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NCT00416598 · ClinicalTrials.gov registry record · Phase 2
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 546
- Enrollment target
- 20
- Study locations
NCT00416598: Completed Phase 2 study of Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
NCT00416598 is a Phase 2 study of Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 546 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (379% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00416598, a Phase 2 study of Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 546 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.
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 |
What the finished NCT00416598 record still lists
NCT00416598 is an interventional study that assigns participants to a tested intervention. The registered 546 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (379% higher).
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.
NCT00416598 names 20 study sites across 11 states, led by Massachusetts, Illinois, Maryland.
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.
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).
Who is sponsoring clinical trial NCT00416598?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00416598's enrollment target sits among peer trials
546 7th of 306 higher than 300 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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