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Study in Patients With Chronic Leukemia

NCT03807479 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-09-14

No results posted yet for this study

Summary

This study will include patients suffering from chronic myeloid leukemia (CP-CML), who were treated with tyrosine kinase inhibitor (TKI, a substance that blocks the action of enzymes) in a previous therapy but which has not been effective. Patients will be treated with Ponatinib 30 mg in in this study. The aim of the study is to evaluate the safety and efficacy of Ponatinib as a second line treatment in patients failing or not tolerating first line therapy with any other approved TKIs. It is expected that Ponatinib, due to its efficacy, may be more effective as second line therapy than other approved TKIs and lead to improved overall survival. The effect will be determined by the molecular response rate (MMR) as the primary objective after 12 months of treatment. The safety of the drug will be evaluated on the basis if routine medical and laboratory examinations.

Conditions

  • Leukemia, Myeloid, Chronic-Phase

Interventions

DRUG

Ponatinib

2 film-coated tablets à 15mg for oral administration on a daily basis

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    collaborator INDUSTRY

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Philipp le Coutre, Prof. · Charité Berlin - Department of Hematology, Oncology and Tumor Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2023-02-28
Completion
2023-08-31

Countries

  • Germany

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 NCT03807479 on ClinicalTrials.gov