Editing Trials (Motol University Hospital)

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'''NCTID''': NCT02447666 
 '''Title''': Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML) 
 '''Study Summary''': Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).  Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission \[CR\], partial remission \[PR\], or marrow CR; JMML: either clinical complete remission \[cCR\] or clinical partial remission \[cPR\]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data.  Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.  Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product \[IP\]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped. 
 '''Sponsor''': Celgene 
 '''Intervention''': Azacitidine 
 '''Start Date''': 2015-09-15 
 '''Last Updated''': 2019-07-11 
 '''Number of Patients''': 28 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Myelodysplastic Syndrome 
'''NCTID''': NCT04793919 
 '''Title''': Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia 
 '''Study Summary''': The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age. 
 '''Sponsor''': Associazione Italiana Ematologia Oncologia Pediatrica 
 '''Intervention''': Mylotarg 
 '''Start Date''': 2019-10-09 
 '''Last Updated''': 2022-08-10 
 '''Number of Patients''': 89 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Acute Promyelocytic Leukemia 
'''NCTID''': NCT00547651 
 '''Title''': AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy 
 '''Study Summary''': This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. 
 '''Sponsor''': Celgene 
 '''Intervention''': Amrubicin 
 '''Start Date''': 2007-09-01 
 '''Last Updated''': 2019-11-06 
 '''Number of Patients''': 637 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Small Cell Lung Cancer 
'''NCTID''': NCT04785547 
 '''Title''': ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT 
 '''Study Summary''': A phase II trial of continuous intravenous infusion of Blincyto given over a 28-day cycle. Starting day for patients who are MRD-positive before HSCT is between day +60 and day +100 and for patients who become MRD-positive post HSCT it is between day +60 and day +360 post HSCT.  Patients will be evaluated for response at day +28 (+4 days) (bone marrow morphology and MRD analysis - defined by PCR/FLOW-techniques) after start of Blincyto-treatment at the end of first Blincyto infusion and at regular post-TX-checks (according to FORUM: days +28, +60, +100, +180 and +360 after HSCT).  The dose of Blincyto used in this trial will be 15 mcg/m2/day for 28 days 
 '''Sponsor''': Prof. Christina Peters 
 '''Intervention''': Blinatumomab 
 '''Start Date''': 2020-12-17 
 '''Last Updated''': 2021-03-08 
 '''Number of Patients''': 32 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': ALL, Childhood 
'''NCTID''': NCT02218047 
 '''Title''': AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. 
 '''Study Summary''': Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur.  The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm is receiving best available therapy as selected by the investigator. Response to the treatment is measured by several blood parameters as well as size of the spleen.  Interferon-alpha has been shown to be effective in controlling the blood parameters by immunologically influencing the blood building cells. This can lead to a suppression of the disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism it is possible that Interferon-alpha can avoid long-term damaging effects of the disease. 
 '''Sponsor''': AOP Orphan Pharmaceuticals AG 
 '''Intervention''': Pegylated-Proline-interferon alpha-2b 
 '''Start Date''': 2014-11 
 '''Last Updated''': 2021-06-01 
 '''Number of Patients''': 170 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Polycythemia Vera 
'''NCTID''': NCT05035615 
 '''Title''': Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer 
 '''Study Summary''': This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis. 
 '''Sponsor''': Becton, Dickinson and Company 
 '''Intervention''': IUO Acute Leukemia Panel 
 '''Start Date''': 2021-11-02 
 '''Last Updated''': 2023-10-30 
 '''Number of Patients''': 200 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Acute Leukemia 
'''NCTID''': NCT00646854 
 '''Title''': Alemtuzumab and CHOP in T-cell Lymphoma 
 '''Study Summary''': The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma. 
 '''Sponsor''': Aarhus University Hospital 
 '''Intervention''': CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab 
 '''Start Date''': 2008-06 
 '''Last Updated''': 2019-03-01 
 '''Number of Patients''': 136 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Lymphoma, T-Cell, Peripheral 
'''NCTID''': NCT01356290 
 '''Title''': Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT 
 '''Study Summary''': Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined. 
 '''Sponsor''': Medical University of Vienna 
 '''Intervention''': Bevacizumab 
 '''Start Date''': 2014-04 
 '''Last Updated''': 2023-04-21 
 '''Number of Patients''': 100 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Medulloblastoma Recurrent 
'''NCTID''': NCT01435356 
 '''Title''': Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy 
 '''Study Summary''': The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months. 
 '''Sponsor''': European Association of Urology Research Foundation 
 '''Intervention''': recMAGE-A3 + AS15 ASCI 
 '''Start Date''': 2011-08 
 '''Last Updated''': 2019-01-09 
 '''Number of Patients''': 83 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Urinary Bladder Neoplasms