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Myelodysplastic Syndromes clinical trials

View clinical trials related to Myelodysplastic Syndromes.

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NCT ID: NCT02397720 Completed - Clinical trials for Myelodysplastic Syndrome

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia

Start date: April 7, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and best dose of nivolumab and azacitidine with or without ipilimumab when given together and to see how well they work in treating patients with acute myeloid leukemia that has not responded to previous treatment or has returned after a period of improvement or is newly diagnosed. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as azacitidine, 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. Giving nivolumab, azacitidine and ipilimumab may kill more cancer cells.

NCT ID: NCT02390414 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study

Start date: May 2011
Phase:
Study type: Observational

The purpose of this observational study is to compare overall survival in older adults with myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem cell transplant (RIC HSCT) versus those who do not receive HSCT.

NCT ID: NCT02378701 Completed - Leukemia Clinical Trials

Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease

Start date: February 2015
Phase:
Study type: Observational

The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in patients with MDS. This is an investigational study. Up to 240 participants will be enrolled in this multicenter study. Up to 175 will take part at MD Anderson.

NCT ID: NCT02367456 Completed - Clinical trials for Acute Myeloid Leukemia

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

BRIGHT 1012
Start date: April 28, 2015
Phase: Phase 1
Study type: Interventional

This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

NCT ID: NCT02363491 Completed - Clinical trials for Myelodysplastic Syndrome

A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome

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

The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).

NCT ID: NCT02345850 Completed - Acute Leukemia Clinical Trials

Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)

Start date: August 2015
Phase: Phase 3
Study type: Interventional

The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.

NCT ID: NCT02335268 Completed - Clinical trials for Myelodysplastic Syndromes

Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia

EUROPE
Start date: May 21, 2015
Phase: Phase 2
Study type: Interventional

There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

NCT ID: NCT02333058 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies

Start date: November 21, 2014
Phase: Phase 2
Study type: Interventional

The primary goal of this study is to evaluate an alternative myeloablative, but reduced toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous (i.v.) Treosulfan administered as part of a standardised Fludarabine-containing conditioning and to contribute to the current pharmacokinetic model to be able to finally give age (or body surface area) dependent dose recommendations. The treatment regimens given in the protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data. Considering the vital indication for allogeneic haematopoietic stem cell transplantation of the selected patient population, the risk-benefit assessment is therefore reasonably in favour of the study conduct.

NCT ID: NCT02323139 Completed - MDS Clinical Trials

A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

LDE255
Start date: February 10, 2015
Phase: Phase 1
Study type: Interventional

This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

NCT ID: NCT02308761 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Start date: November 6, 2014
Phase: Phase 1
Study type: Interventional

RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment Period. A standard 3+3 design will be used in which successive cohorts of three or more participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a maximum tolerated dose (MTD) is identiļ¬ed. Up to 51 adult participants with AML or MDS will be enrolled in the study.