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Monomorphic B-Cell Post-Transplant Lymphoproliferative DisorderPhase 2NCT05786040

Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder

A Phase 2 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder and Polymorphic Post-Transplant Lymphoproliferative Disorder, run by Timothy Voorhees at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests how well tafasitamab and rituximab work for front-line treatment of patients with post-transplant lymphoproliferative disorder. Post-transplant lymphoproliferative disorder (PTLD) is the name for types of lymphoma that sometimes develop in people who have had a transplant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesUnited States
Study dates
23 Mar 2023to 31 Dec 2027
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

  • Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • Age >= 18 years at the time of consent
  • Karnofsky scale > 30% or Eastern Cooperative Oncology Group (ECOG) =< 3 (can be assessed after pre-phase steroids)
  • Histological evidence of B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; expresses CD19 and CD20, with or without EBV association, confirmed after biopsy or resection of tumor
  • Measurable disease of > 1.5 cm in diameter and/or bone marrow involvement
  • Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned
Show all 27Show fewer
  • No prior lines of therapy for PTLD (palliative radiation, steroids, antiviral therapy, and reduction in immunosuppression are allowed)
  • Human immunodeficiency virus (HIV) infection is allowed if viral load is undetectable at time of enrollment and CD4+ count > 200 cells/uL
  • Expected survival greater than 30 days
  • Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (obtained within 14 days prior to initiating study treatment)
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Platelets >= 50 x 10^9/L (obtained within 14 days prior to initiating study treatment)
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Creatinine clearance (mL/min) >= 30 mL/min (obtained within 14 days prior to initiating study treatment)
  • Cockcroft-Gault Equation
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Bilirubin =< 3.0 x upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level > 3.0 mg/dL if their conjugated bilirubin is =< 3.0 x ULN) (obtained within 14 days prior to initiating study treatment)
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Aspartate aminotransferase (AST) =< 3.0 x ULN (obtained within 14 days prior to initiating study treatment)
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Alanine aminotransferase (ALT) =< 3.0 x ULN (obtained within 14 days prior to initiating study treatment)
  • Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
  • Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided
  • Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of rituximab or tafasitamab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
  • Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of rituximab
  • Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial
  • Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

Who cannot join

  • Uncontrolled active infection. Patients requiring systemic therapy are eligible if the infection is deemed controlled by the investigator
  • Post-transplant lymphoproliferative disorder following liquid transplantation
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)
  • Subjects with central nervous system (CNS) involvement by PTLD
  • Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non-compensated hypertension (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 120 mmHg)
  • History of progressive multifocal leukoencephalopathy
Show all 12Show fewer
  • Active hepatitis B infection with positive viral polymerase chain reaction (PCR) from the blood. Subjects with active hepatitis B infection and undetectable viral PCR from the blood will be allowed with concurrent use of entecavir suppression
  • Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
  • Electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
  • Any condition, including the presence of laboratory values which is deemed by the clinician to place the subject at an unacceptable risk or confounds the ability to interpret the data from this study
  • Live virus vaccines must not be administered within 28 days of the start of study treatment
  • Any investigational treatments must have been completed at least 7 days prior to the start of study treatment

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States4 sites, 4 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Timothy J. Voorhees, MD, MSCR, 614-293-6943, timothy.voorhees@osumc.edu

    Timothy J. Voorhees, MD, MSCR

    Recruiting

  • University of North Carolina-Hillsborough Campus

    Hillsborough, North Carolina, 27278

    Christopher E. Dittus, DO, MPH, 919-966-4431, chris_dittus@med.unc.edu

    Elyse Schmidt, 919-966-4432, elyse_schmidt@med.unc.edu

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Anita A. Trupiano, 732-454-9795, ar2069@cinj.rutgers.edu

    Joanna Rhodes, MD

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Lindsey Gilstrap, 801-213-5652, lindsey.gilstrap@hci.utah.edu

    Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase II Study to Assess the Efficacy of Combined Tafasitamab and Rituximab in Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder

This phase II trial tests how well tafasitamab and rituximab work for front-line treatment of patients with post-transplant lymphoproliferative disorder. Post-transplant lymphoproliferative disorder (PTLD) is the name for types of lymphoma that sometimes develop in people who have had a transplant. It can affect people who are taking medicines to suppress their immune system. Tafasitamab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving the combination of tafasitamab and rituximab may work better in treating patients with post-transplant lymphoproliferative disorder.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate the rate of complete response (CR) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab in subjects with post-transplant lymphoproliferative disorder (PTLD).

SECONDARY OBJECTIVES:

  1. To describe the safety profile of treatment with combined rituximab and tafasitamab in subjects with PTLD.

II. To estimate the objective response rate (ORR), defined as clinical response (CR + partial response [PR]) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab in subjects with PTLD.

III. To determine the best overall response (BOR), defined as best clinical response (CR + PR) at either the completion of 4 cycles of weekly (or 7-day) treatments or 4 consolidation cycles (every 3 week) of combined rituximab and tafasitamab in subjects with PTLD.

IV. To estimate the rate of complete response (CR) after completion of consolidation treatments of combined rituximab and tafasitamab in subjects with PTLD.

  1. To estimate the progression free survival (PFS) in subjects with PTLD treated with rituximab and tafasitamab.

VI. To estimate the overall survival (OS) in subjects with PTLD treated with rituximab and tafasitamab.

EXPLORATORY OBJECTIVES:

  1. To describe baseline CD19 and CD20 expression on malignant lymphocytes by flow cytometry in subjects with PTLD.

II. To describe the relationship of tumor microenvironment characteristics using ribonucleic acid sequencing (RNASeq) with clinical response to combined rituximab and tafasitamab in subjects with PTLD.

III. To characterize the peripheral immunophenotype changes using cytometry by time-of-flight (CyTOF) from cycle 1 (C1) day 1 (D1) to cycle 5 (C5)D1 of combined rituximab and tafasitamab in subjects with PTLD.

IV. To describe the type of immunosuppression and amount reduced in subjects with PTLD.

  1. To describe the relationship between metabolic tumor volume at diagnosis and response to combined rituximab and tafasitamab in subjects with PTLD.

VI. To characterize Epstein-barr virus (EBV) methylation alterations in EBV positive PTLDs.

OUTLINE:

Patients receive tafasitamab intravenously (IV) and rituximab IV or subcutaneously (SC) on study. Patients who have CR or PR after 4 cycles may receive additional tafasitamab and rituximab on study. Patients also undergo positron emission tomography (PET) or computed tomography (CT), biopsy, and collection of blood samples throughout the trial.

Being tested
Biopsy, Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Rituximab

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 biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

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

    Undergo CT

  • Positron Emission TomographyProcedure or surgery

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

    Undergo PET

  • RituximabBiological

    Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody

    Given IV or SC

  • 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 NCT05786040
Study groupRoleWhat they receive
Treatment (tafasitamab, rituximab)ExperimentalPatients receive tafasitamab IV and rituximab IV or SC on study. Patients who have CR or PR after 4 cycles may receive additional tafasitamab and rituximab on study. Patients also undergo PET or CT, biopsy, and collection of blood samples throughout the trial.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Biological: Rituximab; Biological: Tafasitamab

What is being measured

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

  1. Rate of patients who achieve a complete response (CR)

    Assessed using Lugano criteria. Will be calculated as the number of patients who achieve CR divided by the number of evaluable patients, and presented with the 95% binomial confidence interval.

    Measured: within 1 week after 4 cycles of combined therapy

Secondary outcomes (6)

  1. Incidence of adverse events

    Adverse events will be described and classified per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events.

    Measured: Up to 28 days after the last dose of tafasitamab and rituximab

  2. Overall response rate

    Defined as clinical response (CR + partial response [PR]) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab using Lugano criteria.

    Measured: Up to 3 years

  3. Best overall response

    Defined as best clinical response (CR + PR) at the completion of either 4 cycles of weekly (or 7-day) treatments or 4 consolidation cycles (every 3 week) of combined rituximab and tafasitamab using Lugano criteria. Will be estimated and 95% confidence interval computed.

    Measured: Up to 3 years

  4. Rate of CR after completion of consolidation treatments

    Will be estimated and 95% confidence interval computed.

    Measured: Up to 3 years

  5. Progression free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: From the date of treatment initiation to date of progression or death, whichever occurs first, censoring patients who are alive without progression at time of last known follow-up, assessed up to 3 years

  6. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: From date of treatment initiation to date of death due to all causes, and censoring alive patients at date of last known follow-up, assessed up to 3 years

Timeline

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

  1. First posted27 Mar 2023
  2. Study start23 Mar 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786040
Sponsor's protocol ID
OSU-22114
Other IDs
NCI-2023-02048
Status last verified
Feb 2026
First submitted
13 Mar 2023
Last updated
14 Apr 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 Computed Tomography in people with Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder and Polymorphic Post-Transplant Lymphoproliferative Disorder, run by Timothy Voorhees at 4 sites 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 27 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients who achieve a complete response (CR) (time frame: within 1 week after 4 cycles of combined therapy). 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 NCT05786040.

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 14 Apr 2026.

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