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ACTIVE NOT RECRUITING Phase 3

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT01371981 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.

Interventions

  • DRUG Etoposide
  • DRUG Cytarabine
  • DRUG Bortezomib
  • DRUG Daunorubicin Hydrochloride
  • DRUG Asparaginase

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center — Downey
  • City of Hope Comprehensive Cancer Center — Duarte
  • Loma Linda University Medical Center — Loma Linda
  • Miller Children's and Women's Hospital Long Beach — Long Beach
  • Children's Hospital Los Angeles — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • Valley Children's Hospital — Madera
  • UCSF Benioff Children's Hospital Oakland — Oakland
  • Kaiser Permanente-Oakland — Oakland
  • Children's Hospital of Orange County — Orange
  • Lucile Packard Children's Hospital Stanford University — Palo Alto
  • Sutter Medical Center Sacramento — Sacramento

Alabama

  • Children's Hospital of Alabama — Birmingham
  • University of Alabama at Birmingham Cancer Center — Birmingham
  • USA Health Strada Patient Care Center — Mobile

Arizona

  • Banner Children's at Desert — Mesa
  • Phoenix Childrens Hospital — Phoenix
  • Banner University Medical Center - Tucson — Tucson

Arkansas

  • Arkansas Children's Hospital — Little Rock
  • University of Arkansas for Medical Sciences — Little Rock

Trial Details

FieldValue
Enrollment Target 1,645 participants
Start Date 2011-06-20
Est. Completion 2027-09-30
Phase Phase 3

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 NCT01371981

The ClinicalTrials.gov registry entry for NCT01371981 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 1,645 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 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Etoposide 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: NCT01371981 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 NCT01371981 about?

NCT01371981 is a clinical study titled "Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemot...

What is the current status of trial NCT01371981?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,645 participants. The study started on 2011-06-20. Estimated completion is 2027-09-30.

What conditions does trial NCT01371981 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myeloid Neoplasm, Myeloid Sarcoma, Leukemia Cutis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01371981?

The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Bortezomib (DRUG), Daunorubicin Hydrochloride (DRUG), Asparaginase (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01371981?

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 NCT01371981 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. 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