MedTrace Logo

Randomized Study Comparing the Effect of Dasatinib and Imatinib on Malignant Stem Cells in Chronic Myeloid Leukemia

NCT00852566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-09-25

No results posted yet for this study

Summary

A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18 months and approximately 40 patients will be recruited to the study.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib

Per oral imatinib 400mg once daily (continuous medication)

DRUG

Dasatinib

Per oral dasatinib 100mg once daily (continuous medication)

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Satu Mustjoki, MD, PhD · Helsinki University Central Hospital, helsinki, Finland

  • Henrik Hjorth-Hansen, MD, PhD · St. Olavs Hospital, Trondheim, Norway

  • Ole Weiss-Bjerrum, MD, PhD · Rigshospitalet, Denmark

  • Ingunn Dybedal, MD, PhD · Rikshospitalet, Oslo, Norway

  • Tobias Gedde-Dahl, MD, PhD · Rikshospitalet, Oslo, Norway

  • Kimmo Porkka, MD, PhD · Helsinki University Central Hospital, Helsinki, Finland

  • Johan Richter, MD, PhD · University of Lund, Lund, Sweden

  • Bengt Simonsson, MD, PhD · University Hospital, Uppsala, Sweden

  • Leif Stenke, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-02-28
Completion
2015-12-31

Countries

  • Finland
  • 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 NCT00852566 on ClinicalTrials.gov