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Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
NCT00416598 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
Conditions Studied
Interventions
- DRUG Busulfan
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- PROCEDURE Autologous Bone Marrow Transplantation
Study Locations (20)
Massachusetts
- Massachusetts General Hospital Cancer Center — Boston
- Brigham and Women's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
- Commonwealth Hematology Oncology PC-Worcester — Worcester
Illinois
- University of Illinois — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
- NorthShore University HealthSystem-Evanston Hospital — Evanston
Maryland
- University of Maryland/Greenebaum Cancer Center — Baltimore
- Walter Reed National Military Medical Center — Bethesda
- Union Hospital of Cecil County — Elkton
Delaware
- Beebe Medical Center — Lewes
- Christiana Care Health System-Christiana Hospital — Newark
Missouri
- Veterans Administration — Columbia
- University of Missouri - Ellis Fischel — Columbia
California
- UCSF Medical Center-Mount Zion — San Francisco
Florida
- Florida Hospital Orlando — Orlando
Georgia
- Blood and Marrow Transplant Group of Georgia — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2006-11-15 |
| Est. Completion | 2016-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00416598
The ClinicalTrials.gov registry entry for NCT00416598 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Busulfan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00416598 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Massachusetts, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00416598 about?
NCT00416598 is a clinical study titled "Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia". This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decita...
What is the current status of trial NCT00416598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 546 participants. The study started on 2006-11-15. Estimated completion is 2016-12-01.
What conditions does trial NCT00416598 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00416598?
The interventions under investigation include: Busulfan (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Autologous Bone Marrow Transplantation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00416598?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00416598 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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