18 and older, any sex, with Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Best Objective Response Rate (ORR)Primary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation.
ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation.
ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Treatment (MOR00208, Lenalidomide)
46
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Treatment (MOR00208, Lenalidomide)
46
Duration of Response (DoR) by IRC EvaluationSecondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Treatment (MOR00208, Lenalidomide)
43.9
26.1 – NA
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Treatment (MOR00208, Lenalidomide)
NA
33.8 – NA
DoR by Investigator (INV) EvaluationSecondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
43.9
13.9 – NA
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
43.4
14.1 – NA
Progression-free Survival (PFS) by IRC EvaluationSecondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
11.6
6.3 – 45.7
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
11.6
5.7 – 45.7
PFS by INV EvaluationSecondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
9.1
5.5 – 28.0
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
9.1
5.5 – 45.5
Overall Survival (OS)Secondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
33.5
18.3 – NA
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
33.5
18.3 – NA
Disease Control Rate (DCR) by IRC EvaluationSecondary· Approximately 2.5 years after first participant enrolled
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
59
DCR by INV EvaluationSecondary· Approximately 2.5 years after first participant enrolled
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
60
Time to Progression (TTP) by IRC EvaluationSecondary· Approximately 2.5 years after first participant enrolled
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
16.2
7.4 – NA
TTP by INV EvaluationSecondary· Approximately 2.5 years after first participant enrolled
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
14.1
6.3 – NA
Time to Next Treatment (TTNT)Secondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
12.1
7.3 – 24.7
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
12.5
7.3 – 28
Event-free Survival (EFS) by IRC EvaluationSecondary· Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.
Approximately 4.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
8.7
5.3 – 21.0
Approximately 6.5 years after first participant enrolled
Group
Value
95% CI
Tafasitamab (MOR00208) + Lenalidomide (LEN)
9.1
5.3 – 23.5
Adverse events — posted to ClinicalTrials.gov
Time frame: From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (MOR00208, Lenalidomide)
Serious: 47/81 (58%)
Deaths: 45/81
Serious adverse events (67 terms)
Reaction
System
Treatment (MOR00208, Lenal…
Pneumonia
Infections and infestations
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
COVID-19
Infections and infestations
—
Bronchitis
Infections and infestations
—
Lower respiratory tract infection
Infections and infestations
—
Atrial fibrillation
Cardiac disorders
—
Cardiac failure congestive
Cardiac disorders
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07502872 — TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-g
· Phase 2
· not yet recruiting
NCT07030699 — A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma
· Phase 2
· withdrawn
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
· Phase 2
· recruiting
NCT06434363 — Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Di
· Phase 1, PHASE2
· recruiting
NCT06029309 — Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Diffuse Large B-cell Lymphoma
Currently open trials in the same condition.
NCT06977711 — Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large
· Phase 1
· recruiting
NCT06846463 — Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
· Phase 2
· recruiting
NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers
· Phase 1
· active not recruiting
NCT06651853 — Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
· Phase 2
· recruiting
NCT06503263 — Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
· Phase 2
· recruiting
Other MorphoSys AG trials
Trials by the same sponsor.
NCT04697160 — Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL
· completed
NCT04134936 — Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to
· Phase 1
· completed
NCT04150328 — Lenalidomide Monotherapy in R/R DLBCL
· completed
NCT01685008 — Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)
· Phase 2
· completed
NCT04300803 — Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL
· approved for marketing
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MorphoSys AG
Last refreshed: 23 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02399085.