NCT03096496

Brief Summary

This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

January 24, 2017

Last Update Submit

February 3, 2021

Conditions

Acute Promyelocytic Leukemia

Keywords

Quality of lifeacute promyelocytic leukemiaATO

Outcome Measures

Primary Outcomes (1)

  • To examine cross-sectional long-term differences in health outcomes after treatment end.

    Indicated by selected key-QoL outcomes (i.e. Fatigue, Cognitive and Role functioning scales from the EORTC-QLQ-C30 questionnaire), between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.

    Two years after study entry.

Secondary Outcomes (5)

  • To examine long-term differences in health outcomes after treatment end indicated by all QoL outcomes not considered in primary objectives, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.

    Two years after study entry.

  • To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end.

    Two years after study entry.

  • To compare the long-term QoL profile, after treatment end, of APL patients treated with ATRA- chemotherapy and ATRA-ATO with that of their peers in the general population.

    Two years after study entry.

  • To assess and compare the cumulative incidence and types of physician-reported late adverse effects (e.g. cardiac function) and secondary cancer, between randomized treatment groups.

    Two years after study entry.

  • To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups.

    Two years after study entry.

Other Outcomes (1)

  • To assess long-term QoL patterns over time of long-term APL survivors.

    Two years after study entry.

Study Arms (1)

GIMEMA APL0406 patients

APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.

Other: QoL questionnaires

Interventions

QoL questionnairesOTHER

Quality of life questionnaires

GIMEMA APL0406 patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients previously enrolled in a phase III randomized controlled trial that compared the efficacy and toxicity of standard ATRA plus chemotherapy versus ATRA plus ATO in low-intermediate risk APL patients.

You may qualify if:

  • APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR after third consolidation treatment
  • Written informed consent.

You may not qualify if:

  • APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who are lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno

Ascoli Piceno, Italy

Location

Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia

Brescia, Italy

Location

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze MEdiche Sezione di Ematologia e Fisiopatologia dell'Emostasi

Cona, Italy

Location

AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia

Messina, Italy

Location

Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

Milan, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano

Milan, Italy

Location

UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele

Milan, Italy

Location

UO Ematologia - AOU Policlinico di Modena

Modena, Italy

Location

SCDU Medicina Interna a indirizzo ematologico

Orbassano, Italy

Location

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

Pagani, Italy

Location

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Location

S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, Italy

Location

Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Torino, Italy

Location

Related Publications (2)

  • Efficace F, Sparano F, Breccia M, Greco C, Carluccio P, Borlenghi E, Salutari P, Levato L, Baldi T, Mancini V, Finizio O, Autore F, Fazi P, Platzbecker U, Vignetti M, Voso MT. Health-related quality of life benefits of arsenic trioxide in patients with non-high-risk acute promyelocytic leukemia are sustained over time: long-term results of the GIMEMA APL0406 trial. Ann Hematol. 2024 Dec;103(12):5341-5349. doi: 10.1007/s00277-024-06038-7. Epub 2024 Oct 23.

    PMID: 39438322DERIVED

  • Efficace F, Platzbecker U, Breccia M, Cottone F, Carluccio P, Salutari P, Di Bona E, Borlenghi E, Autore F, Levato L, Finizio O, Mancini V, D'Ardia S, Schlenk RF, Melillo L, Fumagalli M, Fiedler W, Beltrami G, Fracchiolla NS, Bernardi M, Fazi P, Annibali O, Mayer K, Voso MT, Vignetti M. Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy. Blood Adv. 2021 Nov 9;5(21):4370-4379. doi: 10.1182/bloodadvances.2021004649.

    PMID: 34529768DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fabio Efficace

    GIMEMA Foundation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

March 30, 2017

Study Start

March 27, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

IT(16)