AC220 for Children With Relapsed/Refractory ALL or AML
Lymphoblastic LeukemiaAcute4 moreThis is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).
CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related...
LeukemiaAcute Lymphoblastic3 moreStudy Description: This retrospective protocol focuses on characterizing clinical outcomes and toxicities following CAR T-cell therapy. Objectives: Primary To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab To retrospectively evaluate outcomes following CAR T-cell therapy across children and young adults with B-ALL Secondary To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Study Population and Source of Data: Subjects who were less than < 25 years of age at the time of diagnosis and received a CAR T-cell product for B-ALL.
A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301...
Acute BronchitisAcute Exacerbations of Chronic BronchitisThe purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis. - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum
Cancer Stem Cells in Acute Leukemia
Acute LeukemiaDescriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.
Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)
Unstable AnginaMyocardial Infarction1 moreThe purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A): Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.
Cytogenetic Studies in Acute Leukemia and Multiple Myeloma
Acute LeukemiaAcute Lymphoblastic Leukemia2 moreChromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.
A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody...
Pulmonary DiseaseChronic Obstructive2 moreTo determine if ABX-IL8 will improve shortness of breath.
The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis...
AppendicitisOther and Unspecified Acute Appendicitis3 moreThis study focuses on the use of contrast enhanced low-dose CT imaging as a modality to differentiate between uncomplicated and complicated acute appendicitis. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.
Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis...
COPDChronic BronchitisThe purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic...
Lung DiseasesBronchitis1 moreMoxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.