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Study to Evaluate the Reinduction and Second Stop of TKI with Ponatinib in CML in Molecular Response (ResToP)

NCT04160546 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-31

No results posted yet for this study

Summary

The purpose of the present study is to determine the rate of successful treatment-free remission (TFR) within the first 52 weeks following cessation of ponatinib treatment in patients who achieved MR4. Eligible patients had been previously treated with TKI and when patients achieved an optimal molecular response, TKI treatment was discontinued. After loss of response, patients were treated again with a TKI treatment and have documented MR4 for one year at the time of switch to ponatinib to study entry. MR4 is defined as BCR-ABL transcript level ≤ 0.01% IS or undetectable BCR-ABL levels with sample sensitivity of at least 4 log.

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DRUG

Ponatinib 15 MG

Patients will receive ponatinib 15 mg/day for 104 weeks orally. Ponatinib will be self-administered by the patient on a daily schedule. Acetyl salicylic acid (ASA) (100 mg) will be used such auxiliary medicinal product in order to prevent vascular occlusive events related with ponatinib.

DRUG

Acetylsalicylic acid 100 MG

Patients will receive acetylsalicylic acid 100 mg/day for 104 weeks orally.

Sponsors & Collaborators

  • Incyte Biosciences UK

    collaborator INDUSTRY

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Fundacion CRIS de Investigación para Vencer el Cáncer

    lead OTHER

Principal Investigators

  • Joaquín Martínez López, MD · Hospital Universitario 12 de Octubre

  • Valentín García Gutierrez, MD · Hospital Universitario Ramon y Cajal

  • Juan Carlos Hernández Boluda, MD · Hospital Clínico de Valencia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT04160546 on ClinicalTrials.gov