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

Acute Promyelocytic Leukemia Clinical Trial

Official title:

Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03096496
• Other study ID #: QoL-APL0816
• Status: Active, not recruiting
• Start date: March 27, 2017
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 161
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Other:
• QoL questionnaires
Quality of life questionnaires

Locations

Country	Name	City	State
Italy	UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno	Ascoli Piceno
Italy	Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia	Brescia
Italy	Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze MEdiche Sezione di Ematologia e Fisiopatologia dell'Emostasi	Cona
Italy	AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia	Messina
Italy	Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano	Milano
Italy	UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele	Milano
Italy	UO Ematologia - AOU Policlinico di Modena	Modena
Italy	SCDU Medicina Interna a indirizzo ematologico	Orbassano
Italy	U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani	Pagani
Italy	Ospedali Riuniti "Villa Sofia-Cervello"	Palermo
Italy	S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma
Italy	Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Ematologia - Dipartimento di Medicina Clinica e Sperimentale	Sassari
Italy	Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess long-term QoL patterns over time of long-term APL survivors.	After treatment end, overall and by treatment group.	Two years after study entry.
Primary	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	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.	(including the functional status and symptomatology).	Two years after study entry.
Secondary	To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end.	(as reported at 3rd consolidation).	Two years after study entry.
Secondary	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.	Compared with the general population (without cancer).	Two years after study entry.
Secondary	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.	(ATRA plus chemotherapy versus ATRA plus ATO).	Two years after study entry.
Secondary	To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups.	(ATRA plus chemotherapy versus ATRA plus ATO).	Two years after study entry.

External Links

•   GIMEMA Foundation website