Trial Outcomes & Findings for A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma (NCT NCT05788289)

Last Updated: 2025-05-25

Results Overview

Overall Response Rate/ORR is defined as the percent of participants who achieve Complete Response/CR or Primary Response/PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first

Results posted on

2025-05-25

Participant milestones
Measure	Participants With Mantle Cell Lymphoma Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Participants With Mantle Cell Lymphoma Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Overall Study Death	3

A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma

Baseline characteristics by cohort
Measure	Participants With Mantle Cell Lymphoma n=4 Participants Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Age, Continuous	74 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	4 Participants n=99 Participants

Timeframe: completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first

Overall Response Rate/ORR is defined as the percent of participants who achieve Complete Response/CR or Primary Response/PR

Outcome measures
Measure	Participants With Mantle Cell Lymphoma n=4 Participants Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Overall Response Rate/ORR Participants with response	1 Participants
Overall Response Rate/ORR Participants without response	3 Participants

Serious events: 4 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events
Measure	Participants With Mantle Cell Lymphoma n=4 participants at risk Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Injury, poisoning and procedural complications Infusion related reaction	25.0% 1/4 • 1 year
General disorders Edema Face	25.0% 1/4 • 1 year
Psychiatric disorders Delirium	25.0% 1/4 • 1 year
Investigations Lymphocyte count increased	25.0% 1/4 • 1 year
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • 1 year
Gastrointestinal disorders Vomiting	25.0% 1/4 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • 1 year
Nervous system disorders Lethargy	25.0% 1/4 • 1 year
Infections and infestations Skin infection	25.0% 1/4 • 1 year
General disorders Death NOS	100.0% 4/4 • 1 year

Other adverse events
Measure	Participants With Mantle Cell Lymphoma n=4 participants at risk Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi Tafasitamab: Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Lenalidomide: Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).
Blood and lymphatic system disorders Anemia	25.0% 1/4 • 1 year
General disorders Fatigue	25.0% 1/4 • 1 year
Injury, poisoning and procedural complications Infusion related reaction	25.0% 1/4 • 1 year
Gastrointestinal disorders Nausea	25.0% 1/4 • 1 year
Investigations Creatinine increased	25.0% 1/4 • 1 year
Investigations Platelet count decreased	25.0% 1/4 • 1 year
Gastrointestinal disorders Dysphagia	25.0% 1/4 • 1 year
General disorders Edema face	25.0% 1/4 • 1 year
Musculoskeletal and connective tissue disorders Generalized muscle weakness	25.0% 1/4 • 1 year
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • 1 year

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3780