Clinical trial NCT04697160: Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: MorphoSys AG
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 3573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed or refractory DLBCL

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.

Eligibility 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall/Objective Response Rate (ORR)
timeFrame: through study completion, an average of 1 year
measure: Complete Response Rate (CR)
timeFrame: through study completion, an average of 1 year
measure: Duration of Response (DoR)
timeFrame: through study completion, an average of 1 year
measure: Event Free Survival (EFS)
timeFrame: through study completion, an average of 1 year
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: Time to next treatment (TTNT)
timeFrame: through study completion, an average of 1 year
measure: Treatment discontinuation rate due to adverse events
timeFrame: through study completion, an average of 1 year
measure: Duration of treatment exposure
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: MorphoSys Research Site
state: Arizona
city: Clovis
country: United States
facility: MorphoSys Research Site
state: California
city: Los Angeles
country: United States
facility: MorphoSys Research Site
state: California
city: Orange
country: United States
facility: MorphoSys Research Site
state: California
city: Torrance
country: United States
facility: MorphoSys Research Site
state: California
city: Broomfield
country: United States
facility: MorphoSys Research Site
state: Colorado
city: Chicago
country: United States
facility: MorphoSys Research Site
state: Illinois
city: Skokie
country: United States
facility: MorphoSys Research Site
state: Illinois
city: Indianapolis
country: United States
facility: MorphoSys Research Site
state: Indiana
city: Wichita
country: United States
facility: MorphoSys Research Site
state: Kansas
city: Ann Arbor
country: United States
facility: MorphoSys Research Site
state: Michigan
city: Minneapolis
country: United States
facility: MorphoSys Research Site
state: Minnesota
city: Rochester
country: United States
facility: MorphoSys Research Site
state: Minnesota
city: Jackson
country: United States
facility: MorphoSys Research Site
state: Mississippi
city: Morristown
country: United States
facility: MorphoSys Research Site
state: New Jersey
city: New York
country: United States
facility: MorphoSys Research Site
state: New York
city: New York
country: United States
facility: MorphoSys Research Site
state: New York
city: Charlotte
country: United States
facility: MorphoSys Research Site
state: North Carolina
city: Portland
country: United States
facility: MorphoSys Research Site
state: Oregon
city: Nashville
country: United States
facility: MorphoSys Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: MorphoSys Research Site
state: Utah
city: Spokane
country: United States
facility: MorphoSys Research Site
state: Washington
city: Adelaide
country: Australia
facility: MorphoSys Research Site
city: Benowa
country: Australia
facility: MorphoSys Research Site
city: Concord
country: Australia
facility: MorphoSys Research Site
city: Darlinghurst
country: Australia
facility: MorphoSys Research Site
city: East Melbourne
country: Australia
facility: MorphoSys Research Site
city: Fitzroy
country: Australia
facility: MorphoSys Research Site
city: Frankston
country: Australia
facility: MorphoSys Research Site
city: Kingswood
country: Australia
facility: MorphoSys Research Site
city: Nedlands
country: Australia
facility: MorphoSys Research Site
city: Leoben
country: Austria
facility: MorphoSys Research Site
city: Linz
country: Austria
facility: MorphoSys Research Site
city: Salzburg
country: Austria
facility: MorphoSys Research Site
city: Sankt Pölten
country: Austria
facility: MorphoSys Research Site
city: Wels
country: Austria
facility: MorphoSys Research Site
city: Wien
country: Austria
facility: MorphoSys Research Site
city: Edmonton
country: Canada
facility: MorphoSys Research Site
city: Montréal
country: Canada
facility: MorphoSys Research Site
city: Aalborg
country: Denmark
facility: MorphoSys Research Site
city: Albi
country: France
facility: MorphoSys Research Site
city: Amiens
country: France
facility: MorphoSys Research Site
city: Angers
country: France
facility: MorphoSys Research Site
city: Caen
country: France
facility: MorphoSys Research Site
city: Carcassonne
country: France
facility: MorphoSys Research Site
city: Castres
country: France
facility: MorphoSys Research Site
city: Chambéry
country: France
facility: MorphoSys Research Site
city: Grenoble
country: France
facility: MorphoSys Research Site
city: La Roche-sur-Yon
country: France
facility: MorphoSys Research Site
city: Lille
country: France
facility: MorphoSys Research Site
city: Montpellier
country: France
facility: MorphoSys Research Site
city: Narbonne
country: France
facility: MorphoSys Research Site
city: Nice
country: France
facility: MorphoSys Research Site
city: Nîmes
country: France
facility: MorphoSys Research Site
city: Orléans
country: France
facility: MorphoSys Research Site
city: Paris
country: France
facility: MorphoSys Research Site
city: Paris
country: France
facility: MorphoSys Research Site
city: Perpignan
country: France
facility: MorphoSys Research Site
city: Pessac
country: France
facility: MorphoSys Research Site
city: Pierre-Bénite
country: France
facility: MorphoSys Research Site
city: Quimper
country: France
facility: MorphoSys Research Site
city: Rodez
country: France
facility: MorphoSys Research Site
city: Rouen
country: France
facility: MorphoSys Research Site
city: Saint-Brieuc
country: France
facility: MorphoSys Research Site
city: Saint-Priest-en-Jarez
country: France
facility: MorphoSys Research Site
city: Saint-Quentin
country: France
facility: MorphoSys Research Site
city: Toulouse
country: France
facility: MorphoSys Research Site
city: Tours
country: France
facility: MorphoSys Research Site
city: Troyes
country: France
facility: MorphoSys Research Site
city: Vandœuvre-lès-Nancy
country: France
facility: MorphoSys Research Site
city: Aschaffenburg
country: Germany
facility: MorphoSys Research Site
city: Augsburg
country: Germany
facility: MorphoSys Research Site
city: Bad Liebenwerda
country: Germany
facility: MorphoSys Research Site
city: Donauwörth
country: Germany
facility: MorphoSys Research Site
city: Dresden
country: Germany
facility: MorphoSys Research Site
city: Dresden
country: Germany
facility: MorphoSys Research Site
city: Flensburg
country: Germany
facility: MorphoSys Research Site
city: Frechen
country: Germany
facility: MorphoSys Research Site
city: Freiburg im Breisgau
country: Germany
facility: MorphoSys Research Site
city: Göttingen
country: Germany
facility: MorphoSys Research Site
city: Halle
country: Germany
facility: MorphoSys Research Site
city: Hamburg
country: Germany
facility: MorphoSys Research Site
city: Hannover
country: Germany
facility: MorphoSys Research Site
city: Hannover
country: Germany
facility: MorphoSys Research Site
city: Heidelberg
country: Germany
facility: MorphoSys Research Site
city: Heilbronn
country: Germany
facility: MorphoSys Research Site
city: Köln
country: Germany
facility: MorphoSys Research Site
city: Landshut
country: Germany
facility: MorphoSys Research Site
city: Lebach
country: Germany
facility: MorphoSys Research Site
city: Lübeck
country: Germany
facility: MorphoSys Research Site
city: Mainz
country: Germany
facility: MorphoSys Research Site
city: Münster
country: Germany
facility: MorphoSys Research Site
city: Neustadt
country: Germany
facility: MorphoSys Research Site
city: Oldenburg In Holstein
country: Germany
facility: MorphoSys Research Site
city: Oldenburg
country: Germany
facility: MorphoSys Research Site
city: Potsdam
country: Germany
facility: MorphoSys Research Site
city: Ratingen
country: Germany
facility: MorphoSys Research Site
city: Saarbrücken
country: Germany
facility: MorphoSys Research Site
city: Schorndorf
country: Germany
facility: MorphoSys Research Site
city: Stuttgart
country: Germany
facility: MorphoSys Research Site
city: Villingen Schwenningen
country: Germany
facility: MorphoSys Research Site
city: Villingen-Schwenningen
country: Germany
facility: MorphoSys Research Site
city: Wilhelmshaven
country: Germany
facility: MorphoSys Research Site
city: Wolfsburg
country: Germany
facility: MorphoSys Research Site
city: Alessandria
country: Italy
facility: MorphoSys Research Site
city: Ancona
country: Italy
facility: MorphoSys Research Site
city: Aviano
country: Italy
facility: MorphoSys Research Site
city: Bergamo
country: Italy
facility: MorphoSys Research Site
city: Bologna
country: Italy
facility: MorphoSys Research Site
city: Como
country: Italy
facility: MorphoSys Research Site
city: Cremona
country: Italy
facility: MorphoSys Research Site
city: Firenze
country: Italy
facility: MorphoSys Research Site
city: Lecce
country: Italy
facility: MorphoSys Research Site
city: Milano
country: Italy
facility: MorphoSys Research Site
city: Modena
country: Italy
facility: MorphoSys Research Site
city: Napoli
country: Italy
facility: MorphoSys Research Site
city: Palermo
country: Italy
facility: MorphoSys Research Site
city: Perugia
country: Italy
facility: MorphoSys Research Site
city: Piacenza
country: Italy
facility: MorphoSys Research Site
city: Ponderano
country: Italy
facility: MorphoSys Research Site
city: Ravenna
country: Italy
facility: MorphoSys Research Site
city: Reggio Calabria
country: Italy
facility: MorphoSys Research Site
city: Rimini
country: Italy
facility: MorphoSys Research Site
city: Roma
country: Italy
facility: MorphoSys Research Site
city: Roma
country: Italy
facility: MorphoSys Research Site
city: Roma
country: Italy
facility: MorphoSys Research Site
city: Terni
country: Italy
facility: MorphoSys Research Site
city: Udine
country: Italy
facility: MorphoSys Research Site
city: Vicenza
country: Italy
facility: MorphoSys Research Site
city: Busan
country: Korea, Republic of
facility: MorphoSys Research Site
city: Busan
country: Korea, Republic of
facility: MorphoSys Research Site
city: Seoul
country: Korea, Republic of
facility: MorphoSys Research Site
city: Seoul
country: Korea, Republic of
facility: MorphoSys Research Site
city: Seoul
country: Korea, Republic of
facility: MorphoSys Research Site
city: Ulsan
country: Korea, Republic of
facility: MorphoSys Research Site
city: Badalona
country: Spain
facility: MorphoSys Research Site
city: Barcelona
country: Spain
facility: MorphoSys Research Site
city: Hospitalet de Llobregat
country: Spain
facility: MorphoSys Research Site
city: Lugo
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Majadahonda
country: Spain
facility: MorphoSys Research Site
city: Palma De Mallorca
country: Spain
facility: MorphoSys Research Site
city: Palma De Mallorca
country: Spain
facility: MorphoSys Research Site
city: Pamplona
country: Spain
facility: MorphoSys Research Site
city: Pozuelo De Alarcón
country: Spain
facility: MorphoSys Research Site
city: Sabadell
country: Spain
facility: MorphoSys Research Site
city: Salamanca
country: Spain
facility: MorphoSys Research Site
city: Santander
country: Spain
facility: MorphoSys Research Site
city: Sevilla
country: Spain
facility: MorphoSys Research Site
city: Valencia
country: Spain
facility: MorphoSys Research Site
city: Valencia
country: Spain
facility: MorphoSys Research Site
city: Valladolid
country: Spain
facility: MorphoSys Research Site
city: Valladolid
country: Spain
facility: MorphoSys Research Site
city: Taichung
country: Taiwan
facility: MorphoSys Research Site
city: Tainan
country: Taiwan
facility: MorphoSys Research Site
city: Taipei city
country: Taiwan
facility: MorphoSys Research Site
city: Brighton
country: United Kingdom
facility: MorphoSys Research Site
city: Manchester
country: United Kingdom
facility: MorphoSys Research Site
city: Sunderland
country: United Kingdom
facility: MorphoSys Research Site
city: Taunton
country: United Kingdom
facility: MorphoSys Research Site
city: Truro
country: United Kingdom
facility: MorphoSys Research Site
city: Westcliff-on-Sea
country: United Kingdom
facility: MorphoSys Research Site
Study officials:
affiliation: MorphoSys AG
name: Eva Waltl
role: STUDY_DIRECTOR
References:
citation: Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.