Clinical Trial: French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

Brief Summary: The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

Detailed Summary:

  • Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status…).
  • Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients.
  • Documentation of Minimal Residual Disease (MRD).
  • Correlation of clinical outcomes with the chosen therapy.
  • Validation of published prognostic factors and identification of new prognostic factors

Sponsor: Groupe Francophone des Myelodysplasies

Current Primary Outcome: Event-free survival [ Time Frame: From date of induction until the date of first documented event, assessed up to 60 months ]

events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the consolidation courses; relapse; death including early death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of hematological complete remission [ Time Frame: up to 30 days ]
    from date of inclusion until end of induction therapy
  • Rate of overall survival [ Time Frame: at 5 years ]


Original Secondary Outcome: Same as current

Information By: Groupe Francophone des Myelodysplasies

Dates:
Date Received: September 22, 2016
Date Started: October 2015
Date Completion: October 2022
Last Updated: October 17, 2016
Last Verified: October 2016