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

Study acronym: ResToP
StatusCompleted
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 34 participants (planned 80)
    • Primary and study completion dates changed from estimate of Dec 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised at 1 of 13 sites
  2. Site details revised at 3 of 13 sitesv14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary and study completion dates: Dec 2, 2024 to Dec 2025v12
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 13 of 13 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site contacts updated at 2 of 13 sitesv10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 12 to 13v8
  4. Study sites: 10 to 12v7
  5. Primary and study completion dates: Dec 2, 2023 to Dec 2, 2024v6
  6. Secondary endpoints: 10 to 9
    • Site details revised at 2 of 10 sites
    v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2020 to Jan 17, 2020
    • Site details revised at 10 of 10 sites
    v4
  8. Start date: Dec 2, 2019 to Feb 1, 2020v3
  9. Interventions: Ponatinib plus ASA (Drug) to Acetylsalicylic acid 100 MG (Drug), Ponatinib 15 MG (Drug)
    • Study title shortened, about 7 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04160546
Lead Sponsor Fundacion CRIS de Investigación para Vencer el Cáncer
Collaborators: Incyte Biosciences UK, Apices Soluciones S.L.
Conditions
(from sponsor)		 Chronic Myeloid Leukemia, Chronic Phase
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov