Clinical Trial: Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy

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 Summary:
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Current Primary Outcome: To examine long-term differences in health outcomes after treatment end. [ Time Frame: Two years after study entry. ]

Indicated by selected key-QoL outcomes, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. [ Time Frame: 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. [ Time Frame: Two years after study entry. ]
    (as reported at 3rd consolidation).
  • 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. [ Time Frame: Two years after study entry. ]
    Compared with the general population (without cancer).
  • 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. [ Time Frame: 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. [ Time Frame: Two years after study entry. ]
    (ATRA plus chemotherapy versus ATRA plus ATO).


Original Secondary Outcome:

Information By: Gruppo Italiano Malattie EMatologiche dell'Adulto

Dates:
Date Received: January 24, 2017
Date Started: April 2017
Date Completion: February 2019
Last Updated: May 23, 2017
Last Verified: May 2017