Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia — QOL-APL0512  

Acute Promyelocytic Leukemia Clinical Trial

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

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

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

• NCT number: NCT01910623
• Study type: Observational
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: July 2014