Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia
NCT ID: NCT01910623
Last Updated: 2014-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
OBSERVATIONAL
2013-02-28
2014-07-31
Brief Summary
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The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these in patients' life.
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Detailed Description
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The potential late effects of cancer treatment can include second malignancies or other chronic conditions affecting physical and emotional well-being. Therefore, there has been an increasing interest worldwide in evaluating the longer-term impact of cancer and its treatment. Currently large cohort of patients enjoys disease-free survival of 5 years or longer. However, a disease-free status is not synonymous with a life free of physical and psychological health related to the cancer and/or its treatment. Research shows that cancer related health concerns persist long after initial treatment and this has been shown in several cancer populations including prostate, testicular, breast cancer and lymphoma patients. Long-term cancer survivors can experience treatment-induced morbidity (e.g. cardiovascular damage due to chemotherapy or radiotherapy; infertility and second tumors), chronic disease and treatment-related symptoms, functional impairment, psychosocial problems, and practical problems.
Since the introduction of the vitamin A derivative all-trans retinoic acid (ATRA) as front-line therapy for APL, the outcome of this acute leukemia subtype has changed from the state of a most frequently fatal leukemia to the condition of a highly curable disease. The Italian cooperative group GIMEMA designed in 1993 the AIDA (Atra plus IDArubicin) trial for newly diagnosed APL. Results on over 800 patients showed a complete remission (CR) rate \> 90% and an overall survival of 76% and confirmed that the concomitant administration of ATRA and chemotherapy is more effective than the sequential administration. Following the identification of distinct prognostic categories among APL patients, the GIMEMA group designed a new trial (AIDA2000) in which the intensity of post-remission treatment was adapted to the relapse risk and 498 patients were enrolled since January 2000. The results recently published showed a CR rate \>90% with molecular remission rate after third consolidation of 98%. The new schedule allowed a Disease Free Survival (DFS) of 86% and showed that a risk-adapted strategy including ATRA for consolidation provides an outcome improvement in newly diagnosed patients. As reported by an international panel of experts, simultaneous ATRA and anthracycline chemotherapy schedules such as those used in the AIDA protocols represent the state of the art therapy for newly diagnosed APL.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients being studied
APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.
Health Related Quality of Life (HRQOL) measures
Interventions
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Health Related Quality of Life (HRQOL) measures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent provided.
* Adult patients at the time of registration onto this study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Fabio Efficace, PhD
Role: PRINCIPAL_INVESTIGATOR
GIMEMA Foundation
Locations
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S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, , Italy
Az.Ospedaliera S.G.Moscati
Avellino, , Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, , Italy
Divisione di Ematologia - Ospedali Riuniti
Bergamo, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, , Italy
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, , Italy
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
Brescia, , Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, , Italy
Policlinico di Careggi
Florence, , Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova, , Italy
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
Genova, , Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina, , Italy
Ospedale Niguarda " Ca Granda"
Milan, , Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena, , Italy
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"
Monza, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, , Italy
Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
Napoli, , Italy
Sez. di Ematologia Clinica Ospedale San Francesco
Nuoro, , Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, , Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, , Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, , Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, , Italy
Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, , Italy
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino, , Italy
Clinica Ematologica - Policlinico Universitario
Udine, , Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, , Italy
ULSS N.6 Osp. S. Bortolo
Vicenza, , Italy
Countries
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Other Identifiers
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QOL-APL0512
Identifier Type: -
Identifier Source: org_study_id
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