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

NCT01872442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-02-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Lydia ROY, MD · Poitiers University Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-15
Primary Completion
2018-10-31
Completion
2018-10-31

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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 NCT01872442 on ClinicalTrials.gov