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

NCT04677231 | Unknown

• 1 other identifier: P150969J
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Acute Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevalence of metabolic 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.

• 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.

• 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.

• 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.

• 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.

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 15-59y at diagnosis treated ten years ago for a Ph1-negative acute lymphoblastic leukemia/lymphoma (ALL/LL)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Nicolas BOISSEL, Pr

CONTACT

+33142499643; nicolas.boissel@aphp.fr

Matthieu Resche-Rigon

CONTACT

+33142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 21, 2020

Record last verified: 2020-12