NCT04160546

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fundacion CRIS de Investigación para Vencer el Cáncer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-01-17
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-11-13
• Last updated: 2024-12-31

Locations

13 sites across 1 country: Spain