Transformed Waldenström Macroglobulineamia

Completed

• Conditions: Transformed Waldenström Macroglobulineamia

• Registration Number: NCT03611959
• Lead Sponsor: CHU de Reims

Brief Summary

Histological transformation to diffuse large B-cell lymphoma is a rare complication which may occur in Waldenstrom macroglobulinemia. In this multicenter study, we retrospectively analyzed the clinico-biological features, therapy, outcomes and prognostic factors in 77 Waldenstrom macroglobulinemia patients with biopsy-proven transformation to diffuse large B-cell lymphoma.

Detailed Description

Histological transformation to diffuse large B-cell lymphoma is a rare complication which may occur in Waldenstrom macroglobulinemia. In this multicenter study, we retrospectively analyzed the clinico-biological features, therapy, outcomes and prognostic factors in 77 Waldenstrom macroglobulinemia (WM) patients with biopsy-proven transformation to diffuse large B-cell lymphoma (DLBCL).

We retrospectively searched the databases of French and Belgian centers for patients older than 18 years diagnosed with WM and a concurrent or sequential diagnosis of DLBCL between 1995 and 2016. Nineteen centers belonging to the French Innovative Leukemia Organization (FILO) group participated in this study. Patients with a diagnosis of indolent lymphoma other than WM were excluded. The diagnosis of WM was based on criteria established in the Second International Workshop on WM. Clinical, biological data and prognostic scores were recorded. Quantitative variables were expressed as median and range and qualitative variables as number and percentages. Multivariate analyses using cox proportional hazard model were conducted to investigate the factors independently related to progression-free survival and overall survival.

Study Timeline

• Study Start: 1995-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Last Update Submitted: 2018-07-27
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Patients older than 18 years diagnosed with Waldenstrom macroglobulineamia and a concurrent or sequential diagnosis of diffuse large B-cell lymphoma between 1995 and 2016

Exclusion Criteria

• Patients with a diagnosis of indolent lymphoma other than Waldenstrom macroglobulineamia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of clinical and biological features, therapeutic approaches, and clinical outcomes of patients with transformed Waldenstrom macroglobulineamia	21 years

Secondary Outcome Measures

Name	Time	Method
Prognostic factor of progression-free survival (the time from diagnosis of histological transformation until progression, death from any cause or last follow-up)	21 years
Prognostic factor of overall survival (the time from diagnosis of histological transformation until death from any cause or last follow-up)	21 years

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France