[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myelomonocytic-leukemia-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myelomonocytic-leukemia-2":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,96],{"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":39,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100421728","phase-1-study-of-oral-administration-of-lp-118-in-patients-with-relapsed-or-refractory-cll-sll-mds-mdsmpn-aml-cmml-2-mpn-bp-all-mf-nhl-rt-mm-or-t-pll-100421728",false,"NCT04771572","Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS\u002FMPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.","A Phase 1\u002F1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years of age at the time of Screening with the following exception as outlined below:\n\n   -For T cell and B cell ALL subjects with age between 13 - 18 years, their body weight shall be ≥ 40 kg.\n2. Eligible subject must have an advanced hematologic malignancy including:\n\n   Group 1:\n\n   Group 1a\n   * Relapsed or refractory low risk tumor lysis CLL\u002FSLL subjects (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.\n   * For CLL\u002FSLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days as these subjects, progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n\n   Group 1b\n   * Morphologically confirmed diagnosis of MF in accordance with the WHO 2016 revised criteria, that is relapsed, intolerant, and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Morphologically confirmed diagnosis of MDS\u002FMPN, excluding juvenile myelomonocytic leukemia (JMML), in accordance with WHO 2016 revised criteria, that is relapsed and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Chronic myelomonocytic leukemia (CMML) with \\\u003C9% blasts;\n   * Or atypical chronic myeloid leukemia (aCML) with Hgb \\> 10g\u002FdL, WBC count \\\u003C 50 x 109 cells\u002FL, \\\u003C10% immature circulating cells;\n   * Or MDS\u002FMPN with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T) with Hgb \\> 10g\u002FdL;\n   * Or myelodysplastic\u002Fmyeloproliferative neoplasm, unclassifiable (MDS\u002FMPN-UC)\n   * CMML-2 with 10-19% blasts as defined by WHO 2016 revised criteria that is relapsed and\u002For refractory to prior HMA therapy;\n   * Relapsed and\u002For refractory MPN-BP as defined by WHO 2016 revised criteria that is transformed MPN with \\>20% myeloid blasts in the peripheral blood or bone marrow, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * MDS subjects with refractory anemia with excess blasts (MDS-EB; subtype MDS-EB-1 or MDS-EB-2) as defined by WHO 2016 revised criteria and\u002For MDS with high- or very high-risk (risk score \\> 4.5) per the Revised International Prognostic Scoring System (IPSS-R, refer to Appendix 11; Section 15.13) who have no available therapies known to provide clinical benefit;\n   * Relapsed or refractory AML subjects (including de novo AML, secondary AML evolving from MDS or MPN or other antecedent hematologic disorder, and therapy-related AML) as defined by WHO 2016 revised criteria, subjects who have no available therapies known to provide clinical benefits; subjects with prior BCL-2 inhibitor therapy are permitted. WBC needs to be ≤ 25 × 109 cells\u002FL at the time of initiating investigational therapy (hydroxyurea is allowed to control WBC prior to and during therapy).\n\n   Group 1c\n   * Relapsed or refractory low risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Low risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Low risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 and have no treatment options available known to provide clinical benefit;\n   * Low risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n\n   Group 1d\n   * Relapsed or refractory ALL with dexamethasone run-in \\[5 days, dexamethasone 10mg\u002Fm2 (divided BID)\\];\n   * Or r\u002Fr ALL in remission but with detectable MRD (MRD +) by any detection method per institution standard of practice;\n   * IT chemo (per institutional SOC) is permitted prior to LP-118 C1D1 dosing, and then concomitantly on treatment if in best interest of the subject;\n   * Relapsed or refractory ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and failed.\n   * Relapsed or refractory ALL subjects with age between 13 - 18 years and have body weight ≥ 40kg, ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and progressed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and progressed.\n\n   Group 2\n   * Relapsed or refractory intermediate and high risk tumor lysis CLL\u002FSLL subjects who have received at least two prior therapies;\n   * Relapsed or refractory intermediate and high risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Intermediate and high risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Intermediate and high risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Intermediate and high risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n3. For Group 1d ALL subjects only, white blood cell (WBC) count ≤ 25 × 109 cells\u002FL at the time of enrollment (glucocorticoids or hydroxyurea is permitted to control WBC count prior to and during therapy).\n4. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.\n5. Adequate cardiac function defined as shortening fraction of ≥ 40% by 2D echocardiogram without Doppler.\n6. Subject must have adequate bone marrow (independent of growth factor support), coagulation, renal, and hepatic function, per laboratory reference ranges at Screening as follows:\n\n   Bone marrow criteria:\n   * Group 1 (r\u002Fr low risk tumor lysis CLL\u002FSLL (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm), NHL, RT, MM, T-PLL):\n   * Absolute Neutrophil Count (ANC) ≥ 1 x 109\u002FL (An exception is for subjects with an ANC\\\u003C1 x 109\u002FL and bone marrow heavily infiltrated with underlying disease)\n   * Platelets ≥ 50 x 109\u002FL on day of screening (entry platelet count must be independent of transfusion with 14 days of screening);\n   * Hemostasis criteria: Activated partial thromboplastin time (APPT) and prothrombin time (PT) ≤ 1.5 × the upper limit of normal (ULN);\n   * Renal function criteria: Serum creatinine ≤ ULN (per local institution reference range) or Calculated creatinine clearance (Cr Cl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR by Cockcroft-Gault formula using actual body weight.\n   * Hepatic function criteria: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n7. Females of childbearing potential (i.e., non-postmenopausal for at least 2 years or surgically sterile) and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 90 days after discontinuing study drug:\n\n   * Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable;\n   * Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy;\n   * Intrauterine device;\n   * Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) associated with inhibition of ovulation initiated for at least 1 month prior to study drug administration.\n8. Females of childbearing potential must have a negative pregnancy result as follows:\n\n   * At Screening on a serum sample obtained within 7 days prior to the first study drug administration, and\n   * Prior to dosing on a urine or serum sample obtained on the first day of study drug administration if ithas been \\> 7 days since obtaining the serum pregnancy test results in Screening.\n   * If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation\n9. Male subjects must refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug.\n10. Subject must be able to understand and voluntarily sign and date an informed consent form (ICF), approved by an IRB, prior to any protocol-related procedures.\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n1. Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-118, or subjects on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n2. Subject has a history of other malignancies within past 12 months that are active and could result in competing risks. These cases shall be discussed with the Medical Monitor with the exception below.\n\n   * Subject with breast cancer or prostate cancer on endocrine therapy with stable disease;\n   * Continuation of maintenance therapy in patients with adequately treated malignancy\n   * Adequately treated in situ carcinoma of the cervix uteri;\n   * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n   * Cancer with expected survival of 2 years or more or that will not confound evaluation of LP-118 treatment\n3. Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of LP-118, or has not recovered to ≤ Grade 2 clinically significant AEs of the previous therapy (excluding neuropathy):\n\n   * Any anti-neoplastic therapy including chemotherapy, hormonal therapy, radiotherapy, biologic or immunotherapy, targeted small molecule agents, etc. (corticosteroid therapy \\\u003C 20 mg\u002Fday prednisone equivalent according to institutional guidelines to treat disease associated symptoms are permitted);\n   * For MF subjects who come off JAK2 antagonists, allow washout for 2 days as these subject's progress quickly after treatment discontinuation and remain eligible (steroids may be given during these two days to allow disease control).\n   * Subjects in need of immediate cytoreduction should be excluded.\n   * Any investigational therapy.\n   * Live vaccines\n4. Subject has received the following medications, therapies, or natural products within 7 days prior to the first dose of LP-118:\n\n   * Cytochrome P450, family 3, subfamily A (CYP3A) strong inhibitors (itraconazole, etc.), or substrates (Appendix 19);\n   * Subject has received strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers within 14 days prior to the first dose of LP-118 (Appendix 19);\n   * Grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit;\n   * There is a 28-day washout period required for subjects who have had prior CAR-T treatment if there is no evidence of cytokine release syndrome (CRS) or other adverse events related to the CAR-T treatment, per discussion with the Medical Monitor.\n5. Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect his\u002Fher participation in this study. Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the study, place the subject at unacceptable risk or interfere with the interpretation of the results. For subjects who have required surgical intervention for any above diseases within the past 6 months, a discussion with the Investigator and the Medical Monitor is needed.\n6. Subject has baseline prolongation of the heart rate-corrected QT (QTcF) interval ≥ 480 ms (calculated per Fridericia's formula \\[QTcF = QT\u002FRR (1\u002F3)\\])), a cardiovascular disability status of New York Heart Association Class ≥ 2 or associated other significant screening ECG or ultrasonic cardiogram abnormalities, per Investigator's judgement. For any subject with underlying RBBB or LBBB, cardiology review is needed to correct QTcF calculation using Sponsor recommended formula.\n7. Subject has significant a history of congenital long QT syndrome or Torsades de Pointes (TdP), uncontrolled or symptomatic arrhythmias, congestive heart failure, myocardial infarction, stroke, or intracranial hemorrhage within 6 months prior to the first dose of LP-118.\n8. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   * Uncontrolled active systemic infection (bacterial, fungal, viral);\n   * Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HbsAg positive, or HbcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive);\n   * Unexplained fever \\> 38.5°C within 7 days prior to the first dose of study drug administration (at the discretion of the Investigator if the fever is considered attributed to the subject's malignancy or an explained infection may be enrolled).\n9. A female subject is pregnant or breast-feeding.\n10. Subject incapacity to swallow oral medications, with any malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that, in the opinion of the Investigator, may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally.\n11. Subjects with known and active central nervous system (CNS) involvement at Screening.\n12. Subjects with known hypersensitivity to any of the components of LP-118 (see Investigators Brochure for a list of components).\n13. Subjects who are taking QT-prolonging drugs that are known to cause Torsades de Pointes (TdP) (See Appendix 17 for the list of medications that are associated with TdP). In the event a prohibited medication might cause TdP, the PI must first determine if the risk to benefit is in favor of the subject and then discuss with the Medical Monitor about that particular medication on a case-by-case basis.\n14. Major surgery within 14 days prior to the first dose of study drug.","ALL","13 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Non Hodgkin Lymphoma","Richter Transformation","Multiple Myeloma","T-cell-prolymphocytic Leukemia","Acute Myeloid Leukemia","Acute Lymphocytic Leukemia","Myeodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myelofibrosis","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Chronic Myelomonocytic Leukemia-2","Myelodysplastic Neoplasm in Blast Phase",[40,41,42],"Hematological Malignancies","Relapsed","Refractory","RECRUITING","2026-04-29",{"date":46,"type":47},"2026-05-05","ACTUAL",{"date":49,"type":47},"2022-05-08",{"date":51,"type":20},"2027-12-31",{"name":53,"class":54},"Newave Pharmaceutical Inc","INDUSTRY",8,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":79,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100589101","phase-1-a-phase-1-study-of-stx-0712-in-patients-with-advanced-hematological-malignancies-cmml-and-aml-100589101","NCT06950034","A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)","A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies","Inclusion Criteria:\n\n* Refractory\u002Fresistant CMML, defined as: Diagnosis of CMML 1 or 2; and has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease OR\n* Relapsed\u002Frefractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and\u002For monocytic precursors (promonocytes\u002Fmonoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \\\u003C30,000\u002FµL (microliters) and \\\u003C20% circulating blasts.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n* Life expectancy of \\>2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator.\n* Adequate organ function.\n* Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion.\n* Able to understand and willing to sign a written informed consent form.\n* Willing and able to comply with study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap syndromes other than CMML. For AML: Acute Promyelocytic Leukemia (APL) or Isolated extramedullary disease.\n* Eligible for an immediate allogenic stem cell transplant (alloSCT).\n* Current active use of nicotine products including tobacco, nicotine patches or vaping products.\n* Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.\n* Has active autoimmune condition requiring immunosuppressive treatment or is receiving immunosuppressive therapy for the treatment of autoimmune disorders, allergies, or other clinical symptoms. Systemic steroids \\\u003C10 mg (milligrams) daily of prednisone equivalent are allowed; and intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids are allowed.\n* Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and AML participants, hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712. Hydroxyurea will also be permitted for first cycle of STX-0712 treatment for participants with proliferative CMML or AML with high white blood count (WBC ≥25,000\u002FµL).\n* Received an investigational treatment within 30 days prior to dosing with STX-0712.\n* Received Granulocyte Colony Stimulating Factor \\[G-CSF\\], Granulocyte Macrophage Colony Stimulating Factor \\[GM-CSF\\], erythropoietin, romiplostim, or other growth factors within 2 weeks prior to first dose of STX- 0712.\n* Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712.\n* Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled or unstable chest pain, history of heart attack(s), or stroke within 6 months prior to consent, uncontrolled high blood pressure, or clinically significant arrhythmias not controlled by medication).\n* QT interval corrected by Fridericia's formula (QTcF) \\>470 msec for both men and women on Screening electrocardiogram(s) (ECG). Patients with a bundle branch block must have QT interval corrected for bundle branch block.\n* Other than AML or CMML, active malignancy and\u002For cancer history that requires active therapy. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.\n* Active, uncontrolled bacterial, fungal, or viral infection.\n* Known human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Evidence of any other severe or uncontrolled systemic diseases, any other serious and\u002For unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.","18 Years",{"count":65,"type":20},105,[23],"This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.",[69,70,71,37,72,73,30,74,75,76,77,78],"Chronic Myelomonocytic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Chronic Myelomonocytic Leukemia-1","Refractory Chronic Myelomonocytic Leukemia","CMML","Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemias","Refractory Acute Myeloid Leukemia (AML)","Acute Monocytic Leukemia",[80,73,81,82,83,84,69,30,72,85],"refractory\u002Fresistant CMML","AML","monocytic AML","Relapsed\u002Frefractory AML","monocytic-predominant AML","Refractory Acute Myeloid Leukemia","2026-02-05",{"date":88,"type":47},"2026-02-09",{"date":90,"type":47},"2025-03-13",{"date":92,"type":20},"2027-06-30",{"name":94,"class":54},"Solu Therapeutics, Inc",7,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100484186","phase-1-unrelated-umbilical-cord-blood-stem-cell-combined-with-azacitidine-based-treatment-for-advanced-mdscmml-2-and-saml-100484186","NCT05584761","Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML","A Perspective, Multicenter, Open-label and Observational Trial for Unrelated Umbilical Cord Blood Stem Cell Microtransplantation Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and Secondary AML.","1. MDS patients diagnosed due to bone marrow morphology and immunophenotyping (met the World Health Organization(WHO) 2016 diagnosis criterion) and met revised the International Prognostic Scoring System(IPSS) prognostic risk categories intermediate(\\>3-≤4.5), high(\\>4.5-≤6), and very high risk(\\>6), or CMML-2(PB 5-19% or bone marrow 10-19% blast equivalent, and\u002For when any Auer rods are present) patients diagnosed due to bone marrow morphology and immunophenotyping (met the WHO 2016 diagnosis criterion) with white blood cell count(WBC)\\\u003C13x109\u002FL, or AML patients diagnosed due to bone marrow morphology and immunophenotyping (met the WHO 2016 diagnosis criterion) with history of myeloid neoplasms ;\n2. Ineligible for allogeneic hematopoietic stem cell transplantation (HSCT) based on local medical standards and clinical decision guidelines in the study;\n3. Indications for azacytidine (AZA) treatment were determined according to local medical standards and diagnostic decision guidelines in the study;\n4. Morphology and immunophenotyping excluded BCR\u002FABL positive chronic myelogenous leukemia and other myeloid neoplasms including essential thrombocythemia, polycythemia vera and primary myelofibrosis;\n5. Aged 18-80 years old;\n6. Alanine transaminase(ALT), Aspartate Transaminase(AST) and serum bilirubin \\\u003C=2 upper limit of normal (ULN), serum creatinine \\\u003C=150umol\u002FL, myocardial enzyme \\\u003C2xULN (of the same age);\n7. Left ventricularinjection fraction(LVEF)\\>=50% by echocardiogram;\n8. Estimated glomerular filtration rate (eGFR) ≥30mL\u002Fmin\u002F1.73m2 ;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 10. must sign (or their legally-acceptable representative must sign) an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. BCR\u002FABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera and essential thrombocythemia;\n2. Low risk myelodysplastic syndromes according to IPSS or revised IPSS prognostic risk categories;\n3. Acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia;\n4. Allergic to any of the mentioned agent in the study protocol;\n5. Pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods;\n6. With obvious dysfunction of liver or kidney, not fulfilling the inclusion criteria;\n7. With organic heart disease, which causes clinical symptoms or cardiac dysfunction ( ≥ Class 2 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA );\n8. At the same time suffering from other malignant tumors, with the exception of the following: (1) malignancy treated with curative intent and with no evidence of active disease present for more than 5 years prior to screening; (2) adequately treated lentigo maligna melanoma without current evidence of disease or adequately-controlled non-melanomatous skin cancer (even if less than 3 years prior to screening); (3) adequately treated cervical carcinoma in situ without current evidence of disease (even if less than 3 years prior to screening);\n9. Known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C;\n10. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or history of myocardial infarction within 6 months prior to first dose with study drug, or any Class 3 or 4 cardiac disease as defined by NYHA;\n11. Any concurrent medical condition or disease (eg, active systemic infection) that may interfere with the research procedure or outcome, or that the subject may have a risk to participate in the study;\n12. Cannot understand or follow the study protocol;\n13. Patients under 12 years old or over 80 years old;\n14. Received major surgery within 4 weeks prior to randomization;\n15. Participated in other clinical researches at the same time one month before enrollment;\n16. Cannot matching suitable cord blood stem cell;\n17. Addicted to illegal drugs;\n18. Have mental disorders or cognitive disorders.","80 Years",{"count":105,"type":20},50,[23,107],"PHASE2","This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.",[110,37,111],"Myelodysplastic Syndromes","Secondary Acute Myeloid Leukemia",[113,114,115,116,117],"umbilical cord blood stem cell","microtransplantation","myelodysplastic syndromes","Chronic myelomonocytic leukemia","secondary acute myeloid leukemia","2022-10-16",{"date":120,"type":47},"2022-10-18",{"date":122,"type":47},"2022-03-01",{"date":124,"type":20},"2026-12-31",{"name":126,"class":127},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1]