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ACTIVE NOT RECRUITING Phase 2

Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

NCT01627041 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.

Interventions

  • DRUG Decitabine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Cytarabine
  • DRUG Daunorubicin Hydrochloride
  • OTHER Pharmacological Study

Study Locations (9)

New York

  • Roswell Park Cancer Institute — Buffalo
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York
  • Memorial Sloan Kettering Cancer Center — New York
  • NYP/Weill Cornell Medical Center — New York
  • Montefiore Medical Center-Weiler Hospital — The Bronx
  • Montefiore Medical Center - Moses Campus — The Bronx

Ohio

  • Case Western Reserve University — Cleveland
  • Ohio State University Comprehensive Cancer Center — Columbus

Maine

  • Lafayette Family Cancer Center-EMMC — Brewer

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2011-09-16
Est. Completion 2027-02-01
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 NCT01627041

The ClinicalTrials.gov registry entry for NCT01627041 describes a study currently listed as active not recruiting. 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 178 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 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Decitabine 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: NCT01627041 reports 9 study locations spanning 3 distinct geographic areas — top geographies include New York, Ohio, Maine. 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 NCT01627041 about?

NCT01627041 is a clinical study titled "Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia". This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to ...

What is the current status of trial NCT01627041?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2011-09-16. Estimated completion is 2027-02-01.

What conditions does trial NCT01627041 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Adult Acute Basophilic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic 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 NCT01627041?

The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG), Pharmacological Study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01627041?

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 NCT01627041 being conducted?

This trial has 9 study locations across Maine, New York, Ohio. 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