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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIMEMA APL0406 patients | APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QoL questionnaires | Other | Quality of life questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Efficace | GIMEMA Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno | Ascoli Piceno | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39438322 | Derived | Efficace F, Sparano F, Breccia M, Greco C, Carluccio P, Borlenghi E, Salutari P, Levato L, Baldi T, Mancini V, Finizio O, Autore F, Fazi P, Platzbecker U, Vignetti M, Voso MT. Health-related quality of life benefits of arsenic trioxide in patients with non-high-risk acute promyelocytic leukemia are sustained over time: long-term results of the GIMEMA APL0406 trial. Ann Hematol. 2024 Dec;103(12):5341-5349. doi: 10.1007/s00277-024-06038-7. Epub 2024 Oct 23. | |
| 34529768 |
| Label | URL |
|---|---|
| GIMEMA Foundation website | View source |
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| 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. |
| 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. |
| 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. |
| 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. |
| 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 | Milan | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano | Milan | Italy |
| UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele | Milan | 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 | Italy |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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