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Trial record 1 of 138 for:    "acute promyelocytic leukemia"
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Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

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ClinicalTrials.gov Identifier: NCT03096496
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment
Acute Promyelocytic Leukemia Other: QoL questionnaires

Study Type : Observational
Estimated Enrollment : 276 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096496


Contacts
Contact: Francesca Tartaglia +39 06.70390521 f.tartaglia@gimema.it
Contact: Fabio Efficace +39 06.70390521 f.efficace@gimema.it

Locations
Italy
UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno Recruiting
Ascoli Piceno, Italy
Contact: Catia Bigazzi         
Principal Investigator: Catia Bigazzi         
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia Recruiting
Brescia, Italy
Contact: Erika Borlenghi         
Principal Investigator: Erika Borlenghi         
Sub-Investigator: Mara Cecconi         
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze MEdiche Sezione di Ematologia e Fisiopatologia dell'Emostasi Recruiting
Cona, Italy
Contact: Antonio Cuneo         
Principal Investigator: Antonio Cuneo         
Sub-Investigator: Luca Formigaro         
AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia Recruiting
Messina, Italy
Contact: Caterina Musolino         
Principal Investigator: Caterina Musolino         
Sub-Investigator: Demetrio Gerace         
Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico Recruiting
Milano, Italy
Contact: Agostino CORTELEZZI, Pr.         
Principal Investigator: Agostino CORTELEZZI, Pr.         
Sub-Investigator: Eleonora Ferretti, Dr.         
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano Recruiting
Milano, Italy
Contact: Agostino Cortelezzi         
Principal Investigator: Agostino Cortelezzi         
UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele Recruiting
Milano, Italy
Contact: Fabio Ciceri         
Principal Investigator: Fabio Ciceri         
Sub-Investigator: Elena Gucciari         
UO Ematologia - AOU Policlinico di Modena Recruiting
Modena, Italy
Contact: Mario Luppi         
Principal Investigator: Mario Luppi         
Sub-Investigator: Fabio Forghieri         
SCDU Medicina Interna a indirizzo ematologico Recruiting
Orbassano, Italy
Contact: Angelo Guerrasio         
Principal Investigator: Angelo Guerrasio         
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani Recruiting
Pagani, Italy
Contact: Catello Califano         
Principal Investigator: Catello Califano, Dr.         
Sub-Investigator: Flavia Rivellini, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Recruiting
Palermo, Italy
Contact: Francesco Fabbiano         
Principal Investigator: Francesco Fabbiano         
Sub-Investigator: Rosaria Felice         
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy
Contact: Patrizia Zappasodi, Dr.       p.zappasodi@smatteo.pv.it   
Principal Investigator: Patrizia Zappasodi, Dr.         
Sub-Investigator: Gabriele Annino, Dr.         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Simona Sica         
Principal Investigator: Simona Sica         
Sub-Investigator: Federica Sorà         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy
Contact: Nicola Cascavila, Pr.       n.cascavilla@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, Pr.         
Principal Investigator: Lorella Melillo, Dr.         
Ematologia - Dipartimento di Medicina Clinica e Sperimentale Recruiting
Sassari, Italy
Contact: Claudio Fozza         
Principal Investigator: Claudio Fozza         
Sub-Investigator: Francesco Longu         
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista Recruiting
Torino, Italy
Contact: Stefano D'Ardia         
Sub-Investigator: Barbara Amato         
Principal Investigator: Stefano D'Ardia         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Fabio Efficace GIMEMA Foundation

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03096496     History of Changes
Other Study ID Numbers: QoL-APL0816
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Quality of life
acute promyelocytic leukemia
ATO

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid