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Completed

NCT Number: NCT04697160

Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL

To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

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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, Adelaide, Australia

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About this study

This retrospective observational cohort study aims to generate a historical control consisting of R/R DLBCL patients who received currently guideline recommended therapies.

Who can participate

Healthy volunteers accepted: No

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

Eligibility Criteria:

  • Age ≥ 18 years at the initial DLBCL diagnosis.
  • One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
  • Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.

Non-Eligibility Criteria:

  • Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
  • Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
  • Patients who underwent an allogeneic stem cell transplant.
  • Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.

Note: Patients with the following malignancies within the 5 years period are still eligible:

  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • carcinoma in situ of the cervix
  • carcinoma in situ of the breast
  • carcinoma in situ of the bladder
  • incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b)
  • Patients who received tafasitamab.

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Overall/Objective Response Rate (ORR)

    Time frame: through study completion, an average of 1 year

  2. Complete Response Rate (CR)

    Time frame: through study completion, an average of 1 year

  3. Duration of Response (DoR)

    Time frame: through study completion, an average of 1 year

  4. Event Free Survival (EFS)

    Time frame: through study completion, an average of 1 year

  5. Progression Free Survival (PFS)

    Time frame: through study completion, an average of 1 year

  6. Time to next treatment (TTNT)

    Time frame: through study completion, an average of 1 year

  7. Treatment discontinuation rate due to adverse events

    Time frame: through study completion, an average of 1 year

  8. Duration of treatment exposure

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

MorphoSys AG

Industry

Registry information

Official study title

An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study

Acronym: RE-MIND2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Oct 20, 2021

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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