NCT03611959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

21 years

First QC Date

July 27, 2018

Last Update Submit

July 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of clinical and biological features, therapeutic approaches, and clinical outcomes of patients with transformed Waldenstrom macroglobulineamia

    21 years

Secondary Outcomes (2)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

  • Durot E, Tomowiak C, Michallet AS, Dupuis J, Hivert B, Lepretre 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 Du K, Kanagaratnam L, Morel P, Leblond V, Delmer A. Transformed Waldenstrom 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.

    PMID: 28770576BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

January 1, 1995

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations