[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-acute-lymphoblastic-leukemia-with-t922q341q112-bcr-abl1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-acute-lymphoblastic-leukemia-with-t922q341q112-bcr-abl1":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,70,116],{"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":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100161234","phase-1-inotuzumab-ozogamicin-and-combination-chemotherapy-in-treating-patients-with-acute-lymphoblastic-leukemia-100161234",false,"NCT01371630","Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia","Phase I\u002FII Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and\u002For 1 dose of anthracycline or alkylating agents) are allowed.\n2. Patients unfit ≥ 18 - \\\u003C 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.\n\n   These patients are defined as having at least one of the below comorbidities:\n   1. ECOG performance status ≥ 2\n   2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)\n   3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)\n   4. Creatinine clearance \\\u003C 45 mL\u002Fmin, and\n   5. Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal\n\n   \u003C!-- -->\n\n   1. If they achieved CR, they are assessable only for event-free and overall survival, or\n   2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.\n4. Zubrod performance status 0-3.\n5. Adequate liver function (bilirubin \\\u003C 1.95 mg\u002FdL and SGPT or SGOT \\\u003C 3 x upper limit of normal \\[ULN\\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \\\u003C 2.6 mg\u002FdL and creatinine \\\u003C 3 mg\u002FdL.\n6. Provision of written informed consent.\n7. Patients in first remission are eligible.\n8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.\n\nExclusion Criteria:\n\n1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.\n2. Patient with active heart disease (NYHA class \\> 3 as assessed by history and physical examination).\n3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \\\u003C 40% are excluded.\n4. Patients with active hepatitis are excluded.\n5. Pregnant or breast-feeding women are excluded.","ALL","18 Years",{"count":19,"type":20},276,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy 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. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.",[27,28,29,30,31,32,33,34,35],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Burkitt-Like Lymphoma With 11q Aberration","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent B Acute Lymphoblastic Leukemia","Recurrent Burkitt Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory Burkitt Lymphoma","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":40},"2011-08-26",{"date":44,"type":20},"2027-12-25",{"name":46,"class":47},"M.D. Anderson Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":48},"100596094","phase-1-asciminib-as-maintenance-treatment-after-cellular-therapies-for-adults-with-philadelphia-chromosome-positive-acute-lymphoblastic-leukemia-100596094","NCT07040982","Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","Pilot Study of Asciminib as a Maintenance Treatment Post Cellular Therapies in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* PRE-SCREENING: Documented informed consent of the participant and\u002For legally authorized representative\n* PRE-SCREENING: Age ≥ 18 years\n* PRE-SCREENING: Participant was diagnosed with Ph+ ALL according to World Health Organization criteria. The BCR::ABL1 translocation may be detected by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next generation sequencing (NGS), or cytogenetics at least once any time prior to cellular therapy. Participants may have p190 or p220 isoform, and participants with T315I mutation are not excluded\n* PRE-SCREENING: Participant meets one of the following criteria:\n\n  * Arm 1: Have a date for HSCT scheduled within the next 30 days or have received HSCT within the last 30 days. Note: all HSCT donors, conditioning regimens, and GVHD prophylaxis regimens will be acceptable.\n  * Arm 2: Have a date for CAR T cell infusion scheduled within the next 30 days or have received CAR T cell infusion within the last 30 days\n* PRE-SCREENING: History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant is between day +30 and +150 after one of the following cellular therapies:\n\n  * Arm 1: HSCT\n\n    * Participants on Arm 1 must be fully engrafted post-HSCT.\n  * Arm 2: CD19-targeted CAR T cell therapy (brexucabtagene autoleucel, tisagenlecleucel, obecabtagene autoleucel, investigational CD19 CAR T cell therapy)\n\n    * Participants on Arm 2 must be fully recovered from cytopenia\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Day 30 (+\u002F- 5 days) marrow post cellular therapy should show evidence of complete morphologic remission defined as \\\u003C 5% bone marrow (BM) blasts, no extramedullary disease, and transfusion independence\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant should have no morphological evidence of relapse\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 for 3 days\n\n  * NOTE: Patients are allowed growth factors\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Platelets ≥ 75,000\u002Fmm\\^3\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Hemoglobin ≥ 9g\u002FdL\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: serum creatinine \\\u003C1.5 mg\u002FdL\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Bazett's corrected QT interval (QTcB) ≤ 480 ms\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Oxygen (O2) saturation \\> 90% on room air\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior treatment failure with asciminib\n* Treatment with strong inducers of CYP3A is not allowed and should be switched to an alternative at least 1 week prior to the start of study treatment\n* ARM 1: Treatment with prior HSCT is allowed\n* ARM 2: Treatment with prior CAR T cell therapy is allowed\n* Cardiac or cardiac repolarization abnormality, including any of the following:\n\n  * History within 6 months prior to starting study treatment of myocardial infarction (MI), or coronary artery bypass graft (CABG)\n  * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)\n  * Fridericia's corrected QT interval (QTcF) at screening ≥ 450 msec (male patients), ≥ 470 msec (female patients)\n  * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome\n* History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* ARM 1: Active grade 3 or higher graft-versus-host disease (GVHD) after allogeneic HSCT within 14 days of enrollment. Note: prednisone administration (flat dose of 0.5 mg\u002Fkg) is allowed. Patients receiving any other medication to control active\u002Fprogressive GVHD will be excluded\n* Clinically significant uncontrolled illness\n* Active infection not responding to treatment\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":57,"type":20},30,[23],"This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.",[27],"2026-06-16",{"date":63,"type":40},"2026-06-18",{"date":65,"type":20},"2026-12-19",{"date":67,"type":20},"2028-06-13",{"name":69,"class":47},"City of Hope Medical Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":48},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","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","15 Years","80 Years",{"count":79,"type":20},100,[24],"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.",[83,84,85,86,87,88,27,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"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","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","2026-05-20",{"date":110,"type":40},"2026-05-22",{"date":112,"type":40},"2016-05-19",{"date":114,"type":20},"2027-05-31",{"name":46,"class":47},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":48},"100610170","phase-2-dose-adjusted-epoch-with-or-without-rituximab-plus-ponatinib-for-the-treatment-of-newly-diagnosed-philadelphia-chromosome-positive-acute-lymphoblastic-leukemialymphoma-100610170","NCT07224100","Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Phase II Study of Dose-Adjusted EPOCH ± Rituximab + Ponatinib for Adults With Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph+ B-ALL. Ph status will be determined by routine cytogenetics, fluorescence in situ hybridization (FISH), and\u002For reverse transcriptase-polymerase chain reaction (RT-PCR) for the BCR::ABL1 translocation\n* Marrow or blood involvement by abnormal lymphoblasts detectable by multiparameter flow cytometry (MFC)\n* Total bilirubin (TBili) ≤ 1.5 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point TBili must be ≤ 4 x ULN)\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the TBili is ≤ 5 x ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional ULN\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the ALT\u002FAST are ≤ 8 x ULN)\n* Calculated creatinine clearance of \\> 30 ml\u002Fmin\u002F1.73m\\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible\n* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL)\n* Ability to give informed consent and comply with the protocol\n* Anticipated survival of at least 3 months, independent of ALL\n* Female subjects of reproductive potential must agree to use an effective method of birth control from the time of signing the consent form until one of the following:\n\n  * For subjects not expected to receive rituximab (i.e., CD20-negative): at least 3 weeks after the last dose of ponatinib, or\n  * For subjects expected to receive rituximab (i.e., CD20-positive): at least 12 months after the last dose of rituximab\n  * A subject does not have reproductive potential if they are (1) surgically sterilized, or (2) postmenopausal (i.e., a female who is \\> 50 years old or who has not had menses for ≥ 1 year), or (3) not heterosexually active\n* Male subjects must agree to use an effective method of birth control and to not donate sperm from the time of signing the consent form until at least 3 weeks after the last dose of ponatinib\n\nExclusion Criteria:\n\n* Burkitt lymphoma\u002Fleukemia\n* No prior systemic therapy for ALL except to control acute symptoms and\u002For hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)\n* No isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* History of acute pancreatitis within 1 year of enrollment or known chronic pancreatitis\n* Symptomatic atherosclerotic cardiovascular disease (e.g., myocardial infarction, cerebrovascular accident, peripheral arterial disease, etc.) within 1 year of enrollment\n* Active resistant hypertension, defined as having an ambulatory blood pressure above goal despite use of 3 antihypertensive medications from different classes\n* Venous thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of enrollment\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* May not be pregnant or nursing. Pregnancy test is only required in females, unless they do not have reproductive potential. For subjects not expected to receive rituximab (i.e., CD20-negative), nursing can occur 1 week after the last dose of ponatinib. For subjects expected to receive rituximab (i.e., CD20-positive), nursing can occur 6 months after the last dose of rituximab",{"count":124,"type":20},33,[24],"This phase II trial tests the effect of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib in treating patients newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is a drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. DA-EPOCH involves a longer exposure time to doxorubicin, vincristine and etoposide compared to a higher concentration over a shorter time which may provide better tumor response. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Ponatinib blocks BCR::ABL1 and other proteins, which may help keep cancer cells from growing and may kill them. It may also prevent the growth of new blood vessels that tumors need to grow. Ponatinib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving DA-EPOCH with or without rituximab plus ponatinib may be safe, tolerable, and\u002For effective in treating patients with newly diagnosed Ph+ ALL.",[27,128,129],"B Lymphoblastic Leukemia\u002FLymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1","Lymphoblastic Lymphoma","2026-04-14",{"date":132,"type":40},"2026-04-16",{"date":134,"type":40},"2026-03-30",{"date":136,"type":20},"2028-07-31",{"name":138,"class":47},"University of Washington"]