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NCT01460160 · ClinicalTrials.gov registry record · Phase 2

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

A Phase 2 study of Leukemia, Pediatric, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
106
Enrollment target
20
Study locations

NCT01460160: Completed Phase 2 study of Leukemia, Pediatric, sponsored by Bristol-Myers Squibb.

NCT01460160 is a Phase 2 study of Leukemia, Pediatric that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01460160, a Phase 2 study of Leukemia, Pediatric, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
106 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

Primary Outcome

3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause

Conditions Studied

Interventions

  • DRUG Dasatinib

Study Locations (20)

California

  • Antranik Agop Bedros - Loma Linda
  • Miller Children's and Women Hospital - Long Beach
  • Children'S Hospital Of L.A. - Los Angeles
  • Southern California Permanente Medical Group - Los Angeles
  • Valley Children's Hospital - Madera
  • Children's Hospital of Orange County - Orange
  • Lpch & Sumc - Palo Alto
  • Kaiser Medical Center - Roseville
  • Ucsf - Hematology/Oncology - San Francisco

Florida

  • Lee Memorial Health System - Fort Myers
  • University Of Florida - Gainesville
  • Nemours Children'S Clinic - Jacksonville
  • Md Anderson Cancer Center Orlando - Orlando

Alabama

  • University Of Alabama At Birmingham - Birmingham

Arizona

  • Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. - Phoenix

Arkansas

  • University Of Arkansas For Medical Sciences - Little Rock

Colorado

  • Children'S Hospital Colorado - Aurora

Connecticut

  • Connecticut Children's Medical Center - Hartford

Delaware

  • A. I. Dupont Hospital For Children - Wilmington

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2012-04-13
Est. Completion 2021-06-01
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01460160 record still lists

NCT01460160 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Leukemia, Pediatric appearing as the primary indexed condition, and to 1 intervention - of which Dasatinib is the first listed.

NCT01460160 names 20 study sites across 9 states, led by California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT01460160 about?

NCT01460160 is a clinical study titled "Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia". The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

What is the current status of trial NCT01460160?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2012-04-13. Estimated completion is 2021-06-01.

What conditions does trial NCT01460160 study?

This clinical trial studies the following conditions: Leukemia, Pediatric.

What interventions are being tested in trial NCT01460160?

The interventions under investigation include: Dasatinib (DRUG).

Who is sponsoring clinical trial NCT01460160?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01460160 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01460160's enrollment target sits among peer trials

106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01460160, the US trial registry maintained by the National Library of Medicine. NCT01460160 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.