Clinical trial NCT04150328: Lenalidomide Monotherapy in R/R DLBCL
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: MorphoSys AG
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 490
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: R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Best overall/objective response rate (ORR)
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Overall survival
timeFrame: Through study completion, an average of 9 months
measure: Complete response rate
timeFrame: Through study completion, an average of 9 months
measure: Disease control rate
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: MorphoSys Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: MorphoSys Research Site
state: Missouri
city: Manhasset
country: United States
facility: MorphoSys Research Site
state: New York
city: New York
country: United States
facility: MorphoSys Research Site
state: New York
city: Rochester
country: United States
facility: MorphoSys Research Site
state: New York
city: Dublin
country: United States
facility: MorphoSys Research Site
state: Ohio
city: Charleston
country: United States
facility: MorphoSys Research Site
state: South Carolina
city: Greenville
country: United States
facility: MorphoSys Research Site
state: South Carolina
city: Bordeaux
country: France
facility: MorphoSys Research Site
city: Le Mans
country: France
facility: MorphoSys Research Site
city: Lille
country: France
facility: MorphoSys Research Site
city: Lyon
country: France
facility: MorphoSys Research Site
city: Paris
country: France
facility: MorphoSys Research Site
city: Paris
country: France
facility: MorphoSys Research Site
city: Poitiers
country: France
facility: MorphoSys Research Site
city: Pontoise
country: France
facility: MorphoSys Research Site
city: Rouen
country: France
facility: MorphoSys Research Site
city: Toulouse
country: France
facility: MorphoSys Research Site
city: Tours
country: France
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: Brescia
country: Italy
facility: MorphoSys Research Site
city: Como
country: Italy
facility: MorphoSys Research Site
city: Cuneo
country: Italy
facility: MorphoSys Research Site
city: Firenze
country: Italy
facility: MorphoSys Research Site
city: Meldola
country: Italy
facility: MorphoSys Research Site
city: Milano
country: Italy
facility: MorphoSys Research Site
city: Milano
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: Napoli
country: Italy
facility: MorphoSys Research Site
city: Novara
country: Italy
facility: MorphoSys Research State
city: Padova
country: Italy
facility: MorphoSys Research Site
city: Parma
country: Italy
facility: MorphoSys Research Site
city: Pavia
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 Emilia
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: Salerno
country: Italy
facility: MorphoSys Research Site
city: San Giovanni Rotondo
country: Italy
facility: MorphoSys Research Site
city: Torino
country: Italy
facility: MorphoSys Research Site
city: Torino
country: Italy
facility: MorphoSys Research Site
city: Torino
country: Italy
facility: MorphoSys Research Site
city: Udine
country: Italy
facility: MorphoSys Research Site
city: Verona
country: Italy
facility: MorphoSys Research Site
city: Vicenza
country: Italy
facility: MorphoSys Research Site
city: Barcelona
country: Spain
facility: MorphoSys Research Site
city: Madrid
country: Spain
facility: MorphoSys Research Site
city: Salamanca
country: Spain
facility: MorphoSys Research Site
Study officials:
References: