Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy
- Conditions
- Acute Promyelocytic Leukemia
- Registration Number
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 161
- APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR after third consolidation treatment
- Written informed consent.
- APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who are lost to follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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).
Trial Locations
- Locations (16)
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
Scroll for more (6 remaining)UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno🇮🇹Ascoli Piceno, Italy