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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03096496

Collaborator

(none)

161

Enrollment

Locations

57.2

Anticipated Duration (Months)

10.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Promyelocytic Leukemia	Other: QoL questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

161 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 27, 2017

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
GIMEMA APL0406 patients APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.	Other: QoL questionnaires Quality of life questionnaires

Arm

Intervention/Treatment

GIMEMA APL0406 patients

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

Other: QoL questionnaires

Quality of life questionnaires

Outcome Measures

Primary Outcome Measures

To examine cross-sectional long-term differences in health outcomes after treatment end. [Two years after study entry.]
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.

Secondary Outcome Measures

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.]
(including the functional status and symptomatology).
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.]
(as reported at 3rd consolidation).
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.]
Compared with the general population (without cancer).
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.]
(ATRA plus chemotherapy versus ATRA plus ATO).
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.]
(ATRA plus chemotherapy versus ATRA plus ATO).

Other Outcome Measures

To assess long-term QoL patterns over time of long-term APL survivors. [Two years after study entry.]
After treatment end, overall and by treatment group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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