Early Detection and Screening of Hematological Malignancies - SANGUINE — SANGUINE  

Hematologic Malignancy Clinical Trial

Official title: Early Detection and Screening of Hematological Malignancies - SANGUINE

Status Recruiting

Clinical Trial Summary

This is a multicenter, open-label, non-interventional controlled study to identify and characterize the epigenetic signatures for a set of hematological malignancies: Multiple myeloma (MM), pre-MM conditions [smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS)], Hodgkin lymphoma (HL), non-Hodgkin aggressive lymphoma NHL [diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), Marginal Zone Lymphoma (MZL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and subjects at risk and control subjects with no malignant disease.

Clinical Trial Description

Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood sample will be obtained.

Periodical blood samples will be obtained from the participants. Relapse patients will have their retrospective blood samples analyzed to identify early signs of disease.

The first stage (discovery phase) will include at least 30 patients from each of the following groups: MM, pre-MM conditions (SMM and MGUS), HL, aggressive NHL (DLBCL, HGL, FL, and MZL transformed to large cell lymphoma), FL, MZL, AML, MDS, and control subjects with no malignant disease.

In the second stage, at least 250 patients with MM and 250 patients with NHL, and at least 100 patients with each of the remaining hematological malignancies mentioned above will be tested. Out of these patients, AML, lymphoma and MM patients will be followed-up at the clinical sites. Periodic sampling will be defined according to disease type and progression rate. Blood and plasma samples will be stored in the clinical sites until relapse diagnosis. At this stage, blood samples will be analyzed retrospectively on the HemaChip. The screening, enrollment and blood collection can begin in the first stage of the trial, in order to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals.

The last stage consists of the screening of a larger group of subjects with a high risk of blood cancer. This stage will include three populations: up to 1000 follow-up patients from each blood cancer: AML, lymphoma, and MM, up to 600 elderly patients (>65 years old) at risk of developing MM, and up to 400 first-degree relatives of patients (and in particular siblings). In order to allow a maximum follow-up period for at-risk subjects as part of the study, and to meet the recruitment goals, the screening, and enrollment can begin in the first stage of the trial.

The last stage consists of screening a larger group of subjects at risk of developing MM / lymphoproliferative disorder. This stage will include 400 elderly patients (>65 years old) and 500 first-degree relatives of patients (and in particular siblings). The screening, enrollment, and sample collection can begin in the first stage of the trial, in order to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals.

In all stages, the age and sex-matched subgroups will be considered and matched.

During the follow-up period, demographic and baseline parameters including sex, age, race, height and weight, medical history, smoking status, details of initial diagnosis and treatment history, concomitant medications as well as adverse events (AEs) of special interest (see section 9.1), (serious) AEs related to study procedures, treatment for the disease, disease response and survival status will be collected (as applicable). ;

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

• NCT number: NCT05735704
• Study type: Observational
• Source: JaxBio Ltd
• Contact: Helena Grinberg-Rashi, PhD
• Phone: +31615636666
• Email: lenagrin@gmail.com
• Status: Recruiting
• Start date: January 30, 2023
• Completion date: January 31, 2026