A study of safety and effect of adding a low dose of interferon to dasatinib in patients with newly diagnosed chronic myeloid leukemia (CML)

Phase 1

• Conditions: Chronic Myeloid Leukemia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005989-38-SE
• Lead Sponsor: orwegian University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-27
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified