Actively Recruiting
Phase II Trial of Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE Chemotherapy as Salvage Therapy for Transplant Eligible Patients With Relapsed or Refractory Large B-Cell Lymphoma
Led by David Bond, MD · Updated on 2025-11-20
37
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving tafasitamab and lenalidomide followed by tafasitamab paired with the chemotherapy drugs carboplatin, etoposide, and ifosfamide (ICE regimen) for adults with large B-cell lymphoma that has returned after treatment or has not responded to previous therapy. This phase II trial focuses on patients eligible for stem cell transplant and aims to understand how well this treatment works to shrink or eliminate cancer, as well as its safety and side effects. Participants receive tafasitamab through intravenous (IV) infusion and lenalidomide by mouth. After 2 to 4 cycles of these drugs, patients receive additional treatment with tafasitamab combined with the ICE chemotherapy drugs administered intravenously. Each cycle lasts 28 days. During the study, patients may undergo imaging scans such as positron emission tomography (PET) or computed tomography (CT), blood draws, and possibly tissue biopsies to monitor their condition and response to treatment. Throughout the trial, researchers assess cancer response rates, including complete remission, and track overall survival and progression-free survival for up to five years. They also monitor side effects and treatment tolerability. Stem cell mobilization and successful autologous stem cell transplant rates after study treatment are evaluated. The study includes detailed analysis of tumor characteristics and response to future therapies. Participants are monitored closely with imaging, laboratory tests, and clinical evaluations during treatment and follow-up periods.
CONDITIONS
Brief 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
- Able and willing to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Considered eligible for stem cell transplant by treating physician
- Measurable disease by CT scan (at least 1.5 cm) or PET avid disease
- Received one prior line of chemo-immunotherapy including R-CHOP
- Eligible histologic diagnosis includes various large B cell lymphomas and transformed lymphomas as specified
- Absolute neutrophil count of at least 1000/mcL
- Platelet count of at least 75,000/mcL without recent transfusion
- Hemoglobin level at least 8.0 g/dL unless due to marrow involvement
- Serum total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), except Gilbert Syndrome cases
- AST and ALT less than or equal to 3 times ULN
- Serum creatinine clearance of at least 60 mL/min
- Female subjects of childbearing potential must have negative pregnancy test and agree to birth control measures
- Male subjects must agree to use contraception and avoid sperm donation during and after treatment
- Able to comply with pregnancy prevention risk management plan
- Willing to provide archival tissue from biopsy after frontline therapy
You will not qualify if you...
- Active central nervous system involvement by lymphoma
- Diffuse large B-cell lymphoma transformed from chronic lymphocytic leukemia or small lymphocytic lymphoma (Richter's syndrome)
- Prior solid organ or hematopoietic cell transplant
- History of other malignancies that may interfere with study
- Recent myocardial infarction or stroke within 6 months
- Significant cardiovascular disease or uncontrolled arrhythmia
- Active uncontrolled infection requiring IV antibiotics
- Major surgery within 4 weeks before treatment start (except diagnostic surgery)
- Prior lymphoma therapy completed less than 2 weeks before study treatment start (except corticosteroids for symptoms)
- HIV infection with low CD4 count or high viral load
- Active hepatitis B or C infection
- Known allergy or contraindication to study medications
- Prior treatment with anti-CD19 therapy or lenalidomide
- Gastrointestinal problems preventing oral medication absorption
- Rare hereditary conditions affecting sugar metabolism
- History of serious blood clots or thrombophilia without willingness for prophylaxis
- Not recovered from side effects of prior therapy as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 cycles of 28 days each
Participants receive tafasitamab intravenously and lenalidomide orally, followed by tafasitamab combined with ICE chemotherapy (etoposide, ifosfamide, and carboplatin) as salvage therapy for relapsed or refractory large B-cell lymphoma. Blood sample collections and imaging scans (PET or CT) occur throughout treatment, and tissue biopsy may be performed.
Visits occur during each treatment cycle with multiple infusions and assessments
Duration - Up to 5 years
Participants are monitored for long-term outcomes including response to therapy, progression-free survival, overall survival, and incidence of adverse events.
Periodic visits for assessments and sample collections
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
A
Aubree Dendorfer
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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