Clinical trial Recruiting at 1 site Observational Ages 18 and up

Prognostic analysis for patients with Waldenström's Disease

Official title: Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease: Validation of International Prognostic Indexes, Evaluation of Progression-free Survival as a Surrogate Endpoint for Overall Survival. A FILO Study.

Run by French Innovative Leukemia Organisation · NCT05911802 · Data updated 2026-11-12

This study looks at patients with Waldenström's Disease to see if certain blood tests can help predict how their condition will progress and how they will respond to treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorFrench Innovative Leukemia Organisation
Academic / other
Locations15 sites (Amiens and 14 other locations)
StatusRecruiting
StartedAugust 11, 2023
Main results expectedJune 15, 2030
Study endsJune 15, 2030
Registry record updatedNovember 26, 2025
Trial IDNCT05911802 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with Waldenström's Disease who meet specific diagnostic criteria and can commit to long-term follow-up.

Probably not a fit

Patients with other chronic lymphoid malignancies or those who do not consent to participate will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients diagnosed with Waldenström's macroglobulinemia (WM), a condition characterized by lymphoplasmocytic infiltration and high levels of monoclonal immunoglobulin M (IgM). It aims to improve prognostic assessments for asymptomatic patients by evaluating various clinical and molecular factors, including serum albumin and free light chain concentrations. The study will follow patients until at least 2024 to gather comprehensive data on their disease progression and treatment outcomes.

Why it matters

Potential benefit: If successful, this study could lead to better prognostic tools for managing Waldenström's Disease, potentially improving patient outcomes.

How similar studies have gone: While this study builds on existing prognostic indices, its specific focus on asymptomatic patients and molecular characteristics may provide novel insights into the management of Waldenström's Disease.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient with WM, fulfilling the diagnostic criteria defined at the 2nd Workshop on WM.
* Patient in whom follow-up is available until at least 01/01/2020. Each participating center should not enroll more 10% of patients lost to follow-up.
* Patient for whom a minimum annual follow-up is planned until 2024.
* Having given their consent for this study

Exclusion Criteria:

* Patient with other chronic lymphoid malignancy. Special attention will be paid to exclude other lymphoplasmacytic proliferations, especially marginal zone lymphoma.
* Patient with histological transformation in a diffuse large B-cell lymphoma or any other lymphoma at the time of the initiation of the 1st treatment.
* No consent for this study.

Where it's running

  • LILLE GHICL - Hôpital Saint Vincent de Paul
    Lille, France
    Recruiting
  • AMIENS - CH Amiens Picardie Site Sud
    Amiens, France
    Not yet recruiting
  • Angers Chu
    Angers, France
    Not yet recruiting
  • Institut Bergonie
    Bordeaux, France
    Not yet recruiting
  • Clermont-Ferrand - Chu Estaing
    Clermont-Ferrand, France
    Not yet recruiting
  • Le Mans CH
    Le Mans, France
    Not yet recruiting
Show 9 more locations
  • LENS - GHT Artois
    Lens, France
    Not yet recruiting
  • LIBOURNE - Hôpital Robert Boulin
    Libourne, France
    Not yet recruiting
  • Institut Paoli Calmette
    Marseille, France
    Not yet recruiting
  • APHP - Hôpital Pitié Salpêtrière - Hématologie
    Paris, France
    Not yet recruiting
  • POITIERS - Hématologie et Thérapie Cellulaire
    Poitiers, France
    Not yet recruiting
  • Reims Chu
    Reims, France
    Not yet recruiting
  • Strasbourg - Icans
    Strasbourg, France
    Not yet recruiting
  • Toulouse - IUCT Oncopole - Service d'Hématologie
    Toulouse, France
    Not yet recruiting
  • VERSAILLES - Hôpital André Mignot
    Versailles, France
    Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.