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
Verified date | February 2021 |
Source | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Malattie EMatologiche dell'Adulto |
Italy,
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. |
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