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NCT01420926 · ClinicalTrials.gov registry record · Phase 2
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT01420926: Completed Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
NCT01420926 is a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 165 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420926, a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.
Primary Outcome
Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Bortezomib
- OTHER Pharmacological Study
Study Locations (20)
Michigan
- Bronson Battle Creek - Battle Creek
- Spectrum Health Big Rapids Hospital - Big Rapids
- Cancer Research Consortium of West Michigan NCORP - Grand Rapids
- Mercy Health Saint Mary's - Grand Rapids
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Delaware
- Beebe Medical Center - Lewes
- Christiana Care Health System-Christiana Hospital - Newark
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Maine
- Harold Alfond Center for Cancer Care - Augusta
- Eastern Maine Medical Center - Bangor
California
- Palo Alto Medical Foundation-Camino Division - Mountain View
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2011-11-16 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
What the finished NCT01420926 record still lists
NCT01420926 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (43% higher).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01420926 names 20 study sites across 12 states, led by Michigan, Massachusetts, Delaware.
Frequently Asked Questions
What is clinical trial NCT01420926 about?
NCT01420926 is a clinical study titled "Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia". This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stoppin...
What is the current status of trial NCT01420926?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2011-11-16. Estimated completion is 2021-04-01.
What conditions does trial NCT01420926 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Therapy-Related Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01420926?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Bortezomib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01420926?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01420926 being conducted?
This trial has 20 study locations across California, Connecticut, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01420926's enrollment target sits among peer trials
165 54th of 306 higher than 252 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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