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