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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: Active Phase 3 study of Acute Myeloid Leukemia and Myeloid Neoplasm, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,645 participants |
| Start Date | 2011-06-20 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What the registry record for NCT01371981 still lists
NCT01371981 is an interventional study that assigns participants to a tested intervention. Its 1,645 participants enrollment target places it among the larger protocols in the corpus, above the 110-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (1395% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01371981's enrollment target sits among peer trials
1,645 3rd of 306 higher than 304 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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