Brief Title
Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia
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
Brief 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.
Detailed 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.
Study Type
Observational
Primary Outcome
Clinical significance on each of the SF-36 questionnaire scales.
Secondary Outcome
Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.
Condition
Acute Promyelocytic Leukemia
Intervention
Health Related Quality of Life (HRQOL) measures
Study Arms / Comparison Groups
Patients being studied
Description: APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Start Date
February 2013
Completion Date
July 2014
Primary Completion Date
July 2014
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Fabio Efficace, PhD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01910623
Organization ID
QOL-APL0512
Responsible Party
Sponsor
Study Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor
Fabio Efficace, PhD, Principal Investigator, GIMEMA Foundation
Verification Date
October 2014