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Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

NCT03573596 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2018-06-29

No results posted yet for this study

Summary

This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.

Conditions

  • CML, Relapsed

Interventions

DRUG

Dasatinib

CML patients who have failed a first stopping attempt and have used any TKI for one year will switch to dasatinib 100 mg qd for an additional 2 years before second stop attempt.

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Henri Mondor University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Aarhus University Hospital

    collaborator OTHER

  • University Hospital, Bonn

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Ulla Olsson-Strömberg, MD PhD · Department of Hematology, Uppsala University Hospital, Uppsala, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2023-02-01
Completion
2024-02-01

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT03573596 on ClinicalTrials.gov