Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia Clinical Trial

— QOL-APL0512  

Official title:

Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia: a Follow-up Observational Study of Patients Enrolled in the GIMEMA AIDA 0493 and AIDA 200

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910623
• Other study ID #: QOL-APL0512
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: October 1, 2014
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life.

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.

Description:

This study will focus on long-term survivors as defined by the America Cancer Society, that is surviving the initial diagnosis for more than 5 years. Previous research has investigated long-term Health Related Quality of Life (HRQOL) in patients with acute myeloid leukemia, however, this will be the first research conducted to investigate long-term HRQOL outcomes in patients with acute promyelocytic leukemia (APL).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• APL patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000 surviving the initial diagnosis for more than 5 years and are in CR.

• Written informed consent provided.

• Adult patients at the time of registration onto this study.

Exclusion Criteria:

• Concomitant major psychiatric disorders or cognitive dysfunctions that would interfere with a self-reported evaluation.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Other:
• Health Related Quality of Life (HRQOL) measures

Locations

Country	Name	City	State
Italy	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	Firenze
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"	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical significance on each of the SF-36 questionnaire scales.	This will be performed by using HRQOL scores available for the Italian population. This will help identify which specific areas are mostly impaired and to what extent these patients recover in terms of HRQOL over the long run. This kind of comparison, which is only possible when HRQOL cultural-based norms are available, is largely used when investigating long-term HRQOL in cancer survivors and it is widely recognized as one of the most valuable approach in this kind of research setting.	One month from study entry.	No
Secondary	Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.		One month from study entry.	No
Secondary	Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials.		One month from study entry.	No
Secondary	Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials.		One month from study entry.	No
Secondary	Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials.		One month from study entry	No
Secondary	Possible differences in EORTC-QLQC30, MDASI and SF-36 scales between patients who were less than eighteen years old at the time of diagnosis and patients who were at least eighteen years old at the time of diagnosis.		One month from study entry	No