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Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response

NCT01850004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-11-03

Study results available
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Summary

The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

Conditions

  • Chronic Phase Chronic Myeloid Leukemia

Interventions

DRUG

Dasatinib

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Molecular MD

    collaborator UNKNOWN

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • MultiPharma

    collaborator UNKNOWN

  • Steering Committee

    collaborator UNKNOWN

  • Bristol-Myers Squibb

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-22
Primary Completion
2017-09-20
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain

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 NCT01850004 on ClinicalTrials.gov