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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03096496

Enrollment

161

Registered

2017-03-30

Start date

2017-03-27

Completion date

2022-01-31

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Promyelocytic Leukemia

Keywords

Quality of life, acute promyelocytic leukemia, ATO

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.

Interventions

OTHERQoL questionnaires

Quality of life questionnaires

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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).

Other

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026