Clinical Trial: National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup

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

Official Title: National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup

Brief Summary:

The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.

Prospective population-based non-interventional and non-randomized multicenter registry.


Detailed Summary:

  • collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence
  • documentation of efficacy and safety of the first line and salvage therapy in APL including
  • documentation of minimal residual disease (MRD)
  • correlation of clinical outcomes with chosen therapy
  • collection and evaluation of quality of life
  • validation of published prognostic factors / new potential prognostic factors
  • acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and translational studies under the umbrella of the specific study-group biobanking concepts

Sponsor: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Current Primary Outcome:

  • epidemiological parameters [ Time Frame: yearly follow up for 5 years ]
  • diagnostic quality indicators [ Time Frame: yearly follow up for 5 years ]
  • type of therapy [ Time Frame: yearly follow up for 5 years ]
  • response, recurrence and time of death and resulting outcomes RFS and OS [ Time Frame: yearly follow up for 5 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • complete remission (CR) and CRm [ Time Frame: yearly follow up for 5 years ]
  • treatment related mortality (TRM) [ Time Frame: yearly follow up for 5 years ]
  • cumulative incidence of relapse (CIR) [ Time Frame: yearly follow up for 5 years ]
  • grade IV toxicities [ Time Frame: yearly follow up for 5 years ]
  • quality of life (QoL): EORTC QLQ-C30 [ Time Frame: yearly follow up for 5 years ]


Original Secondary Outcome: Same as current

Information By: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Dates:
Date Received: July 11, 2014
Date Started: June 2014
Date Completion: December 2020
Last Updated: May 9, 2017
Last Verified: May 2017