Prognostic analysis for patients with Waldenström's Disease
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.
French Innovative Leukemia Organisation · NCT05911802
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Innovative Leukemia Organisation (other) |
| Locations | 15 sites (Amiens and 14 other locations) |
| Trial ID | NCT05911802 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other chronic lymphoid malignancies or those who do not consent to participate will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens and 14 other locations
- 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)
- LENS - GHT Artois — Lens, France (NOT_YET_RECRUITING)
- LIBOURNE - Hôpital Robert Boulin — Libourne, France (NOT_YET_RECRUITING)
- LILLE GHICL - Hôpital Saint Vincent de Paul — Lille, France (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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Waldenstrom's Disease, Prognostic Index