NCT02192619

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

10.4 years

First QC Date

July 11, 2014

Last Update Submit

February 22, 2024

Conditions

Newly-diagnosed APL (de Novo or Therapy-related)Relapsed APL

Keywords

APLacute promyelocytic leukemiaAML M3

Outcome Measures

Primary Outcomes (4)

  • epidemiological parameters

    yearly follow up for 5 years

  • diagnostic quality indicators

    yearly follow up for 5 years

  • type of therapy

    yearly follow up for 5 years

  • response, recurrence and time of death and resulting outcomes RFS and OS

    yearly follow up for 5 years

Secondary Outcomes (5)

  • complete remission (CR) and CRm

    yearly follow up for 5 years

  • treatment related mortality (TRM)

    yearly follow up for 5 years

  • cumulative incidence of relapse (CIR)

    yearly follow up for 5 years

  • grade IV toxicities

    yearly follow up for 5 years

  • quality of life (QoL): EORTC QLQ-C30

    yearly follow up for 5 years

Study Arms (1)

observational

Other: observational

Interventions

observationalOTHER
observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis
  • or relapsed APL, within 12 months of diagnosis of relapse
  • confirmed by the presence of the translocation t(15; 17)
  • and / or confirmed by the detection of the fusion transcript of PML/RARa

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. U. Platzbecker

Dresden, 01307, Germany

RECRUITING

Related Publications (1)

  • Kayser S, Schlenk RF, Lebon D, Carre M, Gotze KS, Stolzel F, Berceanu A, Schafer-Eckart K, Peterlin P, Hicheri Y, Rahme R, Raffoux E, Chermat F, Krause SW, Aulitzky WE, Rigaudeau S, Noppeney R, Berthon C, Gorner M, Jost E, Carassou P, Keller U, Orvain C, Braun T, Saillard C, Arar A, Kunzmann V, Wemeau M, De Wit M, Niemann D, Bonmati C, Schwanen C, Abraham J, Aljijakli A, Haiat S, Kramer A, Reichle A, Gnadler M, Willekens C, Spiekermann K, Hiddemann W, Muller-Tidow C, Thiede C, Rollig C, Serve H, Bornhauser M, Baldus CD, Lengfelder E, Fenaux P, Platzbecker U, Ades L. Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative study. Haematologica. 2021 Dec 1;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.

    PMID: 34047178DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Uwe Platzbecker, Prof. Dr.

CONTACT

+49 351 458 3192Uwe.Platzbecker@medizin.uni-leipzig.de

Michaela Weier

CONTACT

+49 351 458 3192michaela.weier@ukdd.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 17, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

DE(1)