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Leukemia, Myeloid clinical trials

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NCT ID: NCT02890784 Completed - Clinical trials for Myeloid Leukemia, Chronic

Dasatinib Holiday for Improved Tolerability

DasaHIT
Start date: August 2016
Phase: Phase 3
Study type: Interventional

Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability))

NCT ID: NCT02890758 Completed - Clinical trials for Acute Myeloid Leukemia

Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803

Start date: May 22, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the number of natural killer (NK) cells from non-HLA matched donors that can be safely infused into patients with cancer. NK cells are a form of lymphocytes that defend against cancer cells. NK cells in cancer patients do not work well to fight cancer. In this study, the NK cells are being donated by healthy individuals without cancer who are not "matched" by human leukocyte antigen (HLA) genes to patients. After receiving these NK cells, patients may also be given a drug called ALT803. ALT803 is a protein that keeps NK cells alive, helps them grow in number and supports their cancer-fighting characteristics. HLA-unmatched NK cell infusion is investigational (experimental) because the process has not approved by the Food and Drug Administration (FDA).

NCT ID: NCT02888964 Completed - Clinical trials for Leukemia, Myeloid, Chronic-Phase

Pioglityazone and Imatinib for CML Patients

ACTIM
Start date: December 2009
Phase: Phase 2
Study type: Interventional

This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib. Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients. Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML. Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.

NCT ID: NCT02875743 Completed - Clinical trials for Myelodysplastic Syndromes

King's Invasive Aspergillosis Study II

Start date: December 7, 2016
Phase: Phase 4
Study type: Interventional

Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation. This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.

NCT ID: NCT02873338 Completed - Clinical trials for Acute Myeloid Leukemia

Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

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

This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.

NCT ID: NCT02870777 Completed - Clinical trials for Acute Myeloid Leukemia

MRD-directed Therapy for Low-risk and Intermediate-risk AML.

Start date: August 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

NCT ID: NCT02860793 Completed - Clinical trials for Acute Myeloid Leukemia

Role of PTK-7 in Acute Myeloid Leukemias

LAM-PTK7
Start date: January 2014
Phase: N/A
Study type: Interventional

The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at: - evaluating the impact of PTK7 expression on primary AML cells ex vivo - evaluating the diagnostic and prognostic value of a soluble form of PTK7

NCT ID: NCT02856204 Completed - Clinical trials for Acute Myeloid Leukemia

Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia

Start date: August 2016
Phase:
Study type: Observational

This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.

NCT ID: NCT02845297 Completed - Clinical trials for Acute Myeloid Leukemia

Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients

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

This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase) of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule of AZA selected for this study is FDA approved for patients with MDS/AML.

NCT ID: NCT02845232 Completed - Clinical trials for Acute Myeloid Leukemia

Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

Start date: March 2013
Phase: N/A
Study type: Observational

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML. The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.