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Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin LymphomaPhase 2NCT05821088

Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma

A Phase 2 study testing Biopsy, Biospecimen Collection and Carboplatin in people with 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, run by David Bond, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Biospecimen Collection and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
29 Jun 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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])

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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 tafasitamab and lenalidomide after two cycles of treatment in transplant eligible patients with relapsed/ refractory large B cell lymphoma.

III. Evaluate the rate of successful stem cell mobilization following study treatment.

IV. Evaluate the rate of successful completion of autologous stem cell transplant (ASCT) following study treatment, including patients treated with a total of 2 or 4 cycles of treatment.

  1. Evaluate the incidence of toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

VI. Evaluate the progression free and overall survival in the study population. VII. Compare progression free survival (PFS)/ overall survival (OS) (i.e. long-term outcomes) in patients who proceed to transplant after completing only 2 cycles of tafasitamab/lenalidomide (tafa/len) versus those completing 4 cycles of tafa/len followed by tafa+ICE.

EXPLORATORY OBJECTIVES:

  1. Evaluate the response rate to subsequent anti-CD19 CAR-T treatment in patients who go on to receive further therapy including for relapsed/ refractory disease.

II. Assess CD19 expression in patients with subsequent relapse or refractory disease following study treatment by immunohistochemistry.

III. Examine the association between clinical outcomes including complete response (CR) rate and pathological tumor characteristics (e.g. in activated B-cell [ABC]-type subgroup by gene expression profiling [GEP], non-germinal center [GC] subtype by Hans, "double/triple hit" phenotype by fluorescence in situ hybridization [FISH] and/or GEP).

IV. Examine the association between circulating tumor deoxyribonucleic acid (ctDNA) clearance and clinical outcomes including CR rate and PFS.

  1. Evaluate association between clinical outcomes and duration of response to first-line therapy < 12 months vs > 12 months.

OUTLINE:

Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO), etoposide IV, ifosfamide IV and carboplatin IV on study. Patients undergo positron emission tomography (PET) or computed tomography (CT), and undergo blood sample collection throughout the study. Patients may undergo tissue biopsy on study.

Being tested
Biopsy, Biospecimen Collection, Carboplatin, Computed Tomography, Etoposide
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • IfosfamideDrug

    Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan

    Given IV

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET

  • TafasitamabBiological

    Also called Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208

    Given IV

Study groups in NCT05821088
Study groupRoleWhat they receive
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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Carboplatin; Procedure: Computed Tomography; Drug: Etoposide; Drug: Ifosfamide; Drug: Lenalidomide; Procedure: Positron Emission Tomography; Biological: Tafasitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the end of Cycle (each cycle is 28 days)

Secondary outcomes (4)

  1. Overall response rate (ORR)

    Will be calculated with patients who achieve CR or partial remission (PR) at end of induction therapy as the numerator and all eligible patients who start treatment as the denominator, with a 95% binomial confidence interval provided.

    Measured: Up to 5 years

  2. Progression free survival

    Will be estimated by the method of Kaplan-Meier.

    Measured: From start of treatment to progression or death, whichever occurs first, assessed up to 2 years

  3. Incidence of adverse events

    Will be conducted through the review of toxicity data. All adverse events will be summarized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 criteria, and tabulated across all patients who received any treatment with a focus on severe (grade 3+) adverse events and toxicities that are deemed at least possibly related to study treatment. The proportion of patients who go off treatment due to adverse events or those who refuse to continue treated for lesser toxicities will also be captured.

    Measured: Up to 5 years

  4. Tolerability of treatment

    Will be assessed through assessing the number of patients who required dose modifications and/or dose delays.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start29 Jun 2023
  3. Primary completion19 Feb 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821088
Sponsor's protocol ID
OSU-22140
Other IDs
NCI-2023-02612
Status last verified
Jul 2026
First submitted
7 Apr 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy, Biospecimen Collection and Carboplatin in people with 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, run by David Bond, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission (CR) rate (time frame: At the end of Cycle (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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