NCT01872442

Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators address the question of the efficacy and safety of dasatinib in combination with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia in Chronic phase.

Conditions

• Chronic Phase of Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Dasatinib 100mg daily starting at inclusion If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes \> 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study
DRUG	Peg-Interferon alpha2b	30 µg weekly starting month 4- month 21

Timeline

• Start date: 2013-10-15
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2013-06-07
• Last updated: 2020-02-10