[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-acute-lymphoblastic-leukemia-philadelphia-chromosome-negative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-acute-lymphoblastic-leukemia-philadelphia-chromosome-negative":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,66,94,104,130,155],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054208","phase-2-inotuzumab-ozogamicin-and-blinatumomab-with-or-without-ponatinib-in-treating-patients-with-newly-diagnosed-recurrent-or-refractory-cd22-positive-b-lineage-acute-lymphoblastic-leukemia-100054208",false,"NCT03739814","Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia","A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease","Inclusion Criteria:\n\n* STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.\n\n  * Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:\n\n    * Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.\n* STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma\u002Fleukemia are not eligible.\n* STEP 1: CD22-positive disease defined as CD22 expression by \\>= 20% of lymphoblasts by local hematopathology evaluation.\n* STEP 1: Philadelphia chromosome\u002FBCR-ABL1-negative or Philadelphia chromosome\u002FBCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and\u002For polymerase chain reaction (PCR).\n* STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and\u002For known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.\n\n  * Categories of CNS Involvement for CNS Evaluation Prior to Registration:\n\n    * CNS 1: CSF has \\\u003C 5 WBC\u002FuL with cytospin negative for blasts; or \\>= 10 red blood cell (RBC)\u002FuL with cytospin negative for blasts.\n    * CNS 2: CSF has \\\u003C 5 WBC\u002FuL with cytospin positive for blasts; or \\>= 10 RBC\u002FuL with cytospin positive for blasts; or \\>= 10 RBC\u002FuL, WBC\u002FuL \\>= 5 but less than Steinherz\u002FBleyer algorithm with cytospin positive for blasts (see below).\n    * CNS 3: CSF has \\>= 5 WBC\u002FuL with cytospin positive for blasts; or \\>= 10 RBC\u002FuL, \\>= 5 WBC\u002FuL and positive by Steinherz\u002FBleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome). Steinherz\u002FBleyer Method of Evaluating Initial Traumatic Lumbar Punctures:\n\n      * If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains \\>= 5 WBC\u002FuL with blasts, the following algorithm should be used to define CNS disease: CSF WBC\u002FCSF RBC \\> 2 x (Blood WBC\u002FBlood RBC count)\n* STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal\u002Ftesticular radiotherapy.\n\n  * Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.\n* STEP 1: Not pregnant and not nursing.\n\n  * This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 7 days prior to registration is required.\n* STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n* STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.\n* STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) \\\u003C 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).\n* STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.\n* STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:\n\n  * On HBV-suppressive therapy.\n  * No evidence of active virus.\n  * No evidence of HBV-related liver damage.\n* STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:\n\n  * Successfully completed complete-eradication therapy with undetectable viral load.\n  * No evidence of HCV-related liver damage.\n* STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.\n* STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for \\>= 2 years.\n* STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.\n* STEP 1: No history of chronic liver disease, including cirrhosis.\n* STEP 1: No history of sinusoidal occlusion syndrome\u002Fveno-occlusive disease of the liver.\n* STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.\n* STEP 1: Total bilirubin, serum =\\\u003C 1.5 x upper limit of normal (ULN)\\*\n\n  * Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =\\\u003C 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =\\\u003C 2 x ULN.\n* STEP 1: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* STEP 1: Creatinine, serum =\\\u003C 1.5 ULN OR creatinine clearance \\>= 40 mL\u002Fmin\n* STEP 1: QT interval by Fridericia's correction formula (QTcF) =\\\u003C 470 msec\n* COHORT 1: Age \\>= 60 years.\n* COHORT 1: Diagnosis of Philadelphia chromosome\u002FBCR-ABL1-negative B-cell ALL.\n* COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and\u002For leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed \\>= 24 hours prior to the initiation of protocol therapy.\n* COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).\n* COHORT 2: Age \\>= 18 years.\n* COHORT 2: Diagnosis of Philadelphia chromosome\u002FBCR-ABL1-negative B-cell ALL.\n* COHORT 2: Relapsed or refractory disease in salvage 1 or 2.\n* COHORT 2: No isolated extramedullary relapse.\n* COHORT 2: Prior allogeneic HCT permitted.\n* COHORT 2: Patients with prior allogeneic HCT must have completed transplantation \\>= 4 months prior to registration.\n* COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy \\>= 30 days prior to registration.\n* COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.\n* COHORT 2: Prior treatment with rituximab must be completed \\>= 7 days prior to registration.\n* COHORT 2: Prior treatment with other monoclonal antibodies must be completed \\>= 6 weeks prior to registration.\n* COHORT 2: Prior treatment for ALL must be completed \\>= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and\u002For leukapheresis to reduce circulating absolute lymphoblast count to =\\\u003C 10,000\u002FuL or prevent complications related to ALL are allowed but must be completed \\>= 24 hours prior to the initiation of protocol therapy.\n* COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =\\\u003C 1.\n* COHORT 2: Peripheral blood absolute lymphoblast count =\\\u003C 10,000\u002FuL (treatment allowed as above to reduce blast count to =\\\u003C 10,000\u002FuL)\n* COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens\n* COHORT 3: Diagnosis of Philadelphia chromosome\u002FBCR-ABL1-positive B-cell ALL\n* COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and\u002For leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy.\n* COHORT 3: No chronic, strong CYP3A4 inducers","ALL","18 Years",{"count":19,"type":20},84,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.",[26,27,28],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Recurrent B Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2019-05-08",{"date":37,"type":20},"2027-02-01",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",277,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100572830","phase-2-etoposide-prednisone-vincristine-cyclophosphamide-and-doxorubicin-da-epoch-with-or-without-rituximab-plus-recombinant-erwinia-asparaginase-jzp458-for-the-treatment-of-newly-diagnosed-ph-negative-b-acute-lymphoblastic-leukemia-or-t-acute-lymphoblastic-leukemia-100572830","NCT06738368","Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL\n* In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical\u002Flogistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen\n* Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)\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* Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN) (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and alanine aminotransferase \\[ALT\\]\u002Faspartate aminotransferase \\[AST\\] are ≤ 8.0 x ULN.)\n* AST (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002FALT (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT\u002FAST are ≤ 8.0 x ULN.)\n* Calculated creatinine clearance of ≥ 60 ml\u002Fmin\u002F1.73 m\\^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* 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 childbearing potential should use effective non-hormonal contraceptive methods during treatment with JZP458 and for 3 months after the last dose of study drug. Male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior systemic therapy for ALL except to control acute symptoms and\u002For leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg\u002Fm\\^2 per dose up to 2 doses and\u002For the equivalent of prednisone 50 mg\u002Fm\\^2\u002Fday for up to 2 days are permitted\n* Burkitt lymphoma\u002Fleukemia\n* Isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency\n* Known active chronic liver disease including, but not limited to, non-alcoholic steatohepatitis, cirrhosis, or non-alcoholic fatty liver disease\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* Pregnant or nursing\n\n  * Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \\[1\\] surgically sterilized, or \\[2\\] postmenopausal \\[i.e., a woman who is \\> 50 years old or who has not had menses for ≥ 1 year\\], or \\[3\\] not heterosexually active)",{"count":50,"type":20},30,[23],"This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, 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. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. 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. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.",[26,54],"T Acute Lymphoblastic Leukemia","2026-06-30",{"date":57,"type":33},"2026-07-02",{"date":59,"type":33},"2026-05-08",{"date":61,"type":20},"2028-07-30",{"name":63,"class":64},"University of Washington","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":65},"100161234","phase-1-inotuzumab-ozogamicin-and-combination-chemotherapy-in-treating-patients-with-acute-lymphoblastic-leukemia-100161234","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.",{"count":74,"type":20},276,[76,23],"PHASE1","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.",[79,26,80,81,82,27,83,28,84],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","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 Burkitt Lymphoma","Refractory Burkitt Lymphoma","2026-06-22",{"date":87,"type":33},"2026-06-23",{"date":89,"type":33},"2011-08-26",{"date":91,"type":20},"2027-12-25",{"name":93,"class":64},"M.D. Anderson Cancer Center",{"id":95,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":24,"conditions":98,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":103,"locationsCount":74},"100342529",{"count":19,"type":20},[23],[26,27,28],"2026-06-19",{"date":87,"type":33},{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100642839","phase-2-testing-blinatumomab-with-or-without-revumenib-in-patients-with-b-cell-acute-lymphoblastic-leukemia-with-a-genetic-change-requiring-more-treatment-100642839","NCT07636564","Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment","A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)\u002F Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)","Inclusion Criteria:\n\n* COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation\n* COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \\\u003C 5%\n* COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)\n\n  * Participants must not be known not to have trackable clones by clonoSEQ\n  * Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment\n* COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage\n* COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)\n* COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)\n\n  * Participants with either B or T-cell subtypes of ALL are permitted on Cohort B\n  * Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)\n* COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction\u002Fconsolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \\\u003C 18 years of age, enrollment must occur after induction therapy\n* COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction\u002Fconsolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications\n* COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies\n* COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below\n\n  * Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy\n* COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL\n* COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit\n* COHORT A: Participant must have Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky\u002FKarnofsky performance status scores of 50-100\n* COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT A: Absolute neutrophil count ≥ 1 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)\n* COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)\n* COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT A: Adequate renal function for participants \\\u003C 18 years of age is defined as:\n\n  * A GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods:\n\n    * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009)\n    * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)\n* COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as \\> 450 msec on screening electrocardiogram (EKG) prior to registration\n* COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement\n* COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator\n* COHORT A: Participants must not have clinically significant autoimmune disease\n* COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric\u002Fgastrostomy (NG\u002FG)-tube is acceptable as long as oral solution is used\n* COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:\n\n  * Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)\n\n    * Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1\n  * Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors\n* COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* COHORT B: Participant must be ≥ 55 years old at the time of registration\n* COHORT B: Participant must have Zubrod\u002FECOG performance status of 0-2\n* COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT B: GFR ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT B: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN\n* COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)\n* COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and\u002For methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy\n* COHORT B: Participants must not have an active uncontrolled infection\n* COHORT B: Participants must not have prolonged QTcf defined as \\> 450 msec participants on screening EKG prior to registration\n* COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain\u002Feye involvement or hypothalamic syndrome\n* COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG\u002FG-tube is acceptable as long as oral solution is used\n* COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n  * This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation","1 Year",{"count":113,"type":20},90,[23],"This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone 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. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. 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. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, 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. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.",[117,118,26,54],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-06-03",{"date":122,"type":33},"2026-06-09",{"date":124,"type":20},"2026-10-14",{"date":126,"type":20},"2032-04-16",{"name":128,"class":129},"SWOG Cancer Research Network","NETWORK",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":65},"100636343","phase-2-full-course-immunotherapy-combined-with-chemotherapy-in-newly-diagnosed-b-cell-acute-lymphoblastic-leukemia-100636343","NCT07564453","Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia","FLOW","Inclusion Criteria:\n\n1. Age ≥15 years and ≤65 years.\n2. Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%\n3. De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days)\n4. ECOG performance status score 0-3.\n5. Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded).\n6. Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL\u002Fmin\n7. Able to understand and voluntarily participate in the study, and provide written informed consent\n\nExclusion Criteria:\n\n1. Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL\n2. T-cell acute lymphoblastic leukemia\n3. Mature B-cell leukemia\u002Flymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion\n4. Acute mixed phenotype acute leukemia (MPAL)\n5. Central nervous system (CNS) leukemia\n6. HIV infection\n7. Positive HBV-DNA or HCV-RNA\n8. New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator\n9. Pregnant or lactating patients\n10. Patients who refuse to enroll in the study","15 Years","65 Years",{"count":140,"type":20},101,[23],"This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a \"reduced-dose chemotherapy + full-course immunotherapy\" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A\u002FB) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy.\n\nThe primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity.\n\nThe trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .",[26],[26,145],"Blinatumomab","2026-04-26",{"date":148,"type":33},"2026-05-04",{"date":150,"type":33},"2025-04-01",{"date":152,"type":20},"2028-06-30",{"name":154,"class":64},"The First Affiliated Hospital of Soochow University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100586673","phase-2-asparaginase-erwinia-chrysanthemi-with-chemotherapy-for-the-treatment-of-high-risk-adults-with-newly-diagnosed-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-100586673","NCT06918431","Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed ALL or LBL","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria\n\n  * Both B- and T-cell phenotypes are allowed.\n* CD20+ patients only: White blood cell count less than 25 x 10\\^9\u002FL prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)\n\n  * Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)\n\n  * Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)\n\n  * Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)\n* Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy\n* Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody \\[HBc\\] negative) for CD20+ patients only\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose\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* Leukemia-based therapy with chemotherapy with the exception of:\n\n  * Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study\n  * Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed\n* Received previous treatment with any other asparaginase formulation\n* Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab\n* Known presence of Philadelphia chromosome positive (Ph+; t\\[9;22\\])\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll\n* Parenchymal central nervous system (CNS) involvement\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment\n* History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)\n* Participants with history of grade ≥ 3 pancreatitis\n* History of alcohol overuse if deemed relevant in investigator opinion\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Uncontrolled active infection\n* Clinically significant uncontrolled illness\n* Other active malignancy\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)","54 Years",{"count":164,"type":20},53,[23],"This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi, and is used with other drugs in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. 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. 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. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. It is a type of anthracycline antibiotic and a type of topoisomerase inhibitor. Dexamethasone 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. Giving asparaginase Erwinia chrysanthemi with induction chemotherapy followed by consolidation chemotherapy may be safe, tolerable, and\u002For effective in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma.",[26,168],"Lymphoblastic Lymphoma","2026-03-16",{"date":171,"type":33},"2026-03-17",{"date":173,"type":33},"2025-10-10",{"date":175,"type":20},"2029-03-30",{"name":177,"class":64},"City of Hope Medical Center",8]