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Leukemia, Myeloid clinical trials

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NCT ID: NCT01806116 Active, not recruiting - Clinical trials for Higher-risk Myelodysplastic Syndrome

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

DFMBHSCT
Start date: September 2009
Phase: Phase 4
Study type: Interventional

Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients,so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.

NCT ID: NCT01804985 Active, not recruiting - Clinical trials for Chronic Myeloid Leukaemia

De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia

DESTINY
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether some patients with excellent responses to chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec), nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the standard dose for 12 months, and then treatment will be stopped completely for a further two years. The trial information will also help to develop a de-escalation and stopping strategy for future newly diagnosed CML patients in the next British national CML study (to be known as SPIRIT3).

NCT ID: NCT01784068 Active, not recruiting - Clinical trials for Chronic Myelogenous Leukemia

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

ENESTfreedom
Start date: March 4, 2013
Phase: Phase 2
Study type: Interventional

The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

NCT ID: NCT01761890 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia

Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib

CML1113
Start date: January 28, 2014
Phase:
Study type: Observational

The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.

NCT ID: NCT01757535 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Acute

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

QUAZAR AML-001
Start date: April 24, 2013
Phase: Phase 3
Study type: Interventional

This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.

NCT ID: NCT01744223 Active, not recruiting - Lymphoma Clinical Trials

Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.

NCT ID: NCT01716364 Active, not recruiting - Multiple Myeloma Clinical Trials

Safety Study of Anti LewisY Chimeric Antigen Receptor in Myeloma, Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: January 2010
Phase: Phase 1
Study type: Interventional

Patients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not cured with conventional therapy and new approaches are needed. For the last 15 years we have investigated the potential of using a patient's own T cells (a type of white blood cell [WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell culture and animal models of AML and MM. Over the last 5 years we have been preparing to treat patients as part of a Phase I (first in human) clinical trial. The trial treatment involves collecting the patient's own WBCs from the blood by a standard well established and safe process called apheresis. The cells are then cultured in a specialized laboratory (under Good Manufacturing Practice conditions, similar to standards under which pharmaceuticals are produced) over 12 days to convert the cells to specialized tumor-attacking T cells. Early in that culture process the cells are exposed to a virus (that is modified so that it cannot infect or replicate outside the special culture conditions) that contains a special gene. Via the virus, this gene inserts into the patient's T cells in culture and gets incorporated into the T cell's genetic machinery. As the T cells replicate, the new gene produces a protein receptor that becomes part of the patient's T cells. This protein receptor on the T cells has the capacity to specifically recognize and bind to a protein on the leukemia or myeloma cells called the "Lewis Y" antigen. After the modified T cells are infused into the patient, they home into the bone marrow (this tracking is monitored by special radiological techniques) where the new protein receptor on the T cell surface can recognize and bind to the cancer cells (which express Lewis Y). Once bound onto the cancer cells, the T cells get activated and subsequently replicate and kill the cancer cells. The novelty of this approach is that the T-cells will only kill cells that have the Lewis Y on their surface - the cancer cells. Moreover, because there are few normal cells in a person's body that carry Lewis Y, this treatment is likely to only have minor side effects. This gene therapy trial is unique and although the primary purpose is to test the safety of this approach, patients will be monitored closely for anti-tumor responses. As the trial progresses, the dose of T cells infused will increase, in the hope that this will result in a better and stronger immune response to the leukemia or myeloma.

NCT ID: NCT01699217 Active, not recruiting - Clinical trials for Chronic Myeloid Leukaemia

Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase

CML0912
Start date: June 21, 2013
Phase:
Study type: Observational

The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML patients treated frontline with NIL. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early CP.

NCT ID: NCT01698905 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

ENESTop
Start date: December 20, 2012
Phase: Phase 2
Study type: Interventional

A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

NCT ID: NCT01686334 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission

WIDEA
Start date: October 2012
Phase: Phase 2
Study type: Interventional

The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease.