Myelodysplastic Syndromes Clinical Trial
Official title:
A Proof of Concept Study of Non-DNA Damaging DNMT1 Depletion Therapy for Myelodysplastic Syndrome
RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.
PRIMARY OBJECTIVES:
I. Demonstrate that differentiation therapy with DNMT1 depleting but non-DNA damaging doses
of decitabine is efficacious and can be administered weekly for > = 12 months. SECONDARY
OBJECTIVES: I. Assess safety of the regimen.
II. Retrospectively compare study and standard regimen clinical responses. III. Assess the
ability of a pharmacodynamic assay that measures DNMT1 depletion in peripheral blood white
blood cells to predict clinical responses to decitabine.
IV. Assess PCR for aberrant methylation signature as an early marker of relapse. V. Identify
biologic features of MDS that correlate with response to decitabine, thereby facilitating
future patient selection.
VI. In cases of relapse or resistance, assess the role of the enzyme CDA in altering
decitabine metabolism and preventing DNMT1 depletion.
OUTLINE:
INDUCTION PHASE: Patients receive decitabine subcutaneously (SC) twice weekly for 4 weeks or
thrice weekly until achieving bone marrow blasts < 5%.
MAINTENANCE PHASE: Patients then receive decitabine SC twice weekly for up to 52 weeks in the
absence of disease progression or unacceptable toxicity. After completion of study treatment,
patients are followed periodically.
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