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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma (NCT05821088) is a Phase 2 interventional studying Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by David Bond, MD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 37 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult patient (age 18 or older) - Willing and able to provide written willing to sign a consent form 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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 \[PI\]) Exclusion Criteria: * 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 * History or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption * History of deep venous thromboembolism threatening thromboembolism, or known thrombophilia AND not willing to take venous thromboembolism prophylaxis during the study period * Patients who in the opinion of the investigator have not recovered sufficiently from the adverse toxic events of prior therapy

Treatments Being Tested

PROCEDURE

Biopsy

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Lenalidomide

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET

BIOLOGICAL

Tafasitamab

Given IV

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05821088), the sponsor (David Bond, MD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05821088 clinical trial studying?

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 ifo… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05821088?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05821088?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05821088. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05821088. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.