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
David Bond, MD
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.
Description
PRIMARY OBJECTIVE: I. Evaluate the anti-tumor activity of tafasitamab and lenalidomide followed by tafasitamab and ICE as first salvage therapy for relapsed/ refractory large B cell lymphoma as assessed by the cumulative complete response rate after completion of 2 or 4 cycles of study treatment. SECONDARY OBJECTIVES: I. Evaluate the overall response rate to tafasitamab and lenalidomide followed by tafasitamab and ICE in transplant eligible patients with relapsed/ refractory large B cell lymphoma after 2-4 total cycles of treatment. II. Evaluate the overall and complete response rate to ta…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 pal…
Interventions
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- DrugEtoposide
Given IV
- DrugIfosfamide
Given IV
- DrugLenalidomide
Given PO
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio