Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

NCT ID: NCT03096496

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-27

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Promyelocytic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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GIMEMA APL0406 patients

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

QoL questionnaires

Intervention Type OTHER

Quality of life questionnaires

Interventions

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QoL questionnaires

Quality of life questionnaires

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Efficace

Role: STUDY_CHAIR

GIMEMA Foundation

Locations

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

Ascoli Piceno, , Italy

Site Status

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

Brescia, , Italy

Site Status

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

Cona, , Italy

Site Status

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

Messina, , Italy

Site Status

Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

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

Milan, , Italy

Site Status

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

Milan, , Italy

Site Status

UO Ematologia - AOU Policlinico di Modena

Modena, , Italy

Site Status

SCDU Medicina Interna a indirizzo ematologico

Orbassano, , Italy

Site Status

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

Pagani, , Italy

Site Status

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, , Italy

Site Status

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

Pavia, , Italy

Site Status

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Site Status

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, , Italy

Site Status

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

Torino, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 39438322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34529768 (View on PubMed)

Related Links

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http://www.gimema.it

GIMEMA Foundation website

Other Identifiers

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QoL-APL0816

Identifier Type: -

Identifier Source: org_study_id

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