Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies
ColitisMucositis1 moreIn patients with acute myelogenous leukemia (AML), a high proportion will suffer from inflammation of the large bowel (colitis) during their intensive treatment. As there is no standard treatment available for this potentially lifethreatening condition, the investigators focus on the role of parenteral nutrition which these patients inevitably require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard nutrition in patients with chemotherapy-induced colitis. In this small phase II study, the investigators address the effectiveness of this approach to reduce the incidence and severity of colitis in AML patients.
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic...
LeukemiaMultiple MyelomaThe purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.
A Study of LNK01002 in Patients With Primary or Secondary Myelofibrosis,Polycythemia Vera or Acute...
Acute Myeloid LeukemiaPrimary Myelofibrosis3 moreThis multicenter, open-label, phase 1 study designed to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (PMF), or MF due to polycythemia vera (PV-MF), or essential thrombocythemia (ET-MF), polycythemia vera (PV), or with acute myeloid leukemia (AML).
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological...
Relapsed or Refractory Multiple MyelomaHematological MalignancyThis is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with relapsed or refractory multiple myeloma and other hematological malignancies
A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)
Hematological InfectionMDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was previously shown, that intestinal colonization with extended-spectrum β-lactamases (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et al., 2016]. To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy and safety of selective intestinal decolonization strategies in high-risk patients with haematological malignancies. Possible decolonization of MDR gram-negative bacteria in haematological patients could be important for the patient by reducing the risk of infection and for the community by reducing the risk of transmission. The purpose of the proposed study is to assess the efficacy and safety of selective intestinal decolonization of MDR gram-negative bacteria with oral administration of Colistimethate sodium in high risk patients with haematological malignancies.
Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory...
Hematologic MalignancyThe goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied.
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells...
Hematologic DiseasesHematologic MalignanciesThe purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological...
Hematological MalignanciesThe purpose of the study is to determine the safety and tolerability of RGB-286638, a novel, multi-targeted kinase inhibitor, administered to patients with selected, relapsed or refractory hematological malignancies.
Study to Investigate AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic...
CancerThis is a two-part study in subjects with hematologic malignancies designed to find the maximum tolerated dose (MTD) of GSK690693 (Part 1). Part 2 is designed to determine the efficacy of GSK690693 in a subset of subjects with hematologic malignancies.
Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies
Hematologic MalignanciesThis is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least one dose of study drug will be evaluable for safety. Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response. Each subject will receive the same dose of 750mg po daily at the study entry. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision. Intrapatient dose reductions will be allowed for adverse events. This is a multicenter study with Duke as the lead site. Blood and tissue samples, will be collected and used for exploratory analysis.