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 ]
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