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Preleukemia clinical trials

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NCT ID: NCT02550535 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

A Phase I/II Study of Gene-modified WT1 TCR Therapy in MDS & AML Patients

Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II trial to determine safety, clinical efficacy and feasibility of a gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). Patient's white blood cells (T cells) will be modified by transferring a gene which enables them to make a new T cell receptor (TCR) that can recognize fragments of a protein called WT1 (Wilms' tumour 1) which is present at abnormally high levels on the surface of myelodysplastic and leukaemic cells. In this trial, approximately 25 participants with an Human Leukocyte Antigen A2 (HLA-A*0201) tissue type who have failed to achieve or maintain an IWG defined response following hypomethylating agent therapy will be recruited.

NCT ID: NCT02543879 Completed - Clinical trials for Acute Myeloid Leukemia

Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies

Start date: September 2015
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has been established for a treatment cohort, up to 20 additional patients may be enrolled in up to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at the recommended dose for future studies to confirm safety.

NCT ID: NCT02508870 Completed - Clinical trials for Myelodysplastic Syndromes

A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes

Start date: September 30, 2015
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, Phase 1b study of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] monoclonal antibody) in participants who have hypomethylating agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine the safety and tolerability of atezolizumab therapy in these participant populations, including treatment in combination with azacitidine.

NCT ID: NCT02492737 Completed - Clinical trials for Myelodysplastic Syndrome

Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

Start date: August 7, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation

NCT ID: NCT02485535 Completed - Clinical trials for Acute Myeloid Leukemia

Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant

Start date: September 4, 2015
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of selinexor when given after stem cell transplant in treating patients with acute myeloid leukemia that is at intermediate or high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.

NCT ID: NCT02477631 Completed - Clinical trials for Iron Overload Due to Repeated Red Blood Cell Transfusions

Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload status in transfusion dependent, iron-overloaded low risk MDS patients; Primary Objective: • To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen species (ROS). Secondary Objectives: - To evaluate the effect of Deferiprone on other oxidative stress parameters 1. Reduced glutathione 2. Membrane lipid peroxidation 3. External phosphatidylserine - To evaluate the change from baseline to last visit in parameters of iron load. 1. Serum ferritin (despite ongoing RBC transfusions during the study period). 2. LIP 3. LPI 4. serum hepcidin - To evaluate the change from one month preceding baseline visit to last month on study in transfusion requirements. - To monitor safety measures: 1. Adverse events (AEs). 2. Number of discontinuations due to AEs Study design: Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS. All participants will be treated with deferiprone for up to 4 months. Patients will have complete blood count monitored weekly, and will visit the site monthly for assessments of safety and efficacy.

NCT ID: NCT02464657 Completed - Leukemia Clinical Trials

Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of nivolumab that can be give in combination with idarubicin and cytarabine in patients with MDS and AML. The safety and effectiveness of this drug combination will also be studied. This is an investigational study. Nivolumab is not FDA-approved or commercially available. Idarubicin is FDA-approved and commercially available for the treatment of patients with AML. Cytarabine is FDA approved and commercially available for treatment of patient with AML. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.

NCT ID: NCT02462252 Completed - Aplastic Anemia Clinical Trials

Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome

Start date: October 2015
Phase: Phase 2
Study type: Interventional

An open label single arm study to assess efficacy and safety of BL-8040 on top of standard immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and AA over the course of a six month (180 day) treatment period.

NCT ID: NCT02458235 Completed - Clinical trials for Myelodysplastic Syndrome

Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation

Start date: June 2, 2015
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT).

NCT ID: NCT02452346 Completed - Clinical trials for Myelodysplastic Syndrome

Study of Clinical Efficacy and Safety of Tosedostat in MDS

IST-CTI-MDS
Start date: March 20, 2015
Phase: Phase 2
Study type: Interventional

Study WCMC IST-CTI-MDS evaluates the safety and tolerability of tosedostat in adult patients with pathologically confirmed MDS (< 20% blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO) classification after failure of hypomethylating agent-based therapy.