Transformed Waldenström Macroglobulineamia (tWM)

July 27, 2018 updated by: CHU de Reims

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 were included in the study

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
21 years

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

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 1995

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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