Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01165996
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2010-07-14
Brief Title:
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Proof of Concept Study of Non-DNA Damaging DNMT1 Depletion Therapy for Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00135 | OTHER | None | None |
| CASE2908 | OTHER | Case Comprehensive Cancer Center | None |