Lenalidomide Monotherapy in R/R DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

— RE-MIND  

Official title:

An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150328
• Other study ID #: MOR208C206
• Status: Completed
• Start date: April 12, 2019
• Est. completion date: August 25, 2020

Study information

• Verified date: August 2022
• Source: MorphoSys AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
France	MorphoSys Research Site	Bordeaux
France	MorphoSys Research Site	Le Mans
France	MorphoSys Research Site	Lille
France	MorphoSys Research Site	Lyon
France	MorphoSys Research Site	Paris
France	MorphoSys Research Site	Paris
France	MorphoSys Research Site	Poitiers
France	MorphoSys Research Site	Pontoise
France	MorphoSys Research Site	Rouen
France	MorphoSys Research Site	Toulouse
France	MorphoSys Research Site	Tours
Italy	MorphoSys Research Site	Aviano
Italy	MorphoSys Research Site	Bergamo
Italy	MorphoSys Research Site	Bologna
Italy	MorphoSys Research Site	Brescia
Italy	MorphoSys Research Site	Como
Italy	MorphoSys Research Site	Cuneo
Italy	MorphoSys Research Site	Firenze
Italy	MorphoSys Research Site	Meldola
Italy	MorphoSys Research Site	Milano
Italy	MorphoSys Research Site	Milano
Italy	MorphoSys Research Site	Milano
Italy	MorphoSys Research Site	Modena
Italy	MorphoSys Research Site	Napoli
Italy	MorphoSys Research Site	Napoli
Italy	MorphoSys Research State	Novara
Italy	MorphoSys Research Site	Padova
Italy	MorphoSys Research Site	Parma
Italy	MorphoSys Research Site	Pavia
Italy	MorphoSys Research Site	Perugia
Italy	MorphoSys Research Site	Piacenza
Italy	MorphoSys Research Site	Ponderano
Italy	MorphoSys Research Site	Ravenna
Italy	MorphoSys Research Site	Reggio Emilia
Italy	MorphoSys Research Site	Rimini
Italy	MorphoSys Research Site	Roma
Italy	MorphoSys Research Site	Roma
Italy	MorphoSys Research Site	Roma
Italy	MorphoSys Research Site	Salerno
Italy	MorphoSys Research Site	San Giovanni Rotondo
Italy	MorphoSys Research Site	Torino
Italy	MorphoSys Research Site	Torino
Italy	MorphoSys Research Site	Torino
Italy	MorphoSys Research Site	Udine
Italy	MorphoSys Research Site	Verona
Italy	MorphoSys Research Site	Vicenza
Spain	MorphoSys Research Site	Barcelona
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Salamanca
United States	MorphoSys Research Site	Charleston	South Carolina
United States	MorphoSys Research Site	Dublin	Ohio
United States	MorphoSys Research Site	Greenville	South Carolina
United States	MorphoSys Research Site	Manhasset	New York
United States	MorphoSys Research Site	New York	New York
United States	MorphoSys Research Site	Rochester	New York
United States	MorphoSys Research Site	Rochester	Minnesota
United States	MorphoSys Research Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MorphoSys AG

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Time from treatment start until death from any cause	Through study completion, an average of 9 months
Secondary	Complete response rate	Proportion of patients having CR based on the best objective response achieved at any time during the study	Through study completion, an average of 9 months
Secondary	Disease control rate	Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study	Through study completion, an average of 9 months