Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma
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
2 other identifiers
interventional
37
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 20, 2025
November 1, 2025
3.5 years
April 7, 2023
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete remission (CR) rate
Will be defined as patients who have achieved CR after two cycles (tafasitamab and lenalidomide) or four cycles as assessed by positron emission tomography (PET) imaging.
At the end of Cycle (each cycle is 28 days)
Secondary Outcomes (4)
Overall response rate (ORR)
Up to 5 years
Progression free survival
From start of treatment to progression or death, whichever occurs first, assessed up to 2 years
Incidence of adverse events
Up to 5 years
Tolerability of treatment
Up to 5 years
Study Arms (1)
Treatment (tafasitamab, lenalidomide, ICE regimen)
EXPERIMENTALPatients 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.
Interventions
Undergo tissue biopsy
Undergo blood sample collection
Given IV
Undergo CT
Given IV
Given IV
Given PO
Undergo PET
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- Known active central nervous system involvement by lymphoma, including leptomeningeal involvement
- DLBCL transformed from chronic lymphocytic leukemia or small lymphocytic lymphoma (Richter's syndrome)
- Prior solid organ transplant
- Prior hematopoietic cell transplant
- History of other malignancy that could affect compliance with the protocol or interpretation of results in the opinion of the investigator
- Myocardial infarction or cerebrovascular accident within the past 6 months
- Clinically significant cardiovascular disease including uncontrolled arrhythmia or New York Heart Association Class 2-4 congestive heart failure
- Active uncontrolled infection or infection requiring IV antibiotic therapy
- Major surgery within 4 weeks prior to start of treatment other than surgery performed for diagnosis
- Prior lymphoma therapy should be completed greater than two weeks from the start of protocol therapy, with exception of patients receiving corticosteroids for palliation of symptoms
- Human immunodeficiency virus (HIV) infection AND CD4 count \< 350 cells/ mm\^3, evidence of resistant strain of HIV, or HIV viral load \>= 50 copies HIV ribonucleic acid (RNA)/mL if on highly active antiretroviral therapy (HAART) or HIV viral load \>= 10,000 copies HIV RNA/mL if not on anti-HIV therapy
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen \[HBsAg\] and positive hepatitis B core antibody \[HBcAb\]) are eligible if HBV DNA is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV RNA. Testing to be done only in patients suspected of having infections or exposures
- Known contraindication to any medication in the treatment plan, including known hypersensitivity
- Prior treatment with anti-CD19 targeted therapy or lenalidomide
- Gastrointestinal abnormalities including the inability to take oral medication, requirement of intravenous alimentation, or prior surgical procedure resulting in impaired enteral absorption of medication
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Bond, MDlead
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Bond, MD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 7, 2023
First Posted
April 20, 2023
Study Start
June 29, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share