NCT04150328

Brief Summary

This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
4 countries

57 active sites

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

April 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

October 31, 2019

Last Update Submit

August 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Best overall/objective response rate (ORR)

    Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study

    Through study completion, an average of 9 months

Secondary Outcomes (3)

  • Overall survival

    Through study completion, an average of 9 months

  • Complete response rate

    Through study completion, an average of 9 months

  • Disease control rate

    Through study completion, an average of 9 months

Eligibility Criteria

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

R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy

You may qualify if:

  • Histologically confirmed diagnosis of DLBCL
  • Relapsed/refractory to at least one previous systemic therapy for DLBCL
  • Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
  • Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT

You may not qualify if:

  • CNS involvement by lymphoma
  • Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
  • Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
  • Patients who previously underwent allogeneic SCT
  • Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
  • Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

MorphoSys Research Site

Rochester, Minnesota, 55905, United States

Location

MorphoSys Research Site

St Louis, Missouri, 63110, United States

Location

MorphoSys Research Site

Manhasset, New York, 11030, United States

Location

MorphoSys Research Site

New York, New York, 10013, United States

Location

MorphoSys Research Site

Rochester, New York, 14642, United States

Location

MorphoSys Research Site

Dublin, Ohio, 43017, United States

Location

MorphoSys Research Site

Charleston, South Carolina, 29425, United States

Location

MorphoSys Research Site

Greenville, South Carolina, 29615, United States

Location

MorphoSys Research Site

Bordeaux, 76038, France

Location

MorphoSys Research Site

Le Mans, 72037, France

Location

MorphoSys Research Site

Lille, 59037, France

Location

MorphoSys Research Site

Lyon, 69495, France

Location

MorphoSys Research Site

Paris, 75010, France

Location

MorphoSys Research Site

Paris, 75743, France

Location

MorphoSys Research Site

Poitiers, 86000, France

Location

MorphoSys Research Site

Pontoise, 95300, France

Location

MorphoSys Research Site

Rouen, 76038, France

Location

MorphoSys Research Site

Toulouse, 31059, France

Location

MorphoSys Research Site

Tours, 37044, France

Location

MorphoSys Research Site

Aviano, 33081, Italy

Location

MorphoSys Research Site

Bergamo, 24127, Italy

Location

MorphoSys Research Site

Bologna, 40138, Italy

Location

MorphoSys Research Site

Brescia, 25123, Italy

Location

MorphoSys Research Site

Como, 22100, Italy

Location

MorphoSys Research Site

Cuneo, 12100, Italy

Location

MorphoSys Research Site

Florence, 50134, Italy

Location

MorphoSys Research Site

Meldola, 47014, Italy

Location

MorphoSys Research Site

Milan, 20132, Italy

Location

MorphoSys Research Site

Milan, 20141, Italy

Location

MorphoSys Research Site

Milan, 20162, Italy

Location

MorphoSys Research Site

Modena, 41124, Italy

Location

MorphoSys Research Site

Napoli, 80131_2, Italy

Location

MorphoSys Research Site

Napoli, 80131, Italy

Location

MorphoSys Research State

Novara, 28100, Italy

Location

MorphoSys Research Site

Padua, 35128, Italy

Location

MorphoSys Research Site

Parma, 43126, Italy

Location

MorphoSys Research Site

Pavia, 27100, Italy

Location

MorphoSys Research Site

Perugia, 06129, Italy

Location

MorphoSys Research Site

Piacenza, 29121, Italy

Location

MorphoSys Research Site

Ponderano, 13875, Italy

Location

MorphoSys Research Site

Ravenna, 48121, Italy

Location

MorphoSys Research Site

Reggio Emilia, 42132, Italy

Location

MorphoSys Research Site

Rimini, 47923, Italy

Location

MorphoSys Research Site

Roma, 00128, Italy

Location

MorphoSys Research Site

Roma, 00161, Italy

Location

MorphoSys Research Site

Roma, 00189, Italy

Location

MorphoSys Research Site

Salerno, 84131, Italy

Location

MorphoSys Research Site

San Giovanni Rotondo, 71013, Italy

Location

MorphoSys Research Site

Torino, 10126_2, Italy

Location

MorphoSys Research Site

Torino, 10126, Italy

Location

MorphoSys Research Site

Torino, 10128, Italy

Location

MorphoSys Research Site

Udine, 33100, Italy

Location

MorphoSys Research Site

Verona, 37100, Italy

Location

MorphoSys Research Site

Vicenza, 36100, Italy

Location

MorphoSys Research Site

Barcelona, 08003, Spain

Location

MorphoSys Research Site

Madrid, 28041, Spain

Location

MorphoSys Research Site

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

April 12, 2019

Primary Completion

August 25, 2019

Study Completion

August 25, 2020

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations