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Completed

NCT Number: NCT04150328

Lenalidomide Monotherapy in R/R DLBCL

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)

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MorphoSys Research Site, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Best overall/objective response rate (ORR)

    Time frame: Through study completion, an average of 9 months

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

Secondary outcomes

  1. Overall survival

    Time frame: Through study completion, an average of 9 months

    Time from treatment start until death from any cause

  2. Complete response rate

    Time frame: Through study completion, an average of 9 months

    Proportion of patients having CR based on the best objective response achieved at any time during the study

  3. Disease control rate

    Time frame: Through study completion, an average of 9 months

    Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study

Sponsors and collaborators

Lead sponsor

MorphoSys AG

Industry

Registry information

Official study 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)

Acronym: RE-MIND

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 4, 2019
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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