[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"accelerated-phase-chronic-myelogenous-leukemia-bcr-abl1-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:accelerated-phase-chronic-myelogenous-leukemia-bcr-abl1-positive":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904",false,"NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","ALL","15 Years","80 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Myelomonocytic Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","RECRUITING","2026-05-20",{"date":55,"type":56},"2026-05-22","ACTUAL",{"date":58,"type":56},"2016-05-19",{"date":60,"type":20},"2027-05-31",{"name":62,"class":63},"M.D. Anderson Cancer Center","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":64},"100306003","phase-2-blinatumomab-methotrexate-cytarabine-and-ponatinib-in-treating-patients-with-philadelphia-chromosome-positive-or-bcr-abl-positive-or-relapsedrefractory-acute-lymphoblastic-leukemia-100306003","NCT03263572","Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed\u002FRefractory, Acute Lymphoblastic Leukemia","Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and\u002For BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Diagnosis of one of the following:\n\n   1. Participants ≥ 18 years of age with previously untreated Ph-positive ALL \\[either t(9;22) and\u002For BCR-ABL positive\\] (includes patients initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. These participants could have received one or two courses of chemotherapy with or without other TKIs and still eligible. (Participants with lymphoid accelerated or blast phase CML will be evaluated separately) i. If they achieved CR, they are assessable only for event-free and overall survival, or ii. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n   2. Participants ≥ 18 years of age with relapsed\u002Frefractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n   3. Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n2. Performance status ≤ 2 (ECOG Scale)\n3. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n   1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n   2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR\n   3. Aspartate aminotransferase (AST) ≤ 3 x ULN\n4. Adequate pancreatic function as defined by the following criteria:\n\n   a) Serum lipase and amylase ≤ 1.5 x ULN\n5. For females of childbearing potential, a negative urine pregnancy test must be documented\n6. Female participants who:\n\n   * Are postmenopausal for at least 1 year before the screening visit, OR\n   * Are surgically sterile, OR\n   * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse\n7. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n   * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n   * Agree to completely abstain from heterosexual intercourse\n8. Adequate cardiac function as assessed clinically by history and physical examination.\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Active serious infection not controlled by oral or intravenous antibiotics.\n2. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis\n3. History of alcohol abuse\n4. Uncontrolled hypertriglyceridemia (triglycerides \\> 650mg\u002FL)\n5. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n6. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n7. Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n   * Myocardial infarction (MI), stroke, or revascularization within 3 months\n   * Unstable angina or transient ischemic attack\n   * Congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment\n   * Diagnosed or suspected congenital long QT syndrome\n   * Clinically significant atrial or ventricular arrhythmias (such as artrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n   * Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n   * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility.\n   * Uncontrolled hypertension (diastolic blood pressure \\>90mmHg; systolic \\>140mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control\n8. History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade 3 or above) CNS events including ICANS from prior CART or other T cell engager therapies. Participants with active CNS leukemia - will NOT be excluded\n9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement\n10. Treatment with any investigational antileukemic agents or chemotherapy agents within 2 weeks prior to study entry, unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator.\n11. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n12. History of significant bleeding disorder unrelated to cancer, including:\n\n    * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n    * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)\n13. Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.\n14. Known active infection with HIV, HBV, HCV.","18 Years",{"count":74,"type":20},90,[23],"This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.",[26,28,78,79,80,81,48,82],"BCR-ABL1 Fusion Protein Expression","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Philadelphia Chromosome Positive","Recurrent Acute Lymphoblastic Leukemia","t(9;22)","2026-05-18",{"date":53,"type":56},{"date":86,"type":56},"2017-11-29",{"date":88,"type":20},"2027-11-30",{"name":62,"class":63}]