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NCT01660906 · ClinicalTrials.gov registry record · Phase 4

Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

A Phase 4 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 4
Development phase
39
Enrollment target
20
Study locations

NCT01660906: Completed Phase 4 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.

NCT01660906 is a Phase 4 study of Chronic Phase Chronic Myeloid Leukemia that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01660906, a Phase 4 study of Chronic Phase Chronic Myeloid Leukemia, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 4
Development phase
39 participants
Enrollment target
20
Study locations

Study Summary

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Primary Outcome

Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or wors

Conditions Studied

Chronic Phase Chronic Myeloid Leukemia

Interventions

  • DRUG Dasatinib

Study Locations (20)

Other

  • Local Institution - Créteil
  • Local Institution - Lille
  • Local Institution - Pierre-Bénite
  • Local Institution - Pringy
  • Local Institution - Vandœuvre-lès-Nancy
  • Local Institution - Cologne
  • Local Institution - Jena
  • Local Institution - Lübeck
  • Local Institution - Mannheim
  • Local Institution - Rostock
  • Local Institution - Catania
  • Local Institution - Florence
  • Local Institution - Naples
  • Local Institution - Roma
  • Local Institution - Roma

California

  • Pacific Cancer Medical Center - Anaheim

Connecticut

  • Cancer Center Of Central Connecticut - Southington

Maryland

  • St. Agnes Healthcare, Inc. - Baltimore

Ohio

  • Promedica Hematology & Oncology Assoicates - Sylvania

Texas

  • The University Of Texas Md Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2012-12
Est. Completion 2015-10
Phase Phase 4
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01660906 record still lists

NCT01660906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

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

NCT01660906 names 20 study sites across 6 states, led by Other, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01660906 about?

NCT01660906 is a clinical study titled "Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib". This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

What is the current status of trial NCT01660906?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2012-12. Estimated completion is 2015-10.

What conditions does trial NCT01660906 study?

This clinical trial studies the following conditions: Chronic Phase Chronic Myeloid Leukemia.

What interventions are being tested in trial NCT01660906?

The interventions under investigation include: Dasatinib (DRUG).

Who is sponsoring clinical trial NCT01660906?

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

Where is trial NCT01660906 being conducted?

This trial has 20 study locations across California, Connecticut, Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Phase Chronic 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 NCT01660906's enrollment target sits among peer trials

39 1468th of 2000 higher than 526 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Related registry views

Source: ClinicalTrials.gov NCT01660906, the US trial registry maintained by the National Library of Medicine. NCT01660906 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.