Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-06 @ 7:00 PM
Study NCT ID:
NCT02938858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Study Overview
Official Title:
The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
* 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: