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Preleukemia clinical trials

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NCT ID: NCT01392989 Completed - Anemia Clinical Trials

Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders

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

Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

NCT ID: NCT01390311 Completed - Clinical trials for Myelodysplastic Syndromes

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

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

This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.

NCT ID: NCT01385423 Completed - Clinical trials for Myelodysplastic Syndrome

Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)

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

This is a single center, "modified standard design" dose escalation study designed to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14 when given after haploidentical donor NK cells in patients with relapse or refractory acute myelogenous leukemia (AML).

NCT ID: NCT01384513 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies

Start date: August 4, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare the survival rates of patients with better risk disease undergoing hematopoietic stem cell transplant (HSCT) to the survival rates reported in the medical literature of similar patients undergoing reduced intensity HSCT from matched related donors.

NCT ID: NCT01381809 Completed - Clinical trials for Myelodysplastic Syndromes

An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

NCT ID: NCT01378416 Completed - Leukemia Clinical Trials

Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Start date: April 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

NCT ID: NCT01362985 Completed - Lymphoma Clinical Trials

Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor

Start date: July 2009
Phase: Phase 4
Study type: Observational

Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization [31 July 2009] and 31 July 2014). The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database. The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.

NCT ID: NCT01362140 Completed - MDS Clinical Trials

Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Start date: December 21, 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

NCT ID: NCT01355913 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

Screening and Genetic Monitoring of Patients With Myelodysplastic Syndromes (MDS) Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34+Cells

Start date: October 2008
Phase:
Study type: Observational

In myelodysplastic syndromes (MDS) the knowledge about chromosomal aberrations is important for diagnosis, pathogenesis, prognosis and treatment. Usually, chromosomal anomalies in MDS patients are detected in bone marrow cells by chromosome banding analyses of metaphases. Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization (FISH). The investigators here present a novel method for cytogenetic monitoring of MDS patients from peripheral blood which is representative for the clone size in bone marrow cells. The purpose of this prospective multicenter non-interventional diagnostic study is to detect and to follow chromosomal aberrations from peripheral blood closely, to assess karyotype evolution, to detect rare abnormalities and to correlate the molecular-cytogenetic results with peripheral blood counts, bone marrow morphology and treatment modalities and responses.

NCT ID: NCT01350245 Completed - Lymphoma Clinical Trials

Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.