Evaluation of Long-term Health Status and Quality of Life in Adult Survivors With Philadelphia-negative Acute Lymphoblastic Leukemia/Lymphoma Treated With an Intensive Pediatric or Pediatric-inspired Protocol (EQUAALL01)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Acute Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT04677231

P150969J

Details and patient eligibility

About

The overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. This approach led to a global improvement in overall survival (5y-OS, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-TRM in patients > 45y, 19%). Pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. This study aims to evaluate the impact in term of long-term events and QoL in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. The main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for ALL/LL with an intensified pediatric-inspired protocol (GRAALL2003/05-LL03-FRALLE2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. One of the secondary endpoint of the study is to assess quality of life of these patients.

Enrollment: 300 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with Philadelphia-negative ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
• Patients older than 15 years old and less than 60 years old at diagnosis
• Patient with a follow-up from first complete remission of more than 10 years,
• Patient who gave informed signed consent for baseline examination

Exclusion criteria

• Patient who experienced ALL/LL relapse within the 5 past years.
• Philadelphia positive ALL patients