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

NCT05788289 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 22-380
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine if the combination of tafasitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma.

Conditions

Mantle Cell Lymphoma; MCL

Keywords

Mantle Cell Lymphoma; MCL; R/R MCL; Tafasitamab; Lenalidomide; Memorial Sloan Kettering Cancer Center; 22-380

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate/ORR

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

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

Study Arms (1)

Participants with Mantle Cell Lymphoma

EXPERIMENTAL

Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi

Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Tafasitamab DRUG

Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length.

Participants with Mantle Cell Lymphoma

Lenalidomide DRUG

Lenalidomide will be self-administered by patients orally on days 1-21 of each 28-day cycle of induction (cycles 1 through 12).

Participants with Mantle Cell Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of signing Informed Consent
• Karnofsky performance status (KPS) ≥ 70% (see Appendix A)
• Pathologically confirmed diagnosis of R/R MCL
• Previously treated with at least one prior line of systemic therapy for MCL, at least one of which must have been a BTKi
• If patient previously received CD19-directed therapy (such as CAR-T therapy), then there must be evidence of CD19 expression confirmed by immunohistochemistry or flow cytometry per institutional guidelines. This must be confirmed on a biopsy performed after receipt of CD19-directed therapy.
• Previous systemic chemotherapy must have been discontinued at least 2 weeks prior to C1D1 and previous anti-cancer radiation therapy or targeted therapy must be discontinued prior to initiation of treatment on study
• All adverse effects should resolve to grade 1 or baseline (excluding alopecia)
• Presence of evaluable disease
• Measurable disease on radiologic assessment as defined by Lugano criteria: at least one nodal lesion (\> 1.5cm in long axis) or extranodal lesion (\> 1.0cm in long axis) measurable in 2 dimensions1,2
• Adequate bone marrow and organ function:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mcL, unless felt to be secondary to underlying MCL
• Platelet count ≥ 90,000 cells/mcL, unless felt to be secondary to underlying MCL
• Renal function assessed by calculated Cockcroft-Gault creatinine clearance (CrCl; see Appendix B) ≥ 30mL/min. See 10.0 Treatment Plan, Table 10-1, for lenalidomide dose adjustment for CrCl ≥ 30mL/min and \< 60mL/min.
• Hepatic function:
• Total bilirubin \< 2.5x upper limit of normal (ULN), unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if total bilirubin is ≤ 5x ULN.

You may not qualify if:

• Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the patient's safety or put the study outcomes at undue risk
• History of human immunodeficiency virus (HIV) unless all of the following criteria are met:31
• CD4+ T-cell count ≥ 250 cells/mcL
• No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 1 year prior to signing Informed Consent form
• Stable (no change in regimen for ≥ 4 weeks) and effective antiretroviral regimen, and HIV viral load \< 400 copies/mL within 4 weeks prior to signing Informed Consent form
• Hepatitis B or C with detectable viral load requiring antiviral therapy
• Pregnant or lactating
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to cycle 1 day 1
• Clinical significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Active central nervous system lymphoma
• Patients who, in the opinion of the investigator, have not recovered sufficiently from adverse effects of prior therapies
• Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy
• Lenalidomide exposure within 12 months prior to Day 1 of Cycle 1
• History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, lenalidomide, and/or excipients contained in the study drug formulations
• Autologous stem cell transplantation (ASCT) within 3 months prior to signing the Informed Consent form. Patients with more distant history of ASCT must exhibit full hematologic recovery before enrollment into this study.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Incyte Corporation: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Anita Kumar, MD
• Organization: Memorial Sloan Kettering Cancer Center

kumara2@mskcc.org

646-608-3780

Study Officials

• Anita Kumar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: March 14, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 25, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)