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Leukemia clinical trials

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NCT ID: NCT01455272 Completed - Leukemia Clinical Trials

New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation

Start date: July 2009
Phase: N/A
Study type: Interventional

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia. It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT. The study hypothesis: Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can - reduce relapse rate - improve survival

NCT ID: NCT01455051 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation

Start date: October 2011
Phase: Phase 2
Study type: Interventional

A good proportion of patients with chronic lymphocytic leukemia (CLL) can be managed effectively with palliative chemotherapy. However, there is a group of younger patients with poor risk disease whose life expectancy is significantly reduced. As a result, reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) has been investigated as a potentially curative procedure. Recently, the European Group for Blood and Marrow Transplantation (EBMT) published a set of guidelines suggesting situations where allo-HCT might be considered a therapeutic option for CLL patients. Their conclusions were that allo-HCT was reasonable for younger CLL patients refractory to fludarabine, relapsing within two years of intensive treatment, or with p53 abnormalities requiring treatment. However, the results with RIC allo-HCT are not entirely satisfactory, and progression-free survival after allo-HCT revolves around 35-40% at 3-5 years following allo-HCT. This is due to non-relapse mortality, which is significantly associated with the development of graft-versus-host disease (GVHD), but also due to disease relapse. These relapses may occur early in the course of the transplantation, like any other hematological malignancy, but late relapses have also been reported. Several strategies have been tested in order to improve these results. The anti-CD20 monoclonal antibody rituximab, given concomitantly with allo-HCT or donor lymphocyte infusions, may reduce graft-versus-host disease and facilitate disease control. This may be due, not only to direct cytotoxicity, but also to modulation of GVHD and the graft-versus CLL effect (GVCLL). Interestingly, rituximab has been shown to promote the cross-presentation of tumor-derived peptides by antigen-presenting cells, thus enhancing the formation of cytotoxic T-cell clones and a GVCLL effect. With the addition of rituximab to the conditioning regimen, rates at 4 years for current progression-free survival (CPFS) and overall survival were 44% and 48%. The investigators hypothesize that ofatumumab, having a more potent anti-CLL activity and complement-dependent cytoxicity than rituximab, could improve disease control and modulate the GVCLL effect more effectively, thus reducing the GVHD rate and subsequently improving the non-relapse mortality and progression-free survival in the long term.

NCT ID: NCT01453062 Completed - Clinical trials for Leukaemia, Lymphocytic, Chronic

Phase IV Observational Study in Chronic Lymphocytic Leukemia

Start date: September 2011
Phase: N/A
Study type: Observational

B-cell chronic lymphocytic leukemia (CLL) is a subtype of mature peripheral B-cell neoplasms, characterized by the accumulation of circulating malignant lymphocytes that typically express cell surface markers CD5, CD20, and CD23. It is the most common type of leukemia in adults in Western Europe and in the US. The median age at diagnosis is 65-70 years, with a male to female ratio of 2:1. Initially, most patients present with asymptomatic lymphocytosis and do not need cytoreductive therapy. Patients with active disease are characterized by a lymphocyte doubling time of less than 6 months, or progressive, even massive lymphadenopathy, hepatosplenomegaly, anemia and thrombocytopenia. Constitutional symptoms such as fever, night sweats, unintended weight loss, and extreme fatigue are common in advanced disease and can significantly impact quality of life. CLL also causes relative immunosuppression that increases the risk of infections that are ultimately the major cause of death in this patient population. Median survival at diagnosis ranges from 5 to 20+ years depending on risk factors, but is only 6 to 14 months for patients with CLL refractory to available therapies. Arzerra (ofatumumab) is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumors. Arzerra is designated as an orphan medicinal product in the European Union (EU) for treatment of chronic lymphocytic leukemia. The Committee for Orphan Medicinal Products (COMP) concluded that chronic lymphocytic leukemia was estimated to be affecting approximately 3.5 in 10,000 persons in the Community at the time the application was made (June 2008) and that the condition is chronically debilitating and life-threatening, in particular due to poor long-term survival in high-risk patients. Arzerra was given a conditional approval in the EU on April 19, 2010. The approved indication in the EU for the product is treatment of CLL in patients refractory to fludarabine and alemtuzumab. A specific obligation for this conditional approval was an agreement by GSK to conduct a post-marketing observational study in CLL patients receiving Arzerra. The data from this study is intended to enhance the evidence of the safety and efficacy of Arzerra as it is used in clinical practice, and once final data are available, together with results of a second specific obligation study, will support the transition from conditional to a full approval of Arzerra in the EU. The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of Arzerra for CLL patients treated in clinical practice. Particular data of interest are: co-morbidities (specific chronic disease diagnoses), concomitant medications, disease (CLL) characteristics, prior treatment regimens, adverse events, reasons for discontinuation of Arzerra therapy, Arzerra response, progression free survival, and overall survival. This is an observational, non-interventional, medical record review study in CLL patients. A total of 100 patients with CLL who have previously received Arzerra, whether alive or deceased, and have either completed the full course of Arzerra therapy or discontinued treatment early will be eligible to participate in the study. Centers across Europe who are members and non members of the European Research Initiative of CLL (ERIC) and treat CLL patients will participate in the study. CLL patients newly initiating Arzerra who are still undergoing the treatment phase and patients having been treated with Arzerra in phase II or phase III clinical trials will be excluded. For patients who have completed approximately 1 year or more of follow up since Arzerra initiation, data on response to Arzerra, adverse events during treatment and subsequent to treatment, patient status, progression free survival and overall survival covering the period up to approximately one-year post-drug initiation will be collected. For patients who have not completed approximately l year of follow-up since Arzerra initiation, including those who have been lost to follow up or died prior to one year or have not yet had a full year to elapse in calendar time, similar data will be collected at the point in time at the last available patient contact with the physician using information in the record. After approach for informed consent from the patient or next of kin for patients who have died to review the medical record, no interaction with the patient will occur.

NCT ID: NCT01452646 Completed - Clinical trials for Acute Myeloid Leukemia

Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia

AML1310
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive results in terms of overall survival at 24 months.

NCT ID: NCT01446081 Completed - Clinical trials for Acute Myeloid Leukemia

An Exercise Trial for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

Start date: June 2011
Phase: Phase 2
Study type: Interventional

Reduced quality of life, fatigue, and loss of physical function are common in patients getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot study showing that exercise during active chemotherapy for AML is feasible, safe, and may improve symptoms and physical function. The investigators now propose to compare our hospital-based supervised exercise program to usual care to see if exercise can improve symptoms, physical function, and improve treatment tolerability.

NCT ID: NCT01445080 Completed - Clinical trials for Recurrent Childhood Acute Lymphoblastic Leukemia

Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

Start date: May 30, 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

NCT ID: NCT01444742 Completed - Leukemia Clinical Trials

Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)

Start date: November 16, 2011
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.

NCT ID: NCT01444716 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia

Start date: December 15, 2011
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.

NCT ID: NCT01441882 Completed - Clinical trials for Refractory Chronic Lymphocytic Leukemia

Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well dasatinib works in treating patients with chronic lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT01440920 Completed - Clinical trials for Acute Myeloid Leukemia

A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

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

The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.