",{"date":130,"type":21},"2026-06",{"date":132,"type":21},"2033-06",{"name":134,"class":135},"Guenther Koehne","OTHER",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":61},"100582287","phase-2-effectiveness-and-safety-of-inodli-for-relapsed-b-alllbl-after-allo-hsct-100582287","NCT06861348","Effectiveness and Safety of InO±DLI for Relapsed B-ALL\u002FLBL After Allo-HSCT","Effectiveness and Safety of Inotuzumab Ozogamicin±Donor Lymphocyte Infusion for Relapsed B Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma After Allogeneic Hematopoietic Stem Cell Transplantation：Phrase II, Multicenter Study","ZJU-HSCT-INO","Inclusion Criteria:\n\n1. Aged 14-65 years, male or female;\n2. Participants with CD22 positive B-ALL\u002FLBL who relapsed after allo-HSCT from a related or unrelated donor (regardless of CD22 expression);\n3. ECOG physical status score 0\\~3, Karnofsky score ≥70;\n4. No active grade III\u002FIV graft-versus-host disease (GvHD) or any active liver GvHD, no history of venous occlusive disease (VOD); No active GvHD and no previous history of VOD;\n5. Creatinine clearance rate≥50 mL\u002Fmin (estimate by Cockcroft-Gault Equation);\n6. Liver function: alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 3×upper limit of normal (ULN), and total bilirubin ≤ 2×ULN;\n7. Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography;\n8. Estimated life expectancy \\>3 months;\n9. Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.\n\nExclusion Criteria:\n\n1. Allergic or with a history of serious adverse reactions to drugs or drugs with similar chemical structure in this study;\n2. Women who are pregnant or breastfeeding, as well as those who are unwilling to take effective contraceptive measures;\n3. Severe cardiac dysfunction: left ventricular ejection fraction (LVEF) \\\u003C60%; Or severe arrhythmia: a history of a clinically significant corrected interval (QTc) prolongation (male \\>450ms; female\\>470 ms), ventricular tachycardia, atrial fibrillation, second degree atrioventricular block; myocardial infarction and coronary heart disease with clinical symptoms requiring medical treatment within one year before enrollment;\n4. Severe pulmonary disorders (obstructive or restrictive ventilation disorder);\n5. Severe liver function impairment: ALT, AST, or TBIL is more than 3 times higher than the upper limit of normal value (ULN);\n6. Severe renal impairment: serum Cr is more than 2 times higher than the upper limit of normal (ULN); Or 24-hour urinary creatinine clearance \\\u003C50ml\u002Fmin;\n7. Participants with active infection or active bleeding who were deemed intolerance to InO treatment by the investigators;\n8. A history of new thrombosis, embolism, cerebral hemorrhage or other diseases within one year before enrollment;\n9. Participants suffer from known or other mental disorders that investigators are unable to obtain informed consent and may interfere with their ability to comply with research requirements;\n10. A history of major organ surgery within the past six weeks;\n11. Drug abuse or chronic alcohol abuse that may affect the study results;\n12. Participants with a history of organ transplantation other than HSCT (except BMT);\n13. Other situations identified by the investigator as unsuitable to participate in the study.","14 Years","65 Years",{"count":147,"type":21},23,[86],"B cell acute lymphoblastic leukemia (B-ALL)\u002FLymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of B-lineage precursor cells. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potential curable therapy for ALL, especially for high-risk ALL patients. However, post-HSCT recurrence is the primary cause of transplant failure and salvage treatment option for this patient population are very limited. Current data showed that the CR rate and overall survival (OS) in adults with ALL who relapse after transplantation are as low as 30% and 25%, respectively, and the prognosis is extremely dismal. Some researchers have successfully salvage treated relapsed B-ALL patients after transplantation with donor lymphocyte infusions (DLI), but the response rate of DLI alone is usually less than 10%, with increased risk of Graft-Versus-Host Disease (GvHD). In the immunotherapy era, the introduction of immuno-designed therapies like bispecific antibody constructs, antibody conjugates, as well as chimeric antigen receptor T cell (CAR-T) therapy, have immensely broadened the treatment landscape of relapsed or refractory (r\u002Fr) B-ALL. Inotuzumab ozogamicin (InO) is a CD22-targeted monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin. Based on the pivotal Phase III INO-VATE clinical trial published in N Engl J Med in 2016, compared to standard chemotherapy, 73% (64\u002F88) of r\u002Fr B-ALL patients treated with InO achieved CR\u002FCRi in the first cycle. Superior CR duration, OS and relapse free survival (RFS) was also observed in the InO group. Subgroup analysis showed that the treatment benefits were consistent for patients who relapsed after allo-HSCT. Moreover, a single-center retrospective study attempted to salvage treat relapsed B-ALL patients after transplantation with combined InO and DLI, results showed that six out of eight patients achieved CR after the first InO course and 75% of patients obtained MRD negativity after the second course, which is quite satisfactory. Therefore, we designed a Phase II clinical study of InO combined with or without DLI in patients with recurrent acute B-ALL\u002FLBL after allo-HSCT, with expectation to increase CR rate and improve long-term survival.",[37],[152,153,154,155],"Inotuzumab Ozogamicin","Donor Lymphocyte Infusion","Relapsed B cell Acute Lymphoblastic Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation","2025-03-03",{"date":158,"type":53},"2025-03-06",{"date":160,"type":21},"2025-03-01",{"date":162,"type":21},"2027-04-30",{"name":164,"class":135},"First Affiliated Hospital of Zhejiang University"]