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Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid Leukemia

NCT04709731 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-03

No results posted yet for this study

Summary

This study will address the therapeutic activity and the safety/biological profile of Ponatinib when used as third line therapy of Chronic Myeloid Leukemia in Chronic Phase after the only two TKIs known for their cardiovascular safety, i.e. Imatinib and Bosutinib.

Conditions

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

Ponatinib 15mg QD

Ponatinib 15 mg tablet, taken orally once daily

DRUG

Ponatinib 30mg QD

Ponatinib 30 mg tablet, taken orally once daily

Sponsors & Collaborators

  • Associazione Italiana Pazienti Leucemia Mieloide Cronica

    lead OTHER

Principal Investigators

  • Carlo Gambacorti · Ospedale San Gerardo - Monza (MI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-10-31
Completion
2025-04-01

Countries

  • Italy

Study Locations

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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 NCT04709731 on ClinicalTrials.gov