Clinical trial NCT03096496: Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy
Official title: Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Promyelocytic Leukemia
Keywords: Quality of life
acute promyelocytic leukemia
ATO
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To examine cross-sectional long-term differences in health outcomes after treatment end.
timeFrame: Two years after study entry.
Secondary outcomes:
measure: 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.
timeFrame: Two years after study entry.
measure: To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end.
timeFrame: Two years after study entry.
measure: 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.
timeFrame: Two years after study entry.
measure: 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.
timeFrame: Two years after study entry.
measure: To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups.
timeFrame: Two years after study entry.
Other outcomes:
measure: To assess long-term QoL patterns over time of long-term APL survivors.
timeFrame: Two years after study entry.
Locations:
city: Ascoli Piceno
country: Italy
facility: UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno
city: Brescia
country: Italy
facility: Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze MEdiche Sezione di Ematologia e Fisiopatologia dell'Emostasi
city: Messina
country: Italy
facility: AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia
city: Milano
country: Italy
facility: Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano
city: Milano
country: Italy
facility: UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele
city: Modena
country: Italy
facility: UO Ematologia - AOU Policlinico di Modena
city: Orbassano
country: Italy
facility: SCDU Medicina Interna a indirizzo ematologico
city: Pagani
country: Italy
facility: U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
city: Palermo
country: Italy
facility: Ospedali Riuniti "Villa Sofia-Cervello"
city: Pavia
country: Italy
facility: S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Ematologia - Dipartimento di Medicina Clinica e Sperimentale
city: Torino
country: Italy
facility: Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Study officials:
affiliation: GIMEMA Foundation
name: Fabio Efficace
role: STUDY_CHAIR
References:
citation: 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.