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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04697160
Acronym
RE-MIND2
Enrollment
3573
Registered
2021-01-06
Start date
2020-04-01
Completion date
2021-05-07
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B Cell Lymphoma

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

MorphoSys AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligibility Criteria: 1. Age ≥ 18 years at the initial DLBCL diagnosis. 2. 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. 3. 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: 1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis. 2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy. 3. Patients who underwent an allogeneic stem cell transplant. 4. 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: 1. basal cell carcinoma of the skin 2. squamous cell carcinoma of the skin 3. carcinoma in situ of the cervix 4. carcinoma in situ of the breast 5. carcinoma in situ of the bladder 6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis \[TNM\] stage of T1a or T1b) 5. Patients who received tafasitamab.

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)through study completion, an average of 1 year

Secondary

MeasureTime frame
Duration of Response (DoR)through study completion, an average of 1 year
Event Free Survival (EFS)through study completion, an average of 1 year
Overall/Objective Response Rate (ORR)through study completion, an average of 1 year
Complete Response Rate (CR)through study completion, an average of 1 year
Progression Free Survival (PFS)through study completion, an average of 1 year
Time to next treatment (TTNT)through study completion, an average of 1 year
Treatment discontinuation rate due to adverse eventsthrough study completion, an average of 1 year
Duration of treatment exposurethrough study completion, an average of 1 year

Countries

Australia, Austria, Canada, Denmark, France, Germany, Italy, South Korea, Spain, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026