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Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

NCT01593254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2023-06-22

Study results available
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Summary

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Conditions

  • Chronic Phase Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib

DRUG

Dasatinib

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Molecular MD

    collaborator UNKNOWN

  • MultiPharma

    collaborator UNKNOWN

  • Q2 Solutions

    collaborator INDUSTRY

  • Donald E. Morisky

    collaborator UNKNOWN

  • MD Anderson Symptom Inventory (MDASI-CML)

    collaborator UNKNOWN

  • OBiS, Inc

    collaborator UNKNOWN

  • Steering Committee

    collaborator UNKNOWN

  • Bristol-Myers Squibb

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-12
Primary Completion
2017-11-08
Completion
2022-04-12

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Hungary
  • Italy
  • Poland
  • South Korea
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593254 on ClinicalTrials.gov