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Hematologic Diseases clinical trials

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NCT ID: NCT01666080 Recruiting - Hemoglobinopathies Clinical Trials

Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

Start date: August 2012
Phase: N/A
Study type: Interventional

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.

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: NCT01579110 Active, not recruiting - Anemia Clinical Trials

Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy,extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

NCT ID: NCT01556828 Terminated - Mycosis Fungoides Clinical Trials

Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

Start date: June 2011
Phase: N/A
Study type: Observational

The goal of this study is to identify genetic changes associated with the initiation, progression, and treatment response of response of cutaneous and hematologic disorders using recently developed high-throughput sequencing technologies. The improved understanding of the genetic changes associated with cutaneous and hematologic disorders may lead to improved diagnostic, prognostic and therapeutic options for these disorders.

NCT ID: NCT01553461 Recruiting - Clinical trials for Hematologic Diseases

Transplants With Unlicensed Preserved Cord Blood

Start date: February 21, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under certain safety standards. However, most available cord blood units were collected before the FDA set these standards. These units may not meet FDA standards, but they do meet similar standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that do not meet the new FDA standards may be used for transplants only as part of a research study. Doctors want to allow people who need transplants to receive cord blood that meets NMDP standards but may not meet FDA standards. Objectives: - To allow selected cord blood units that do not meet current FDA standards to be used for transplant. Eligibility: - Individuals who need cord blood units for transplant, and who best match cord blood units that are not FDA-licensed. Design: - Participants will provide consent to receive cord blood that meets NMDP standards but may not meet FDA standards. - Participants will remain on the study for observation for up to 1 year after transplant, or until they withdraw from the study for personal or medical reasons....

NCT ID: NCT01541631 Not yet recruiting - Anemia Clinical Trials

A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

Start date: May 2012
Phase: N/A
Study type: Interventional

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

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: NCT01518959 Terminated - Clinical trials for Chronic Lymphoid Leukemia

The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

D-HEM
Start date: January 2012
Phase: Phase 3
Study type: Interventional

Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival. In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.

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.