Clinical trial · Observational
Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy
Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy
NCT03096496CI-TRIAL-00049916unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QoL questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GIMEMA APL0406 patients
- description
- APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.
- interventionNames
- Other: QoL questionnaires
Primary outcomes (1)
- measure
- To examine cross-sectional long-term differences in health outcomes after treatment end.
- timeFrame
- Two years after study entry.
- description
- 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 outcomes (5)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDEfficace 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. PMID 39438322
- DERIVEDEfficace 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. PMID 34529768