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

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ClinicalTrials.gov Identifier: NCT02192619
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Study Description
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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.


Condition or disease Intervention/treatment
Newly-diagnosed APL (de Novo or Therapy-related) Relapsed APL Other: observational

Detailed Description:
  • 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
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Actual Study Start Date : July 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
observational Other: observational


Outcome Measures
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Primary Outcome Measures :
  1. epidemiological parameters [ Time Frame: yearly follow up for 5 years ]
  2. diagnostic quality indicators [ Time Frame: yearly follow up for 5 years ]
  3. type of therapy [ Time Frame: yearly follow up for 5 years ]
  4. response, recurrence and time of death and resulting outcomes RFS and OS [ Time Frame: yearly follow up for 5 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a therapeutic intervention according to their disease state are the study population within this registry.
Criteria

Inclusion Criteria:

  • newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis

  • or relapsed APL, within 12 months of diagnosis of relapse

    1. confirmed by the presence of the translocation t(15; 17)
    2. and / or confirmed by the detection of the fusion transcript of PML/RARa

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192619


Contacts
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Contact: Uwe Platzbecker, Prof. Dr. +49 351 458 3192 Uwe.Platzbecker@medizin.uni-leipzig.de
Contact: Michaela Weier +49 351 458 3192 michaela.weier@ukdd.de

Locations
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Germany
Prof. Dr. U. Platzbecker Recruiting
Dresden, Germany, 01307
Contact: Uwe Platzbecker, Prof. Dr.    +49 351 458 3192    Uwe.Platzbecker@medizin.uni-leipzig.de   
Contact: Michaela Weier    +49 351 458 3192    michaela.weier@ukdd.de   
Sponsors and Collaborators
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Investigators
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Principal Investigator: Richard F. Schlenk, Prof. Dr. Universitätsklinikum Ulm, for the AML-SG group
Principal Investigator: Eva Lengfelder, PD Dr. Universitätsklinikum Mannheim
Principal Investigator: Dietger Niederwieser, Prof. Dr. Universitätsklinikum Leipzig
More Information
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Additional Information:

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Responsible Party: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier: NCT02192619    
Other Study ID Numbers: NAPOLEON-Registry
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Keywords provided by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH:
APL
acute promyelocytic leukemia
AML M3
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
 Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid