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Leukemia, Myeloid clinical trials

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NCT ID: NCT00511303 Completed - Clinical trials for Chronic Myeloid Leukemia

Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia

Start date: August 2000
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label, multi-center trial designed primarily to evaluate the rate of complete or major cytogenetic response of STI571 as demonstrated by a decrease in the percentage of Ph chromosome positive cells in the bone marrow, in patients with CML who are refractory to or intolerant of interferon-alpha. During the core phase of the study, patients will receive once daily oral administration of STI571 at a dose of 400 mg, for up to 12 months. After completing 12 months of therapy patients may be eligible to receive additional therapy provided that, in the opinion of the investigator, the patient has benefited from treatment with STI571 and in the absence of safety concerns. Patients will receive STI571 on an outpatient basis. During the extended phase (which is of indefinite duration), patients may continue STI571 until either progression to accelerated phase, blast phase, death, the development of intolerable toxicity, or the investigator feels it is no longer in the patient's best interest to continue therapy, whichever comes first. The number of visits will be at a reduced frequency. Patients who discontinue study drug will be followed for survival for up to 5 years. STI571 will be considered active if the interferon-refractory patient population satisfies the target of achieving a complete or major response at a rate of at least 30%, within the preset error limits. Cytogenetic responses will be evaluated every three months and categorized as either complete (0% Ph+ chromosome cells), or major (1 to 35% Ph+ chromosome cells) responses. STI571 will be discontinued for any patient whose disease progresses to either the accelerated phase or blast crisis. A minimum of 100 patients who are interferon refractory will receive STI571 administered at a dose of 400 mg once a day. In addition, the protocol is also open for patients who are intolerant to interferon-alpha in order to get a preliminary evaluation of their response to STI571 therapy. Up to 100 intolerant patients will be enrolled. Enrollment of intolerant patients will cease at 100, or whenever the 100 refractory patients are accrued, whichever comes first.

NCT ID: NCT00510926 Completed - Clinical trials for Myeloid Leukemia, Chronic, Chronic-Phase

Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase

Start date: January 2004
Phase: Phase 2
Study type: Interventional

Results in CP are better in patients treated early after the onset of the disease with respect to late CP . To date, the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk (88 and 84% versus 65%). High dose of imatinib, as shown in phase I-III trials may offer the possibility to increase the response rate of patients belonging to this risk category.

NCT ID: NCT00510133 Completed - Clinical trials for Acute Myelogenous Leukemia

A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.

NCT ID: NCT00509093 Completed - Leukemia Clinical Trials

Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy

Start date: October 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.

NCT ID: NCT00505700 Completed - Leukemia Clinical Trials

VELCADE in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia

Start date: July 2003
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.

NCT ID: NCT00504920 Completed - Leukemia Clinical Trials

Symptom-Related Cytokines in Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Patients

Start date: May 2004
Phase: N/A
Study type: Observational

Primary Objective: 1. To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients pretransplantation and posttransplantation with allogeneic blood and marrow in order to identify changes in symptoms (or symptom clusters) and changes in cytokines that may be related to the conditioning regimen and/or to the development of GVHD during the 100 days posttransplant. Based on the current literature, both animal and human research, in this study we hypothesize that increases in TNF alpha to be associated with poor appetite, sleep disturbance and fatigue, but not with increases in pain, depression and numbness.

NCT ID: NCT00499785 Completed - Depression Clinical Trials

Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Start date: June 2007
Phase: N/A
Study type: Observational

RATIONALE: Learning about physical ability and mental function over time in older patients with acute myeloid leukemia may help doctors learn about the long-term effects of treatment and plan the best treatment. PURPOSE: This clinical trial is assessing physical and mental status in older patients with newly diagnosed acute myeloid leukemia.

NCT ID: NCT00497991 Completed - Myeloid Leukemia Clinical Trials

Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

Start date: May 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.

NCT ID: NCT00493181 Completed - Leukemia Clinical Trials

Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients

Start date: October 2005
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606. Primary Objective: 1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML. Secondary Objective: 1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors

NCT ID: NCT00491634 Completed - Clinical trials for Acute Myeloid Leukemia

Treosulfan-based Conditioning for Transplantation in AML/MDS

Start date: June 2007
Phase: Phase 2
Study type: Interventional

The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan, will reduce toxicity after allogeneic transplantation while improving myeloablation and and disease control in patients with AML and MDS not eligible for standard transplantation.