Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients...
Acute Leukemia of Ambiguous LineageAcute Lymphoblastic Leukemia7 moreThis phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.
Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations
Acute AppendicitisThe overall project goal is to conduct a pilot randomized clinical trial of operative (laparoscopic appendectomy) vs nonoperative (antibiotic) management of uncomplicated acute appendicitis for vulnerable populations. Specifically, the elderly, non-English speakers, and those with economic vulnerability (low socioeconomic status and/or manual labor jobs without a non-weight lifting aspect), are three vulnerable population subsets identified. This pilot trial will provide critical preliminary data for planning and conducting a larger multi-site randomized trial.
VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Acute Kidney InjuryRenal Insufficiency6 moreA quasi experimental study that aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory...
Recurrent Acute Leukemia of Ambiguous LineageRecurrent Acute Lymphoblastic Leukemia4 moreThis phase II trial tests the safety and best dose of revumenib when given together with chemotherapy, and how well the treatment regimen works for infants and young children with leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in test tubes and animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine and cytarabine 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. This trial is being done to find out if the combination of revumenib and chemotherapy may help to treat the cancer cells better than either treatment alone.
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
Acute LeukemiaAllogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative...
Acute LeukemiaMyelodysplastic Syndromes1 moreHEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies. HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse: tumor samples: marrow aspiration, blood sampling. non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.
Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis
Acute AppendicitisAppendicitis Perforated1 moreThe aim of this study is to evaluate the safety and efficacy of outpatient management of complicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype...
Acute Lymphoblastic LeukemiaMixed Phenotype Acute LeukemiaThis study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis
Chronic BronchitisThe aim of the study is to determine the importance and impact of resistive breathing techniques versus inspiratory hold techniques in patients with chronic bronchitis and specially to find out if there are any changes seen in results measured via the incentive spirometer.
Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia...
Acute LeukemiaGoal: This study is a randomized phase II interventional study. The purpose of this study is to see if addition of oral rifaximin tablets during allogeneic stem cell transplant can improve the quality of gut microbiome and reduce chances of death, infections and graft versus host disease (GVHD) post-transplant. The study objectives are as follows: Primary Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls. Secondary Objectives: a. To determine non-relapse mortality at 1-year post transplant in patients who receive peri-transplant transplant rifaximin and compare it with controls. b. To compare the incidence of severe GVHD in patients who receive peri-transplant rifaximin with the controls. c. To determine impact of gut decontamination with rifaximin on incidence of MDR sepsis and usage of higher antibiotics (e.g. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMT. d. To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post-transplant and cytokine profile. Exploratory objective: To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant whenever biopsy is done, to correlate the impact of microbiome on gut immunity. Intervention: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to standard of care post-transplant treatment. Comparator Agent: Standard of care treatment including standard anti GVHD measures, antibiotic support and transfusions as needed.