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Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Chronic Myeloid Leukemia

NCT04043676 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-08-02

No results posted yet for this study

Summary

Ponatinib has shown to induce deeper molecular responses compared with imatinib. Therefore, ponatinib treatment could increase the proportion of patients who could discontinue treatment successfully. This strategy that includes treatment change to a more powerful treatment before treatment discontinuation has not been evaluated in any of the previous clinical trials, and will be explored in the current study.

In this framework, the purpose is to determine the rate of successful treatment-free remission (TFR) within the first 48 weeks following cessation of treatment in patients who achieved Molecular Response 4 (MR4) on imatinib and maintained MR4 on ponatinib after a switch from imatinib. Eligible patients have been previously treated with imatinib as unique tyrosine kinase inhibitor (at least 4 years) and have documented MR4 (at least 12 months) at the time of switch to ponatinib to study entry.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Ponatinib

All patient will take 15 mg/day ponatinib oral during 48 weeks.

Sponsors & Collaborators

  • Fundación Teófilo Hernando, Spain

    lead OTHER

Principal Investigators

  • Juan Luis Steegmann, MD PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Valentin Garcia Gutierrez, MD PhD · Hospital Universitario Ramon y Cajal

  • Rosa Ayala, MD PhD · Hospital Universitario Doce de Octubre

  • Luis Felipe Casado, Dr. · Hospital Universitario Virgen del Rocio

  • Fermin Sanchez-Guijo, MD PhD · University of Salamanca

  • Juan Carlos Hernandez, Dr. · Hospital Clínico Universitario de Valencia

  • Guillermo Orti, Dr. · Hospital Vall d'Hebron

  • Blanca Xicoy, Dr. · Hospital German Trials i Pujol

  • Antonio Jimenez, Dr. · Hospital Regional Universitario de Malaga

  • Maria Teresa Gomez, Dr. · Hospital Universitario de Gran Canarias Dr. Negrin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • Spain

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 NCT04043676 on ClinicalTrials.gov