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Leukemia, Myeloid clinical trials

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NCT ID: NCT01490853 Completed - Clinical trials for Chronic Myeloid Leukemia

Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy

Start date: October 2009
Phase:
Study type: Observational

Objectives This is an observational study aimed at updating the overall survival (OS), the progression free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing the clinical and biological features of this selected cohort of patients with persisting CCgR after treatment with IFN. Study design This study is an observational retrospective multicenter study. Assessment and Follow-up Patients' demographic data and retrospective collection of CML cytogenetic and molecular data will be reported in the "Assessment and Follow-up FORM". In this FORM the events related to therapy, disease and survival will also be reported. Duration of the study: The recruitment period is estimated in approximately 2 years.

NCT ID: NCT01488565 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

A Single Arm Pilot Study of Azacitidine in Myelodysplastic Syndromes (MDS) / Acute Myeloid Leukaemia (AML), With Eltrombopag Support for Thrombocytopenia

Aza-E
Start date: December 2010
Phase: Phase 2
Study type: Interventional

Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by anemia,neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet counts). MDS patients with thrombocytopenia who fail standard therapies require regular platelet transfusions which are expensive and inconvenient, and are a risk for further serious bleeding complications. The new treatment of MDS using azacitidine has shown to increase the survival rate of MDS patients including to improve platelet production over time. However,in the early cycles of treatment with azacitidine,the low platelet counts tend to exacerbate before they provide any clinical benefit. Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been able to increase platelet counts in healthy Thrombocytopenia Purpura (ITP), a disease where patients destroy their own platelets very rapidly and thus develop thrombocytopenia. Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved for the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to standard treatment. This study is a single arm pilot study to evaluate the safety and tolerability of Eltrombopag in the treatment of low platelet counts in adult subjects with MDS treated using azacitidine This study also incorporates a correlative laboratory component designed to determined the mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a baseline profile which may predict those most responsive. These studies will incorporate gene methylation and expression, and immunoprofiling.

NCT ID: NCT01484015 Completed - Breast Cancer Clinical Trials

Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia

Start date: February 2011
Phase: Phase 1
Study type: Interventional

This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

NCT ID: NCT01477606 Completed - Clinical trials for Acute Myeloid Leukemia

Protocol in Acute Myeloid Leukemia With FLT3-ITD

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

This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria. The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD. Sample size: 440 patients The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance and follow-up period: Maximum 8 years

NCT ID: NCT01475370 Completed - Clinical trials for Acute Myeloid Leukemia

Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

Start date: January 24, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.

NCT ID: NCT01475110 Completed - Clinical trials for Chronic Myeloid Leukaemia

Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

CML0609
Start date: September 13, 2012
Phase:
Study type: Observational

The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.

NCT ID: NCT01474681 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

Start date: January 9, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.

NCT ID: NCT01471444 Completed - Leukemia Clinical Trials

Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Start date: November 2, 2011
Phase: Phase 3
Study type: Interventional

The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be studied.

NCT ID: NCT01468467 Completed - Clinical trials for Leukemia, Myeloid, Acute

A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)

Start date: April 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant.

NCT ID: NCT01463046 Completed - Clinical trials for Acute Myeloid Leukemia

Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if Panobinostat is safe to give to patients and to determine the best dose to give in combination with standard cytarabine and daunorubicin chemotherapy.