NCT07018310

Brief Summary

Hematological malignancy is a disease of the blood. In some cases, this pathology requires therapeutic management, which is not necessarily the case for you. Nevertheless, to improve the management of patients who need it, we are conducting research to assess the state of your immune system. Indeed, the role of the immune system is not limited to controlling infections, but is also important in controlling the proliferation of cancer cells, in hematology as in other types of cancer. Your immune system can play a spontaneous anti-tumor control role, but some so-called "immunotherapy" treatments aim to destroy cancer cells by stimulating the immune system, restoring its capabilities, and directing the immune response against tumor cells. For this immunotherapy treatment to be effective, since it uses your own immune cells (in most cases), these cells must be in a state to respond and be able to destroy the tumor. It is this ability to activate immune cells that is tested in this research protocol, using a simple test that could in future be used in routine clinical practice. But to understand why these immune cells don't work, we will also have to carry out genetic tests to analyze the various molecules that could interfere with the immune response, and try to inhibit the molecules that prevent the immune response.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

June 4, 2025

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentages of immune effectors

    Percentages of immune effectors responding to stimulation, assessed in patients with hematological malignancies

    At the enrollement in the study

Secondary Outcomes (1)

  • Activation percentages (cytometry) vs. polymorphism expression percentage (molecular biology)

    At the enrollement

Study Arms (1)

blood sampling

EXPERIMENTAL

blood sampling in patients with hematological malignancies

Other: blood sampling

Interventions

Additional blood sampling as part of routine care

blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female over 18 years of age
  • Patient with a hematological malignancy likely to benefit from immunotherapy (in any form; at the discretion of the referring physician)
  • Before the start of 1st-line treatment, successive lines or before autograft (chemotherapy-free for at least 4 weeks in these cases).
  • Patient has received information about the study and has not expressed opposition.
  • Patient who is a beneficiary or entitled beneficiary of a social security scheme

You may not qualify if:

  • Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8
  • Minors
  • Adults under legal protection or unable to express their consent.
  • A person who cannot read and understand the French language well enough to be able to consent to take part in research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisitance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Régis Costello Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations