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Trial record 10 of 144 for:    "Acute promyelocytic leukemia"

French Registry of First-line Treatment of Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT02938858
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies

Tracking Information
First Submitted Date September 22, 2016
First Posted Date October 19, 2016
Last Update Posted Date October 19, 2016
Study Start Date October 2015
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2016)
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 Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 17, 2016)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title French Registry of First-line Treatment of Acute Promyelocytic Leukemia
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 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
Study Type Observational [Patient Registry]
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count < 10000/μl) aged ≤ 70 years.
Condition Acute Promyelocytic Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • ATRA-chimio
    according to usual practice center
  • ATRA-ATO
    according to usual practice center
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 17, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα.
  • Non-high-risk APL (White Blood Count < 10000/μl at presentation)
  • Age ≤ 70 years

Exclusion Criteria:

  • Relapsed APL
  • Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
  • Age > 70 years
Sex/Gender
Sexes Eligible for Study: All
Ages up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pierre FENAUX, MD +33 1 71 20 70 18 pierre.fenaux@aphp.fr
Contact: Ramy RAHME, MD + 33 1 71 20 70 22 ramy.rahme@gmail.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02938858
Other Study ID Numbers French registry APL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Groupe Francophone des Myelodysplasies
Study Sponsor Groupe Francophone des Myelodysplasies
Collaborators Teva Pharmaceuticals USA
Investigators
Principal Investigator: Pierre FENAUX, MD French APL Cooperative Group
PRS Account Groupe Francophone des Myelodysplasies
Verification Date October 2016