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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | French Innovative Leukemia Organisation Academic / other |
| Locations | 15 sites (Amiens and 14 other locations) |
| Status | Recruiting |
| Started | August 11, 2023 |
| Main results expected | June 15, 2030 |
| Study ends | June 15, 2030 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT05911802 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
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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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.