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Hematologic Diseases clinical trials

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NCT ID: NCT01790568 Completed - Clinical trials for Graft vs Host Disease

Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant

Start date: December 2014
Phase: Phase 2
Study type: Interventional

This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After completing enrollment of the planned 12 subjects, we are extending the study to an additional 25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat, the study drug, to standard medications to try to prevent or lower the risk of graft versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or marrow stem cell transplants. The transplant regimens, chosen according to current institutional policy, will depend upon the recipients underlying disease (their blood cancer or other blood disorder), previous therapy, and current health issues. GVHD prophylaxis (preventive drug intervention) will be the local institutional standard for post-transplant immunosuppression, including tacrolimus and methotrexate, plus vorinostat. Vorinostat will be given twice daily orally beginning 10 days prior to the recipient's transplant and continue for up to 100 days after transplant.

NCT ID: NCT01787552 Completed - Clinical trials for Hematologic Diseases

A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

Start date: May 8, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.

NCT ID: NCT01737554 Completed - Cancer Clinical Trials

Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents

Start date: December 2012
Phase: N/A
Study type: Observational

Catheter occlusion and dysfunction are common complications of central venous access device (CVAD) use in children with cancer and hematologic disorders. These events can lead to interruption of therapy and may require device removal and replacement. Attempts to clear occlusion can cause device fracture. There is a clear link between catheter occlusion and other serious complications including bloodstream infection and intravascular thrombosis. There is evidence that catheter occlusion or dysfunction may be preceded by subclinical catheter narrowing, which could be detected by accurate measurement of catheter resistance. This study aims to observe and describe the feasibility and results of catheter resistance monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of catheter occlusion. If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection or thrombosis.

NCT ID: NCT01670097 Completed - Solid Tumors Clinical Trials

Dexamethasone Dyspnea Study

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo. Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

NCT ID: NCT01602952 Completed - Leukemia Clinical Trials

Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI

Start date: July 2008
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated phases. Phase 1 1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects who are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or intolerant to at least one second-generation targeted anticancer agent while being resistant, suboptimal responsive, or intolerant to imatinib simultaneously. Phase 2 1. To investigate safety of oral Radotinib HCl in CML patients who are resistant or intolerable to imatinib in the chronic and accelerated phases. 2. To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCl in CML patients who are resistant or intolerable to imatinib in the chronic and accelerated phases.

NCT ID: NCT01524536 Completed - Clinical trials for Hematologic Diseases

Steroid Treatment for Hypereosinophilic Syndrome

Start date: February 16, 2012
Phase: Phase 4
Study type: Interventional

Background: - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart, nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage. Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although most people respond to prednisone, some people develop side effects from it, or do not respond very well to treatment. Better ways of determining the dose to give could help to decide on the best therapy for HES. Objectives: - To determine whether a single-dose of prednisone can be used to predict which people with hypereosinophilia respond to treatment. - To study lack of response to steroid treatment in people with HES. Eligibility: Inclusion criteria: - Individuals with hypereosinophilic syndrome with high eosinophil counts. - Individuals who are willing to have blood drawn before and after getting steroids. Exclusion criteria: - Individuals who are on more than 10mg of prednisone (or similar drug) - Individuals with hypereosinophilic syndrome who are on other medications that could interfere with the study - Women who are pregnant or breast-feeding - Individuals who have a known gene mutation associated with chronic eosinophilic leukemia - Children less than 18 years old who weigh less than 48kg or 106lb Design: - Participants will have a screening visit with a physical exam and medical history. Blood and urine samples will be collected. - Participants will have a single dose of the steroid prednisone by mouth in the morning. Blood samples will be collected 2, 4, 24 hours after this dose. - On the day after the steroid dose, participants will provide another blood sample in the morning. - Participants will start to take prednisone daily when they return home. Blood samples will be collected weekly at the participant s doctor s office. The dose of prednisone will be lowered depending on the weekly eosinophil count. We will try to get each person on the lowest dose of prednisone possible that will control the disorder. Participants who do not respond or have severe side effects will be taken off prednisone. Other treatments will be considered for people who do not respond to steroids. The goal is to evaluate the response to prednisone. Our research will try to figure out why some people do not respond to steroids. Most people will complete the study within 6 to 16 weeks, depending on their response to prednisone.

NCT ID: NCT01511289 Completed - Leukemia Clinical Trials

Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients

Start date: August 2011
Phase: Phase 3
Study type: Interventional

In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

NCT ID: NCT01445561 Completed - Clinical trials for Hematologic Diseases

Ultra Low Dose Interleukin-2 in Healthy Volunteers

Start date: September 28, 2011
Phase: Phase 1
Study type: Interventional

Background: - Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High dose interleukin-2 has been used to treat different types of cancer and immune system disorders. However, it can cause frequent and often serious side effects at the doses currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose) was previously tested in cancer patients and stem cell transplant recipients. The study observed important immune changes and minimal side effects in those patients. Researchers want to test the healthy immune system's responses to very low doses of interleukin-2 to better understand how the drug works. Objectives: - To study the effects of very low doses of interleukin-2 on healthy volunteers. Eligibility: - Healthy volunteers at least 18 years of age. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine samples. - Participants will receive one of two possible very low doses of interleukin-2 every day for 5 days. - Blood samples will be taken twice before the first dose, 1 day after the first dose, and before the next three doses. Followup blood samples will be taken on Days 7, 14, and 28 after the first dose.

NCT ID: NCT01426295 Completed - Hematologic Disease Clinical Trials

Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

Caphosol
Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

NCT ID: NCT01344681 Completed - Febrile Neutropenia Clinical Trials

Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials. Therefore, this study was planned for review of the safety and efficacy in korean patients.