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Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Reinduction and second stop of TKI with Ponatinib in CML in Molecular Response (ResToP)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508993-27-00
Acronym
FCR173011/ResToP
Enrollment
80
Registered
2023-12-21
Start date
2020-01-17
Completion date
2026-01-12
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myelogenous leukemia

Brief summary

Proportion of patients with a maintained MMR within 52 weeks following ponatinib TFR.

Detailed description

- Incidence of treatment-emergent adverse events (new or worsening from baseline)., - Incidence of thromboembolic and hemorrhagic events, hematologic events and gastrointestinal events., - Proportion of patients still in MR4 within 52 weeks following ponatinib TFR., - Proportion of patients who still have a MMR within 24 weeks following ponatinib TFR., - Progression free survival (PFS), - Treatment-free survival (TFS)

Interventions

DRUGIclusig 15 mg film-coated tablets

Sponsors

Fundacion Cris De Investigacion Para Vencer El Cancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients with a maintained MMR within 52 weeks following ponatinib TFR.—

Secondary

MeasureTime frame
- Incidence of treatment-emergent adverse events (new or worsening from baseline)., - Incidence of thromboembolic and hemorrhagic events, hematologic events and gastrointestinal events., - Proportion of patients still in MR4 within 52 weeks following ponatinib TFR., - Proportion of patients who still have a MMR within 24 weeks following ponatinib TFR., - Progression free survival (PFS), - Treatment-free survival (TFS)—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026