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NCT00538876 · ClinicalTrials.gov registry record · Phase 1
Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00538876 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 30 participants.
The verdict
NCT00538876, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. Secondary Objectives: 1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. 2. To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions. 3. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.
Interventions
- DRUG decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00538876
The ClinicalTrials.gov registry entry for NCT00538876 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which decitabine is the first listed.
NCT00538876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00538876 about?
NCT00538876 is a clinical study titled "Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML". This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropri...
What is the current status of trial NCT00538876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-07. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00538876?
The interventions under investigation include: decitabine (DRUG).
Who is sponsoring clinical trial NCT00538876?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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