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NCT01371981 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Acute Myeloid Leukemia and Myeloid Neoplasm, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
1,645
Enrollment target
20
Study locations

NCT01371981 is a Phase 3 study of Acute Myeloid Leukemia and Myeloid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,645 participants, above the 110-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (1395% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT01371981, a Phase 3 study of Acute Myeloid Leukemia and Myeloid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,645 participants
Enrollment target
20
Study locations

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)

3,257 total trials

What the Registry Record Tells You About NCT01371981

The ClinicalTrials.gov registry entry for NCT01371981 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,645 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (1395% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT01371981 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

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.

What interventions are being tested in trial NCT01371981?

The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Bortezomib (DRUG), Daunorubicin Hydrochloride (DRUG), Asparaginase (DRUG).

Who is sponsoring clinical trial NCT01371981?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

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

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.