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

Acute Lymphoblastic Leukemia Clinical Trial

— EQUAALL01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04677231
• Other study ID #: P150969J
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: March 2024

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicolas BOISSEL, Pr
• Phone: +33142499643
• Email: nicolas.boissel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of adverse events	This is a binary, composite, endpoint, including any of the following adverse events: metabolic troubles (dysmetabolic syndrome, dyslipidemia, diabetes); osseous events /osteoporosis; cardiac and vascular troubles; neurologic troubles; lung dysfunctions; endocrinal troubles	Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of metabolic troubles	Metabolic troubles will be defined as dysmetabolic syndrome or dyslipidemia or diabetes	Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of osseous events		Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of cardiac and vascular troubles		Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of neurologic troubles		Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of lung dysfunctions		Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Prevalence of endocrinal troubles		Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary	Quality of Life	Quality of life will be assess using the SF36-questionnaire. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are grouped into three categories: functional status, well-being, overall health assessment. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). For each dimension, the scores for the different items are coded and then summed and transformed linearly on a scale ranging from 0 to 100. A physical composite score and a mental composite score can be calculated according to an established algorithm	Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.