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NCT02130557 · ClinicalTrials.gov registry record · Phase 3

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

A Phase 3 study of Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
536
Enrollment target
20
Study locations

NCT02130557: Completed Phase 3 study of Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive, sponsored by Pfizer.

NCT02130557 is a Phase 3 study of Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive that has completed, run by Pfizer. The registered enrollment target is 536 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% 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

NCT02130557, a Phase 3 study of Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
536 participants
Enrollment target
20
Study locations

Study Summary

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Primary Outcome

MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (\<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to \[\>=\] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \[\>=3000 ABL required\]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.

Interventions

  • DRUG Bosutinib
  • DRUG Imatinib

Study Locations (20)

Idaho

  • Saint Alphonsus Regional Medical Center, Cancer Care Center - Boise
  • Saint Alphonsus Regional Medical Center - Boise
  • Saint Alphonsus Caldwell Cancer Care Center - Caldwell
  • Saint Alphonsus Medical Center Nampa - Nampa

Louisiana

  • Cancer Center of Acadiana at Lafayette General Medical Center - Lafayette
  • Lafayette General Medical Center - Lafayette
  • LSU Health Sciences Center-Shreveport - Shreveport
  • University Health Shreveport - Shreveport

Georgia

  • Emory University Hospital - Atlanta
  • The Emory Clinic - Atlanta
  • Winship Cancer Institute, Emory University - Atlanta

Illinois

  • University of Illinois Cancer Center - Chicago
  • John H. Stroger, Jr. Hospital of Cook County - Chicago

Indiana

  • Indiana Blood and Marrow Transplantation - Indianapolis
  • PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D - Indianapolis

Massachusetts

  • University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy - Worcester
  • University of Massachusetts Memorial Medical Center - Worcester

California

  • Pacific Cancer Medical Center, Inc. - Anaheim

Hawaii

  • Kaiser Permanente Hawaii - Honolulu

Trial Details

FieldValue
Enrollment Target 536 participants
Start Date 2014-07-15
Est. Completion 2020-04-17
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT02130557 record still lists

NCT02130557 is an interventional study that assigns participants to a tested intervention. The registered 536 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).

The record links to 1 condition, with Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive appearing as the primary indexed condition, and to 2 interventions - of which Bosutinib is the first listed.

NCT02130557 names 20 study sites across 9 states, led by Idaho, Louisiana, Georgia.

Frequently Asked Questions

What is clinical trial NCT02130557 about?

NCT02130557 is a clinical study titled "A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia". Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

What is the current status of trial NCT02130557?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 536 participants. The study started on 2014-07-15. Estimated completion is 2020-04-17.

What conditions does trial NCT02130557 study?

This clinical trial studies the following conditions: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive.

What interventions are being tested in trial NCT02130557?

The interventions under investigation include: Bosutinib (DRUG), Imatinib (DRUG).

Who is sponsoring clinical trial NCT02130557?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02130557 being conducted?

This trial has 20 study locations across California, Georgia, Hawaii, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02130557's enrollment target sits among peer trials

536 702nd of 2000 higher than 1,299 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02130557, the US trial registry maintained by the National Library of Medicine. NCT02130557 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.