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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05788289

Collaborator

Incyte Corporation (Industry)

Enrollment

Locations

Arm

Anticipated Duration (Months)

5.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma MCL	Drug: Tafasitamab Drug: Lenalidomide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Tafasitamab and Lenalidomide in Relapsed or Refractory Mantle Cell Lymphoma

Actual Study Start Date :

Mar 14, 2023

Anticipated Primary Completion Date :

Mar 14, 2025

Anticipated Study Completion Date :

Mar 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Tafasitamab Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length. Drug: Lenalidomide Participants will receive treatment with intravenous tafasitamab and oral lenalidomide for up to 12 cycles. Each cycle is 28 days in length.

Arm

Intervention/Treatment

Experimental: 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

Drug: Tafasitamab

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

Drug: Lenalidomide

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

Outcome Measures

Primary Outcome Measures

Overall Response Rate/ORR [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3x ULN, unless secondary to documented liver involvement by lymphoma. Patients with documented liver involvement by lymphoma may be included if AST and ALT are ≤ 5x ULN.
Willingness to receive adequate prophylaxis and/or therapy for thromboembolic events, unless contraindicated in the opinion of the investigator
Willingness to undergo confirmatory procedures for assessment of disease status and experimental studies as required by protocol, including bone marrow (BM) aspiration/biopsy, gastrointestinal endoscopy/colonoscopy with biopsy, and/or biopsy of other tissue when appropriate and medically feasible
Each patient must sign Informed Consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate
Short course systemic corticosteroids (total daily dose equivalent of prednisone 100mg or less) are permissible for disease control, improvement of performance status, or non-cancer indication if administered for ≤ 10 days and discontinued prior to initiation of study treatment
Willingness of patients who are able to become pregnant according to Revlimid/lenalidomide Risk Evaluation and Mitigation Strategy (REMS) criteria to undergo pregnancy testing in accordance with REMS requirements
Willingness of all patients to adhere to contraception requirements mandated by the Revlimid/lenalidomide REMS

Exclusion Criteria:

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.
Allogeneic stem cell transplantation within 3 months prior to signing the Informed Consent form, with evidence of graft-versus-host disease (GVHD), or receiving immunosuppressive therapy for GVHD.
Concurrent use of other anticancer or experimental treatments
No concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix or breast, adequately treated lentigo maligna melanoma, or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy previously treated for curative intent is permitted.
Administration of a live vaccine within 28 days prior to the start of study treatment (Cycle 1 Day 1).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (All protocol activities)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (All protocol activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York	United States	11553