A Phase II Trial of Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE As Salvage Therapy for Transplant Eligible Patients with Relapsed/ Refractory Large B-Cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II clinical trial evaluates tafasitamab and lenalidomide followed by tafasitamab and the carboplatin, etoposide and ifosfamide (ICE) regimen as salvage therapy for transplant eligible patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide may have antineoplastic activity which may help block the formation of growths that may become cancer. Drugs used in chemotherapy, such as carboplatin, etoposide and ifosfamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tafasitamab and lenalidomide followed by ICE may be a better treatment for patients with relapsed or refractory large B-cell lymphomas.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Adult patient (age 18 or older)

• Willing and able to provide written informed consent for the trial, assent when appropriate may be obtained per institutional guidelines

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

• Considered transplant eligible by the treating physician

• Measurable disease by CT (defined as \>= 1.5 cm in diameter) or one or more area of PET avid disease

• Have received one line of prior chemo-immunotherapy (i.e. cyclophosphamide, doxorubicin, prednisone, rituximab and vincristine \[R-CHOP\]). Note that corticosteroids for palliation of symptoms and radiation consolidation are not considered a line of therapy for purposes of eligibility determination

• Eligible histologic diagnosis includes: Diffuse large B cell lymphoma not otherwise specified (NOS), T cell histiocyte rich large B cell lymphoma, primary mediastinal B Cell lymphoma, follicular lymphoma grade 3B, high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, high grade B cell lymphoma NOS, DLBCL transformed from follicular lymphoma, DLBCL transformed from marginal zone lymphoma, DLBCL leg type, and B cell lymphoma unclassifiable (with features intermediate between DLBCL and classical Hodgkin's lymphoma)

• Absolute neutrophil count \>= 1000 / mcL

• Platelets \>= 75,000 / mcL in absence of transfusion support within 7 days of determining eligibility

• Hemoglobin \>= 8.0 g/dL, with exception of cases in which cytopenias are due to marrow involvement by lymphoma

• Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL)

• Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3.0 x ULN

• Serum creatinine clearance \>= 60 mL/min (calculated according to institutional standard)

• Female subjects of childbearing potential should have a negative serum pregnancy test at screening and within 24 hours of receiving the first dose of study medication

• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 months following the last dose of study treatment. Subjects should agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. Subjects of childbearing potential are patients who have not been surgically sterilized and have not been free from menses for \> 1 year

• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study therapy. Males must refrain from donating sperm during study participation and for 3 months after last dose of study medication

• In the opinion of the investigator, patients must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events and be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan

• Willing to provide archival tissue from biopsy performed after frontline systemic therapy (If prior archival tissue is unavailable, exceptions may be granted by the study principal investigator \[PI\])

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Backup
Aubree Dendorfer
Aubree.dendorfer@osumc.edu
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 37
Treatments
Experimental: Treatment (tafasitamab, lenalidomide, ICE regimen)
Patients receive tafasitamab IV, lenalidomide PO, etoposide IV, ifosfamide IV and carboplatin IV on study. Patients undergo PET or CT, and undergo blood sample collection throughout the study. Patients may undergo tissue biopsy on study.
Sponsors
Leads: David Bond, MD

This content was sourced from clinicaltrials.gov

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