Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant
Summary
Primary:
To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT) performed for AML or high-risk MDS.
Description
Secondary:
- To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.
- To determine the rates disease relapse, 1-year disease-free survival, and overall survival.
- To assess lymphoid and myeloid chimerism while on decitabine maintenance.
- To determine the incidence of acute and chronic GVHD.
- To assess immunologic reconstitution after alloHSCT.
- To assess changes in gene expression and methylation patterns following decitabine treatment
- To assess the effects of decitabine on immune reconstitution post transplant.
- To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after decitabine treatment.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Leukemia, Myeloid, Acute
Intervention
Decitabine 5 mg/m2/day, Decitabine 7.5mg /m2/day, Decitabine 10 mg/m2/day
Location
Washington University School of Medicine
St. Louis
Missouri
United States
63110
Status
Recruiting
Source
Washington University School of Medicine
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00986804
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:18:58-0400
Clinical Trials
Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)
The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic mate...
Trial of Decitabine in Patients With Acute Myeloid Leukemia
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient...
AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of AR-42 when given together with decitabine in treating patients with acute myeloid leukemia. AR-42 may stop the growth of cancer...
Efficacy of Decitabine in Clearance of MRD
In this open-label, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) r...
This pilot clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. Th...
PubMed Articles
Decitabine is widely used in the treatment of acute myeloid leukemia (AML) in elderly patients. Low-dose Vitamin C has also been indicated to induce DNA demethylation at the cellular level. However, l...
Guillain-Barré syndrome (GBS) is an immune-mediated acute disorder of the peripheral nervous system. Despite treatment, there is an associated mortality and severe disability in 9 to 17% of the cases...
Triple-negative breast cancer (TNBC) is a heterogeneous disease with poor prognosis that lacks targeted therapies, especially in patients with chemotherapy-resistant disease. Since DNA methylation-ind...
The current therapy for elderly patients with high-risk myelodysplastic syndromes (MDSs) remains unsatisfactory. Decitabine, which has been approved to treat MDS, cannot eliminate malignant clones of ...
Medical and Biotech [MESH] Definitions
Leukemia, Myelomonocytic, Acute
A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.
Leukemia, Eosinophilic, Acute
A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.
Leukemia, Promyelocytic, Acute
An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.
Leukemia, Biphenotypic, Acute
An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.
Leukemia, Myeloid, Acute
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.
