Viewing Study NCT03611959


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Study NCT ID: NCT03611959
Status: COMPLETED
Last Update Posted: 2018-08-02
First Post: 2018-07-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Transformed Waldenström Macroglobulineamia
Sponsor: CHU de Reims
Organization:

Study Overview

Official Title: Transformed Waldenström Macroglobulinaemia: Clinical Presentation and Outcome. A Multi-institutional Retrospective Study of 77 Cases From the French Innovative Leukemia Organization (FILO)
Status: COMPLETED
Status Verified Date: 2018-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: tWM
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: