- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611959
Transformed Waldenström Macroglobulineamia (tWM)
Transformed Waldenström Macroglobulinaemia: Clinical Presentation and Outcome. A Multi-institutional Retrospective Study of 77 Cases From the French Innovative Leukemia Organization (FILO)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Reims, France, 51092
- CHU Reims
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Description of clinical and biological features, therapeutic approaches, and clinical outcomes of patients with transformed Waldenstrom macroglobulineamia
Time Frame: 21 years
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21 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prognostic factor of progression-free survival (the time from diagnosis of histological transformation until progression, death from any cause or last follow-up)
Time Frame: 21 years
|
21 years
|
Prognostic factor of overall survival (the time from diagnosis of histological transformation until death from any cause or last follow-up)
Time Frame: 21 years
|
21 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017Ao004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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