Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (379% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
RECRUITING · Phase 2
-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RECRUITING · Phase 2
-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · Phase 2
Explore more on PlainTrial
Acute Myeloid Leukemia
All registered trials for this condition
Untreated Adult Acute Myeloid Leukemia
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.