Transformed Waldenström Macroglobulineamia

Transformed Waldenström Macroglobulineamia Clinical Trial

— tWM  

Official title:

Transformed Waldenström Macroglobulinaemia: Clinical Presentation and Outcome. A Multi-institutional Retrospective Study of 77 Cases From the French Innovative Leukemia Organization (FILO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611959
• Other study ID #: 2017Ao004
• Status: Completed
• Start date: January 1995
• Est. completion date: January 2016

Study information

• Verified date: July 2018
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transformed Waldenström Macroglobulineamia
• Waldenstrom Macroglobulinemia

Intervention

Other:
• Non Applicable

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Durot E, Tomowiak C, Michallet AS, Dupuis J, Hivert B, Leprêtre S, Toussaint E, Godet S, Merabet F, Van Den Neste E, Ivanoff S, Roussel X, Zini JM, Regny C, Lemal R, Sutton L, Perrot A, Le Dû K, Kanagaratnam L, Morel P, Leblond V, Delmer A. Transformed Waldenström macroglobulinaemia: clinical presentation and outcome. A multi-institutional retrospective study of 77 cases from the French Innovative Leukemia Organization (FILO). Br J Haematol. 2017 Nov;179(3):439-448. doi: 10.1111/bjh.14881. Epub 2017 Aug 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of clinical and biological features, therapeutic approaches, and clinical outcomes of patients with transformed Waldenstrom macroglobulineamia		21 years
Secondary	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
Secondary	Prognostic factor of overall survival (the time from diagnosis of histological transformation until death from any cause or last follow-up)		21 years