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

February 3, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno
      • Brescia, Italy
        • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
      • Cona, Italy
        • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
      • Messina, Italy
        • AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia
      • Milano, 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
      • Modena, Italy
        • UO Ematologia - AOU Policlinico di Modena
      • Orbassano, Italy
        • SCDU Medicina Interna a indirizzo ematologico
      • Pagani, Italy
        • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
      • Palermo, Italy
        • Ospedali Riuniti "Villa Sofia-Cervello"
      • Pavia, Italy
        • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Ematologia - Dipartimento di Medicina Clinica e Sperimentale
      • Torino, Italy
        • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GIMEMA APL0406 patients
APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.
Other: QoL questionnaires
Quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To examine cross-sectional long-term differences in health outcomes after treatment end.
Time Frame: 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.
Two years after study entry.

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Two years after study entry.
(including the functional status and symptomatology).
Two years after study entry.
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).
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.
Time Frame: Two years after study entry.
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.
Time Frame: Two years after study entry.
(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.
Time Frame: Two years after study entry.
(ATRA plus chemotherapy versus ATRA plus ATO).
Two years after study entry.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess long-term QoL patterns over time of long-term APL survivors.
Time Frame: Two years after study entry.
After treatment end, overall and by treatment group.
Two years after study entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 27, 2017

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (ACTUAL)

March 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL-APL0816

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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