Actively Recruiting
Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma
Led by David Bond, MD · Updated on 2025-11-20
37
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 years or older
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Considered eligible for transplant by treating physician
- Measurable disease by CT scan (at least 1.5 cm) or PET positive disease
- Received one prior line of chemo-immunotherapy such as R-CHOP
- Eligible histologic diagnosis including various specified large B cell lymphomas
- Absolute neutrophil count 1000/mcL or higher
- Platelets 75,000/mcL or higher without recent transfusion
- Hemoglobin 8.0 g/dL or higher unless due to marrow lymphoma involvement
- Serum total bilirubin 1.5 times upper normal limit or less (up to 3.0 mg/dL for Gilbert Syndrome)
- AST and ALT 3 times upper normal limit or less
- Serum creatinine clearance 60 mL/min or higher
- Female subjects of childbearing potential must have a negative pregnancy test and agree to birth control
- Male subjects must agree to use contraception and avoid sperm donation during and 3 months after treatment
- Willing to comply with pregnancy prevention plan
- Willing to provide archival tissue from biopsy after frontline therapy
You will not qualify if you...
- Active central nervous system lymphoma involvement
- DLBCL transformed from chronic lymphocytic leukemia or small lymphocytic lymphoma
- Prior solid organ or hematopoietic cell transplant
- History of other malignancy interfering with study
- Myocardial infarction or stroke in past 6 months
- Significant heart disease including uncontrolled arrhythmia or heart failure NYHA class 2-4
- Active uncontrolled infection or requiring IV antibiotics
- Major surgery within 4 weeks before treatment, except diagnostic surgery
- Prior lymphoma therapy completed less than 2 weeks before study therapy, except corticosteroids for symptom relief
- HIV infection with low CD4 count, resistant strain, or high viral load
- Active hepatitis B or C infection unless viral load is undetectable
- Allergy or contraindication to study medications
- Prior treatment with anti-CD19 therapy or lenalidomide
- Gastrointestinal problems affecting oral medication absorption
- Rare hereditary problems affecting sugar metabolism
- History of serious blood clots or thrombophilia unwilling to take clot prevention
- Not recovered from prior treatment toxicities as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
A
Aubree Dendorfer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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