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COMPLETED Phase 2

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

NCT01420926 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 165 participants
Start Date 2011-11-16
Est. Completion 2021-04-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01420926

The ClinicalTrials.gov registry entry for NCT01420926 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 165 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 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. 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: NCT01420926 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Michigan, Massachusetts, Delaware. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01420926?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial