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Clinical Trials/EUCTR2011-005989-38-SE
EUCTR2011-005989-38-SE
Active, not recruiting
Phase 1

A SAFETY AND EFFICACY STUDY OF ADDING LOW DOSE PEGYLATED IFN-ALPHA 2B TO STANDARD DOSE DASATINIB IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC MYELOID LEUKEMIA - Nord CML 007

orwegian University of Science and Technology0 sites22 target enrollmentAugust 27, 2012
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DrugsSPRYCEL (Dasatinib)Peg Intron

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
orwegian University of Science and Technology
Enrollment
22
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2012
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
orwegian University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • •1\. CML in chronic phase under TKI treatment in the Nord CML007 study
  • •2\. Treated with TKI for at least three years and in MR4 for at least one year.
  • •3\. Typical BCR/ABL1 transcript (b3a2 and/or b2a2\) must have been confirmed at diagnosis or later during the disease course.
  • •4\. 18 years or older.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •1\. Previous AP/BC at any time in the history of the disease.
  • •2\. Current participation in another clinical study.
  • •3\. Planned allogeneic stem cell transplantation.

Outcomes

Primary Outcomes

Not specified

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