[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-burkitt-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-burkitt-lymphoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100161234","phase-1-inotuzumab-ozogamicin-and-combination-chemotherapy-in-treating-patients-with-acute-lymphoblastic-leukemia-100161234",false,"NCT01371630","Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia","Phase I\u002FII Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and\u002For 1 dose of anthracycline or alkylating agents) are allowed.\n2. Patients unfit ≥ 18 - \\\u003C 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.\n\n   These patients are defined as having at least one of the below comorbidities:\n   1. ECOG performance status ≥ 2\n   2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)\n   3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)\n   4. Creatinine clearance \\\u003C 45 mL\u002Fmin, and\n   5. Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal\n\n   \u003C!-- -->\n\n   1. If they achieved CR, they are assessable only for event-free and overall survival, or\n   2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.\n4. Zubrod performance status 0-3.\n5. Adequate liver function (bilirubin \\\u003C 1.95 mg\u002FdL and SGPT or SGOT \\\u003C 3 x upper limit of normal \\[ULN\\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \\\u003C 2.6 mg\u002FdL and creatinine \\\u003C 3 mg\u002FdL.\n6. Provision of written informed consent.\n7. Patients in first remission are eligible.\n8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.\n\nExclusion Criteria:\n\n1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.\n2. Patient with active heart disease (NYHA class \\> 3 as assessed by history and physical examination).\n3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \\\u003C 40% are excluded.\n4. Patients with active hepatitis are excluded.\n5. Pregnant or breast-feeding women are excluded.","ALL","18 Years",{"count":19,"type":20},276,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.",[27,28,29,30,31,32,33,34,35],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Burkitt-Like Lymphoma With 11q Aberration","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent B Acute Lymphoblastic Leukemia","Recurrent Burkitt Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory Burkitt Lymphoma","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":40},"2011-08-26",{"date":44,"type":20},"2027-12-25",{"name":46,"class":47},"M.D. Anderson Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100296220","phase-2-combination-chemotherapy-in-treating-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-lymphoblastic-lymphoma-burkitt-lymphomaleukemia-or-double-hit-lymphomaleukemia-100296220","NCT03136146","Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma\u002FLeukemia, or Double-Hit Lymphoma\u002FLeukemia","Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)","Inclusion Criteria:\n\n* Relapsed\u002Frefractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):\n\n  * Relapsed and\u002For refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)\n  * Relapsed and\u002For refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia\u002Flymphoma or \"double-hit\" leukemia\u002Flymphoma (phase II only)\n* At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset\n* Age older than 15 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3 (There may be certain patients with performance status \\[PS\\] 3 in the context of rapidly proliferative\u002Frefractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)\n* Serum bilirubin =\\\u003C 1.5 mg\u002FdL\n* Serum glutamate pyruvate transaminase (SGPT) =\\\u003C 3 x upper limit normal (ULN), with exception for Gilbert's syndrome\n* Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL\u002Fmin\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active \\>= grade 3 peripheral neuropathy\n* Active hepatic graft-versus-host disease\n* Known positivity for hepatitis B or C\n* Pregnancy\n* Breast feeding","15 Years",{"count":58,"type":20},42,[24],"This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma\u002Fleukemia, or double-hit lymphoma\u002Fleukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[62,63,64,33,65,66,67,68,35,69,70],"Recurrent Acute Lymphoblastic Leukemia","Recurrent Adult Lymphoblastic Lymphoma","Recurrent Burkitt Leukemia","Recurrent Childhood Lymphoblastic Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Acute Lymphoblastic Leukemia","Refractory Burkitt Leukemia","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Lymphoblastic Lymphoma","2026-02-12",{"date":73,"type":40},"2026-02-17",{"date":75,"type":40},"2017-08-09",{"date":77,"type":20},"2027-08-01",{"name":46,"class":47}]