[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-b-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-b-acute-lymphoblastic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,72,82,106,129,155,194,216],{"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":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"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":50,"type":20},276,[52,23],"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.",[55,26,56,57,58,27,59,28,60],"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":63,"type":33},"2026-06-23",{"date":65,"type":33},"2011-08-26",{"date":67,"type":20},"2027-12-25",{"name":69,"class":70},"M.D. Anderson Cancer Center","OTHER",1,{"id":73,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":24,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":81,"locationsCount":50},"100342529",{"count":19,"type":20},[23],[26,27,28],"2026-06-19",{"date":63,"type":33},{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100404441","phase-2-a-study-to-compare-blinatumomab-alone-to-blinatumomab-with-nivolumab-in-patients-diagnosed-with-first-relapse-b-cell-acute-lymphoblastic-leukemia-b-all-100404441","NCT04546399","A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >\u002F= 1 to \u003C 31 Years Old With First Relapse","Inclusion Criteria:\n\n* Patients must be \\>= 1 and \\\u003C 31 years at time of enrollment\n* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:\n\n  * Isolated bone marrow relapse\n  * Isolated central nervous system (CNS) (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n  * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testes\n* Patients with Down syndrome (DS) are eligible in the following categories:\n\n  * Isolated bone marrow relapse\n  * Combined bone marrow with CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n\n  * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression\n  * Patients must not have had a prior hematopoietic stem cell transplant\n  * A single intrathecal chemotherapy at the time of relapse will be allowed. If \\\u003C 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted\n  * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and\u002For hydroxyurea only) is permissible\n\n    * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \\>= 30,000\u002Ful at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no \"washout\" is required\n    * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \\\u003C 30,000\u002Ful at the time of enrollment must be given a 24 hour \"washout\" before starting immunotherapy\n  * Note: There is no waiting period or \"washout\" for patients who relapse while receiving upfront therapy\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (within 7 calendar days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n    * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: 1.7 (male), 1.4 (female)\n\n      * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with B-lymphoblastic lymphoma (B-LLy)\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)\n* Patients with mixed phenotype acute leukemia (MPAL)\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype\n* Patients with active, uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment\n  * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.\n  * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \\> 48 hours\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\n  * Active viral or protozoal infection requiring IV treatment\n* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.\n* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* Patients with an active known\u002Fsuspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Patients with DS patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are not eligible\n\n  * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab\n* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose","1 Year","30 Years",{"count":92,"type":20},461,[23],"This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.",[96,27],"Down Syndrome","2026-06-11",{"date":99,"type":33},"2026-06-12",{"date":101,"type":33},"2020-12-17",{"date":103,"type":20},"2028-06-30",{"name":39,"class":40},225,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":71},"100633887","phase-1-pomalidomide-after-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-cd19-b-cell-leukemia-or-lymphoma-100633887","NCT07532525","Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma","A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed\u002FRefractory CD19+ B-Cell Leukemias and Lymphomas","Inclusion Criteria:\n\n* Subject must have had a histologically or cytologically confirmed R\u002FR CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R\u002FR CD19+ Bcell leukemias and lymphomas.\n* Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.\n* \\>= 18 years in age at time of enrollment\n* Subject is able to swallow pills\u002Ftablets\n* Karnofsky or Lansky performance score of \\>= 50%\n* Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (granulocyte colony stimulating factor allowed)\n* Platelets \\>= 50,000\u002Fmm\\^3 (transfusion independent for \\>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \\[thrombopoietin (TPO) mimetics allowed\\])\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) per institution\n* Alanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) =\\\u003C 3 x institutional ULN per institution\n* Serum albumin \\>= 2.0 g\u002FdL\n* Creatinine clearance (Cockcroft-Gault equation) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n* Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program\n* Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide\n\nExclusion Criteria:\n\n* Patients with known progressive or refractory disease.\n* The following transplant or CAR T-related events are excluded:\n\n  * Active grade \\>= 2 acute or chronic graft versus host disease (GVHD)\n  * Active cytokine release syndrome (CRS) grade \\>= 2\n  * Active immune effector cell associated neurotoxicity (ICANS) grade \\>= 2\n* Subject receiving \\>= 0.25 mg\u002Fkg\u002Fday of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine.\n* Patient who smokes cigarettes.\n* Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS\u002FICANS is allowed within the prior 28 days\n* Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment\n* Stem cell transplant or rescue following most recent CD19CART therapy\n* History of allergic reactions to pomalidomide or any of the excipients and any similar compounds\n* Intercurrent illness or conditions:\n\n  * Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed\n  * Active grade \\>= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded\n  * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded\n  * History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment\n* Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug\n* HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay",{"count":114,"type":20},12,[52],"This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia\u002Flymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.",[27,118,28,119],"Recurrent B-Cell Non-Hodgkin Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma","2026-06-08",{"date":122,"type":33},"2026-06-09",{"date":124,"type":20},"2026-07-01",{"date":126,"type":20},"2028-08",{"name":128,"class":70},"University of Michigan Rogel Cancer Center",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":154},"100284363","phase-2-inotuzumab-ozogamicin-in-treating-younger-patients-with-b-lymphoblastic-lymphoma-or-relapsed-or-refractory-cd22-positive-b-acute-lymphoblastic-leukemia-100284363","NCT02981628","Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia","A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* Patients must be \\>= 1 year and \\\u003C 22 years of age at the time of enrollment\n* Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with \\>= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease\n\n  * NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study\n* Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing \\>= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method\n* Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local\u002Finstitutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin \\[PE\\] is strongly recommended)\n\n  * In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000\u002FuL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen\n* Patients with one of the following:\n\n  * Second or greater relapse;\n  * Primary refractory disease with at least 2 prior induction attempts;\n  * First relapse refractory to at least one prior re-induction attempt\n  * Any relapse after HSCT (Cohort 1 ONLY)\n\nPatients with Down syndrome are eligible ONLY for Cohort 1 with:\n\n* Any of above disease status, OR\n* First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy\n\n  * Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)\n  * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =\\\u003C grade 2 or lower per the inclusion\u002Fexclusion criteria prior to entering this study. Apply to Cohort 2:\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.\n\n  * A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and\u002For methotrexate).\n  * A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and\u002For cytarabine within 7 days prior to enrollment\n  * \\>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, \\>= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.\n\n    * Note: Cytoreduction with hydroxyurea must be discontinued \\>= 24 hours prior to the start of protocol therapy.\n* Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment.\n* Anti-cancer agents that are antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion\u002Fexclusion criteria.\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy\u002Fcytoreduction.\n* Radiotherapy: \\>= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); \\>= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if \\>= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; \\>= 6 weeks must have elapsed if other substantial bone marrow irradiation was given.\n* Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.\n* Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion\n\n  * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n  * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * A serum creatinine based on age\u002Fsex as follows:\n* 1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL (both male and female)\n* 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL (both male and female)\n* 6 to \\\u003C 10 years: maximum serum creatinine 1 mg\u002FdL (both male and female)\n* 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL (both male and female)\n* 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n* \\>= 16 years: maximum serum creatinine 1.7 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n\n  * Direct bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age, and\n  * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U\u002FL\n\nExclusion Criteria:\n\n* Patients with any prior history of SOS irrespective of severity\n* Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse\n* Patients who have been previously treated with inotuzumab ozogamicin\n* Patients who have previously received HSCT (Cohort 2 only)\n* Patients with Down syndrome (Cohort 2 only)\n* History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study\n\n  * Note: Patients with history of allergy to pegaspargase\u002Fcalaspargase pegol are eligible for enrollment on Cohort 2 if Erwinia formulation of asparaginase can be obtained\n* Patients with active optic nerve and\u002For retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement\n* Patients who are currently receiving another investigational drug\n* Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)\n* Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications\n* Patients who are currently receiving or plan to receive corticosteroids except as described below\n\n  * Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement\u002Fstress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications\n* Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient\n* Patients who have an active uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment;\n  * Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\n  * Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline\n  * Active viral or protozoal infection requiring IV treatment\n* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome\n* There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose\n\n  * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment\n  * Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin\n  * Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin\n  * Lactating females are not eligible unless they agree not to breastfeed their infants","21 Years",{"count":138,"type":20},80,[23],"This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.",[27,142,28,143],"Recurrent B Lymphoblastic Lymphoma","Refractory B Lymphoblastic Lymphoma","2026-06-03",{"date":146,"type":33},"2026-06-05",{"date":148,"type":33},"2017-06-19",{"date":150,"type":20},"2026-12-31",{"name":152,"class":153},"Children's Oncology Group","NETWORK",157,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100471377","phase-1-genetically-engineered-cells-anti-cd19cd20cd22-car-t-cells-for-the-treatment-of-relapsed-or-refractory-lymphoid-malignancies-100471377","NCT05418088","Genetically Engineered Cells (Anti-CD19\u002FCD20\u002FCD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies","Phase I Clinical Trial of Anti-CD19\u002F20\u002F22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, B-Prolymphocytic Leukemia)","Inclusion Criteria:\n\n* Adult subjects with relapsed or refractory non-Hodgkin lymphoma with lesions =\\\u003C 5 cm, indolent lymphomas, chronic lymphocytic leukemia without Richter's transformation, or B-prolymphocytic leukemia (Cohort A)\n* OR adult subjects with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions \\> 5 cm and\u002For lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells, B-Prolymphocytic leukemia with lesions \\> 5 cm (not including splenomegaly (Cohort B).\n* OR Pediatric subjects with Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma\n* Subjects must have been treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen. B-PLL is defined as having greater than 55% prolymphocytes in the peripheral blood\n* Subjects with relapsed\u002Frefractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor and venetoclax\n* Subjects with refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant\n* Subjects with relapsed\u002Frefractory B-prolymphocytic leukemia who received at least 1- 2 prior lines of appropriate therapy and who have failed or are ineligible for allogeneic stem cell transplant\n* Subjects with relapsed\u002Frefractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy or who have failed or are ineligible for allogeneic stem cell transplant.\n* The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and\u002For CD20 and\u002For CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.\n* Patients who received blinatumomab or inotuzumab are eligible.\n* Patients who received prior CAR T-cells are eligible, (commercial CD 19 CAR-T cells or dual CAR-T cells), if it has been at least 30 days since previous CAR T cell therapy and \\\u003C5% of circulating levels of CD3+ cells express the prior CAR by flow cytometry.\n* Age \\>= 2 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2. For patients \\\u003C 16 years, Performance score Lansky \\>= 50\n* Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal for age\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3 X institutional upper limit of normal for age\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 X institutional upper limit of normal for age\n* Creatinine clearance more than or equal to 50 ml\u002Fmin calculated by the Cockcroft - Gault formula, or by Schwartz formula for patients \\\u003C 18 years\n* Subjects must have adequate pulmonary function as defined as pulse oximetry \\>= 92% on room air\n* Subjects must have adequate cardiac function as defined as left ventricular ejection fraction \\>= 40% in the most recent echocardiogram\n* Absolute lymphocyte count \\> 100\u002FuL\n* Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the Anti-CD19\u002F20\u002F22 CAR-T cell infusion\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive s that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n* With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the Anti-CD19\u002F20\u002F22 CAR-T cell infusion. Men must refrain from donating sperm during this same period\n* With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the human anti-CD19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Autologous transplant within 6 weeks of planned CAR-T cell infusion\n* Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents. Patients with live vaccines given 28 days prior to lymphodepletion (LD) chemotherapy will be excluded\n* Active graft versus host disease\n* Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases\u002Fcentral nervous system (CNS) disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 90 days prior to registration\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast). 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 (e.g.\n\nLow Gleason score prostate Cancer)\n\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection\n* Human immunodeficiency virus (HIV)-seropositive patients are allowable, however must be on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment to be eligible for this trial\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Patients with a positive hepatitis B core antibody or surface antigen are at high risk for hepatitis B virus (HBV) reaction and will require entecavir\u002Ftenofivir prophylaxis or serial hepatitis B (Hep B) PCR monitoring at the direction of an infectious disease specialist. Duration of prophylaxis to correspond with detection of Anti-CD19\u002F20\u002F22 CAR T cells\u002Fviral vector copies in serum or continued evidence of B-cell aplasia such as reduced intravenous immunoglobulin therapy (IVIG) levels. No antiviral prophylaxis is indicated with hepatitis C positivity with negative PCR\n* Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months\n* Live vaccines given in 28 days prior to lymphodepleting chemotherapy","2 Years",{"count":164,"type":20},54,[52],"This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19\u002FCD20\u002FCD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19\u002FCD20\u002FCD22 which are found on the surface of cancer cells. Anti-CD19\u002FCD20\u002FCD22 CAR T-cells can recognize CD19\u002FCD20\u002FCD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.",[168,27,169,170,171,172,173,174,175,28,176,177,178,179,180,181,182,183],"Recurrent Acute Lymphoblastic Leukemia","Recurrent B-Cell Prolymphocytic Leukemia","Recurrent Chronic Lymphocytic Leukemia","Recurrent High Grade B-Cell Lymphoma","Recurrent Indolent Non-Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory B-Cell Prolymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory High Grade B-Cell Lymphoma","Refractory Indolent Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","Refactory Childhood Acute Lymphoblastic Leukemia","Refractory Childhood Non-Hodgkin Lymphoma","2026-05-27",{"date":186,"type":33},"2026-05-29",{"date":188,"type":33},"2022-06-30",{"date":190,"type":20},"2027-07-01",{"name":192,"class":70},"Sumithira Vasu",2,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":136,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":71},"100575876","phase-1-cd19-cd22-bispecific-chimeric-antigen-receptor-car-t-cell-therapy-for-pediatric-patients-with-acute-lymphoblastic-leukemia-100575876","NCT06777979","CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia","CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)","Collection and Manufacturing Eligibility\n\nInclusion Criteria:\n\n* Age \\\u003C21 years old\n* Relapsed\u002Frefractory CD19- and\u002For CD22-positive acute leukemia defined as:\n\n  \\*CD19 and\u002For CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy\n  * Second or greater relapse\n  * Any relapse after allogeneic HCT\n  * Refractory disease (primary or in relapse) despite therapy designed to induce remission\n* Estimated life expectancy of \\> 12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)\n* For females of childbearing age:\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Known contraindication to receiving protocol defined lymphodepleting\n* chemotherapy regimen\n* History of hypersensitivity reaction to murine protein-containing products\n\nTreatment Eligibility\n\nInclusion Criteria:\n\n* Age \\\u003C 21 years old\n* Detectable disease in the bone marrow\n* Estimated life expectancy of \\> 8 weeks\n* Karnofsky or Lansky (age-dependent) performance score \\> 50 (Appendix A)\n* Adequate cardiac function defined as left ventricular ejection fraction \\>40%, or shortening fraction \\> 25%\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function defined as creatinine clearance or radioisotope GFR \\>50 mL\u002Fmin\u002F1.73m2 (GFR \\>40 mL\u002Fmin\u002F1.73m2 if \\\u003C2 years of age)\n* Adequate pulmonary function defined as forced vital capacity (FVC) \\>50% of predicted value; or pulse oximetry \\>92% on room air\n* Total bilirubin \\\u003C 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 5 times the upper limit of normal for age\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion\n* For females of childbearing age:\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n  * If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Known contraindication to receiving protocol defined lymphodepleting\n* chemotherapy regimen\n* History of hypersensitivity reactions to murine protein-containing products\n* Severe, uncontrolled bacterial, viral or fungal infection\n* Active CNS-3 disease\n* Evidence of active, uncontrolled neurologic disease",{"count":202,"type":20},30,[52],"This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells.\n\nPrimary Objective:\n\nTo determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent\u002Frefractory CD19- and\u002For CD22-positive leukemia.\n\nSecondary Objective:\n\nTo evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.",[206,168,27],"Acute Lymphoblastic Leukemia","2026-05-18",{"date":209,"type":33},"2026-05-19",{"date":211,"type":33},"2025-04-28",{"date":213,"type":20},"2031-01",{"name":215,"class":70},"St. Jude Children's Research Hospital",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":71},"100603244","phase-1-recombinant-erwinia-asparaginase-and-venetoclax-in-combination-with-blinatumomab-for-the-treatment-of-relapsed-or-refractory-cd19-positive-b-cell-acute-lymphoblastic-leukemia-100603244","NCT07133997","Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age between 12 and 55\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70\n* Patients with relapsed or refractory (R\u002FR) CD19 positive (+) B-cell acute lymphoblastic leukemia (B-ALL) according to World Health Organization (WHO) criteria\n\n  * Greater than or equal to 5% blasts in the bone marrow\n* White blood cell count less than 25 x 10\\^9\u002FL prior to initiation of venetoclax. (within 14 days prior to day 1 of protocol therapy) Cytoreduction with hydroxyurea, steroid or a single dose of cyclophosphamide 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 underlying leukemia, ≤ 3 x ULN)\n* Prothrombin time (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Partial thromboplastin time (PTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 14 days prior to day 1 of protocol therapy) (Unless it is related to underlying leukemia, then AST ≤ 5 x ULN)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 14 days prior to day 1 of protocol therapy) (Unless it is related to underlying leukemia, then ALT ≤ 5 x ULN)\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* Left ventricular ejection fraction (LVEF) ≥ 50% (within 14 days prior to day 1 of protocol therapy)\n\n  * Note: Echocardiogram to be performed within 42 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 method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months 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* Allogeneic hematopoietic cell transplantation (HCT) within 8 weeks prior to the start of protocol-specific therapy. Subjects must be off all immunosuppression for ≥ 2 weeks\n* Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy with the exception of: intrathecal chemotherapy and\u002For low-dose maintenance therapy (e.g. vina alkaloids, mercaptopurine, methotrexate, or hydroxyurea etc)\n* Strong and moderate CYP3A4 inducers and strong CYP3A inhibitors within 7 days prior to day 1 of protocol therapy\n* Foods\u002Fsupplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as grapefruit, Seville oranges, starfruit and St. John's wort) within 3 days prior to initiation of and during study treatment\n* Immunotherapy (e.g. rituximab) within 4 weeks before the start of protocol-specified therapy. Prior failed CD19-directed therapy such as prior blinatumomab or CD19-directed chimeric antigen receptor (CAR)-T cells will be allowed if treatment ended \\> 4 weeks prior to start of protocol-specific therapy and there is demonstrated continued CD19+ expression\n* Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment\n* Patients with any prior intolerance leading to discontinuation of pegylated (PEG)-asparaginase due to grade 3 or more pancreatitis or central nervous system thrombosis requiring anticoagulant treatment attributed to the PEG-asparaginase\n* Active ALL in the central nervous system (CNS): Presence of \\> 5 white blood cells (WBC) per cubic millimeter in the cerebrospinal fluid (CSF) with lymphoblasts present (confirmed by CSF analysis) and\u002For clinical signs of CNS leukemia. If CSF leukemia is present, subjects will need to receive intrathecal chemotherapy and have documented negative CSF prior to enrollment\n* Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication\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's opinion\n* Known hypersensitivity to blinatumomab\u002F recombinant Erwinia asparaginase or to any component of the product formulation, otherwise prior treatment with single agent blinatumomab is allowed\n* Uncontrolled active infection\n* Clinically significant uncontrolled illness or cirrhosis\n* Other active malignancy (except superficial skin cancers squamous cell carcinoma \\[SCC\\]\u002Fbasal cell carcinoma \\[BCC\\], early-stage malignancies ductal carcinoma in-situ \\[DCIS\\] status post \\[s\u002Fp\\] excision or elevated prostate specific antigen \\[PSA\\])\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)","12 Years","55 Years",{"count":226,"type":20},26,[52],"This phase I\u002FIb trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab and how well the combination works in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). 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. It is used 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a drug used to treat certain types of B-cell acute lymphoblastic leukemia that are CD19 positive (expresses the protein CD19). 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. Blinatumomab is a type of bispecific T-cell engager. Giving asparaginase Erwinia chrysanthemi and venetoclax in combination with blinatumomab may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory ALL.",[27,28],"2026-04-01",{"date":232,"type":33},"2026-04-07",{"date":234,"type":20},"2026-06-01",{"date":236,"type":20},"2028-06-01",{"name":238,"class":70},"City of Hope Medical Center"]